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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02601209
Other study ID # NCI-2015-01929
Secondary ID NCI-2015-01929A0
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date November 30, 2015
Est. completion date July 11, 2022

Study information

Verified date July 2022
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase I/II trial studies the side effects and best dose of sapanisertib and to see how well it works compared to pazopanib hydrochloride in treating patients with sarcoma that is too large to be removed (locally advanced) or has spread to other areas of the body (metastatic). Sapanisertib and pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Description:

PRIMARY OBJECTIVES: I. To determine the safety and maximum tolerable dose of sapanisertib (MLN0128 [TAK-228]) within this patient population. (Phase I) II. To determine the differences in progression-free survival (PFS) in patients with sarcoma who receive MLN0128 (TAK-228) as compared to pazopanib (pazopanib hydrochloride). (Phase II) SECONDARY OBJECTIVES: I. To evaluate adverse events. (Phase I/II) II. To evaluate overall response rate (ORR), clinical benefit rate (CBR), and duration of response (DOR). (Phase I/II) III. To evaluate time to progression (TTP) and overall survival (OS). (Phase I/II) EXPLORATORY OBJECTIVES: I. To evaluate PFS and secondary endpoints within patients crossing over to MLN0128 (TAK-228), upon disease progression during treatment with pazopanib. (Phase II) II. To evaluate the 4 month CBR observed within patients treated with MLN0128 (TAK-228) and grouped by histologically defined cohorts. (Phase II) OUTLINE: This is a phase I, dose-escalation study, followed by a randomized phase II study. PHASE I: Patients receive sapanisertib orally (PO) on days 1, 8, 15, and 22 in the absence of disease progression or unacceptable toxicity. PHASE II: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive sapanisertib as in Phase I. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive pazopanib hydrochloride PO once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm I. After completion of study treatment, patients are followed up at 4 weeks and then every 6 months for 2 years.


Recruitment information / eligibility

Status Terminated
Enrollment 151
Est. completion date July 11, 2022
Est. primary completion date December 7, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients must have slides available for submission to central pathology review; this review is mandatory prior to registration to confirm eligibility and proper cohort assignment - HISTOLOGIC COHORT 1: Undifferentiated pleomorphic sarcoma (includes: malignant fibrous histiocytoma, myxofibrosarcoma, high grade sarcoma not otherwise specified [NOS]) - HISTOLOGIC COHORT 2: Leiomyosarcoma (either uterine or extra-uterine) - HISTOLOGIC COHORT 3: Other (either malignant peripheral nerve sheath tumor or synovial sarcoma); during the phase II portion of the study, enrollment will be limited to maximum of 25 patients in this cohort - Note that the phase I is limited to the histologic subtypes listed above; since patients will be enrolling onto dose cohorts during the phase I, they will not enroll onto specific histologic cohorts, although the histologic subtype informed will be collected during patient enrollment - Histologic documentation: Eligible patients must have histopathologically confirmed sarcoma of one of the subtypes listed, by central review - Locally advanced or metastatic disease; locally advanced disease is defined as disease not amenable to local therapy such as surgery and/or radiation - Measurable disease - Progression on at least one prior systemic chemotherapy for advanced, unresectable or metastatic disease; prior adjuvant or neoadjuvant therapy is not included as prior systemic chemotherapy unless treatment occurred within the 6 months prior to study enrollment - There is no limit to the number of prior lines of treatment a patient has received - No treatment with biological therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registration - No treatment with radiation therapy =< 28 days before study registration - Patients should have resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, grade 1 or less - Prior treatment with pazopanib or any phosphoinositide 3-kinase (PI3K), mTOR, protein kinase B (AKT), or dual PI3K/mTOR complex (CREB regulated transcription coactivator [TORC]1/TORC2) inhibitors will be prohibited - Not pregnant and not nursing; because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown and an agent that has known genotoxic, mutagenic and teratogenic effects; therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required - Eastern Cooperative Oncology Group (ECOG) performance status =< 1 - Patient history: patients who have any of the following are NOT eligible: - Central nervous system (CNS): Symptomatic, untreated, or uncontrolled brain metastases present - Heme: Active bleeding or bleeding diathesis - Gastrointestinal (GI): - Abdominal fistula, GI perforation, or intra-abdominal abscess within 28 days prior to registration - Acute GI bleed within 28 days of registration - Diabetes mellitus: Patients with diabetes mellitus with inadequate control, based on either a glycosylated hemoglobin (Hgb A1c) of > 7.0 or fasting blood glucose above or equal to 130 mg/dL - Cardiac and vascular disorders: - History of congenital long QT syndrome or torsades de pointes - Any arrhythmia that is currently not rate-controlled (rate between 60 and 100) - Prolongation of corrected QT interval via Fridericia's formula (QTcF) > 480 msec - Ongoing unstable angina - Symptomatic peripheral vascular disease - Arterial thrombosis within 28 days of registration including transient ischemic attack (TIA), cerebrovascular accident (CVA), myocardial infarction (MI) - Patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) must be on a stable dose of anticoagulation for 14 days prior to registration - Uncontrolled hypertension, defined as blood pressure (BP) > 140/90 - Multi gated acquisition scan (MUGA) with ejection fraction (EF), 50% or echocardiogram (echo) with low EF - Class III or IV congestive heart failure (CHF) within 28 days of registration - Chronic concomitant treatment with proton pump inhibitors must discontinue the drug for 7 days prior to registration on the study - Chronic concomitant treatment with strong inhibitors of CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study - Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment - Absolute neutrophil count (ANC) >= 1,500/mm^3 - Platelet count >= 100,000/mm^3 - Creatinine =< 1.5 x upper limit of normal (ULN) - Total bilirubin =< 1.5 x upper limit of normal (ULN); unless patient has Gilbert disease - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN); if liver metastases, =< 5 x upper limit of normal (ULN) - Urine protein creatinine (UPC) =< 1; if UPC >= 1, then a 24-hour urine protein must be assessed; eligible patients must have a 24-hour urine protein value < 1 g/L - Thyroid stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH however if the Free T4 is normal and patient is clinically euthyroid, patient is eligible

Study Design


Related Conditions & MeSH terms

  • High Grade Sarcoma
  • Histiocytoma, Malignant Fibrous
  • Leiomyosarcoma
  • Metastatic Leiomyosarcoma
  • Metastatic Malignant Peripheral Nerve Sheath Tumor
  • Metastatic Synovial Sarcoma
  • Metastatic Undifferentiated Pleomorphic Sarcoma
  • Metastatic Unresectable Sarcoma
  • Myxofibrosarcoma
  • Nerve Sheath Neoplasms
  • Recurrence
  • Recurrent Leiomyosarcoma
  • Recurrent Malignant Peripheral Nerve Sheath Tumor
  • Recurrent Synovial Sarcoma
  • Recurrent Undifferentiated Pleomorphic Sarcoma
  • Sarcoma
  • Sarcoma, Synovial
  • Stage III Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IIIA Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IIIB Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IIIC Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IV Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IVA Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IVB Uterine Corpus Leiomyosarcoma AJCC v8
  • Unresectable Leiomyosarcoma

Intervention

Drug:
Pazopanib
Given PO
Pazopanib Hydrochloride
Given PO
Sapanisertib
Given PO

Locations

Country Name City State
United States Pali Momi Medical Center 'Aiea Hawaii
United States Queen's Cancer Center - Pearlridge 'Aiea Hawaii
United States The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii
United States Providence Regional Cancer System-Aberdeen Aberdeen Washington
United States Southwest Gynecologic Oncology Associates Inc Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Community Hospital of Anaconda Anaconda Montana
United States Alaska Breast Care and Surgery LLC Anchorage Alaska
United States Alaska Oncology and Hematology LLC Anchorage Alaska
United States Alaska Women's Cancer Care Anchorage Alaska
United States Anchorage Associates in Radiation Medicine Anchorage Alaska
United States Anchorage Oncology Centre Anchorage Alaska
United States Anchorage Radiation Therapy Center Anchorage Alaska
United States Katmai Oncology Group Anchorage Alaska
United States Providence Alaska Medical Center Anchorage Alaska
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States PCR Oncology Arroyo Grande California
United States AdventHealth Infusion Center Asheville Asheville North Carolina
United States Duluth Clinic Ashland Ashland Wisconsin
United States Northwest Wisconsin Cancer Center Ashland Wisconsin
United States Sutter Auburn Faith Hospital Auburn California
United States Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
United States University of Colorado Hospital Aurora Colorado
United States Saint Alphonsus Medical Center-Baker City Baker City Oregon
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Flaget Memorial Hospital Bardstown Kentucky
United States Medical Center of Baton Rouge Baton Rouge Louisiana
United States Ochsner Health Center-Summa Baton Rouge Louisiana
United States Nebraska Medicine-Bellevue Bellevue Nebraska
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Saint Charles Health System Bend Oregon
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Billings Clinic Cancer Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States Parkland Health Center-Bonne Terre Bonne Terre Missouri
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Bozeman Deaconess Hospital Bozeman Montana
United States Essentia Health Saint Joseph's Medical Center Brainerd Minnesota
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States Harrison Medical Center Bremerton Washington
United States Saint Joseph Mercy Brighton Brighton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States Henry Ford Cancer Institute-Downriver Brownstown Michigan
United States Saint Joseph Regional Cancer Center Bryan Texas
United States Roswell Park Cancer Institute Buffalo New York
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Highline Medical Center-Main Campus Burien Washington
United States Mills-Peninsula Medical Center Burlingame California
United States University of Vermont and State Agricultural College Burlington Vermont
United States University of Vermont Medical Center Burlington Vermont
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Joseph Mercy Canton Canton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Caro Cancer Center Caro Michigan
United States Carson Tahoe Regional Medical Center Carson City Nevada
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Eden Hospital Medical Center Castro Valley California
United States Centralia Oncology Clinic Centralia Illinois
United States Providence Regional Cancer System-Centralia Centralia Washington
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Memorial Hospital Chattanooga Tennessee
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Northwestern University Chicago Illinois
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States TriHealth Cancer Institute-Anderson Cincinnati Ohio
United States TriHealth Cancer Institute-Westside Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Providence Cancer Institute Clackamas Clinic Clackamas Oregon
United States Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States AdventHealth Infusion Center Haywood Clyde North Carolina
United States Big Horn Basin Cancer Center Cody Wyoming
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Bay Area Hospital Coos Bay Oregon
United States Commonwealth Cancer Center-Corbin Corbin Kentucky
United States Alegent Health Mercy Hospital Council Bluffs Iowa
United States Greater Regional Medical Center Creston Iowa
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States Geisinger Medical Center Danville Pennsylvania
United States Sutter Davis Hospital Davis California
United States Beaumont Hospital - Dearborn Dearborn Michigan
United States Henry Ford Medical Center-Fairlane Dearborn Michigan
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Essentia Health - Deer River Clinic Deer River Minnesota
United States Porter Adventist Hospital Denver Colorado
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes Minnesota
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Mercy Medical Center Durango Colorado
United States Southwest Oncology PC Durango Colorado
United States Duke University Medical Center Durham North Carolina
United States Prisma Health Cancer Institute - Easley Easley South Carolina
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin
United States Swedish Cancer Institute-Edmonds Edmonds Washington
United States Crossroads Cancer Center Effingham Illinois
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Walter Knox Memorial Hospital Emmett Idaho
United States Saint Elizabeth Hospital Enumclaw Washington
United States Illinois CancerCare-Eureka Eureka Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Essentia Health Cancer Center-South University Clinic Fargo North Dakota
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Sanford South University Medical Center Fargo North Dakota
United States Farmington Health Center Farmington Utah
United States Saint Francis Hospital Federal Way Washington
United States Lake Region Healthcare Corporation-Cancer Care Fergus Falls Minnesota
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Poudre Valley Hospital Fort Collins Colorado
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Essentia Health - Fosston Fosston Minnesota
United States Palo Alto Medical Foundation-Fremont Fremont California
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Glens Falls Hospital Glens Falls New York
United States Mountain Blue Cancer Care Center Golden Colorado
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Wayne Memorial Hospital Goldsboro North Carolina
United States CHI Health Saint Francis Grand Island Nebraska
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Prisma Health Greenville Memorial Hospital Greenville South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan
United States Hackensack University Medical Center Hackensack New Jersey
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Saint Peter's Community Hospital Helena Montana
United States Cancer and Blood Specialists-Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada
United States GenesisCare USA - Henderson Henderson Nevada
United States Las Vegas Cancer Center-Henderson Henderson Nevada
United States OptumCare Cancer Care at Seven Hills Henderson Nevada
United States AdventHealth Hendersonville Hendersonville North Carolina
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States Essentia Health Hibbing Clinic Hibbing Minnesota
United States Pulmonary Medicine Center of Chattanooga-Hixson Hixson Tennessee
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Island Urology Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Kuakini Medical Center Honolulu Hawaii
United States Queen's Cancer Cenrer - POB I Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
United States Cancer Center of Kansas-Independence Independence Kansas
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States Allegiance Health Jackson Michigan
United States Baptist MD Anderson Cancer Center Jacksonville Florida
United States Mayo Clinic in Florida Jacksonville Florida
United States Onslow Memorial Hospital Jacksonville North Carolina
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States Essentia Health - Jamestown Clinic Jamestown North Dakota
United States Capital Region Southwest Campus Jefferson City Missouri
United States Kalispell Regional Medical Center Kalispell Montana
United States CHI Health Good Samaritan Kearney Nebraska
United States Heartland Hematology and Oncology Kearney Nebraska
United States Kadlec Clinic Hematology and Oncology Kennewick Washington
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Providence Regional Cancer System-Lacey Lacey Washington
United States Marshfield Clinic - Ladysmith Center Ladysmith Wisconsin
United States Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado
United States Saint Anthony Hospital Lakewood Colorado
United States Saint Clare Hospital Lakewood Washington
United States Sparrow Hospital Lansing Michigan
United States Ann M Wierman MD LTD Las Vegas Nevada
United States Cancer and Blood Specialists-Shadow Las Vegas Nevada
United States Cancer and Blood Specialists-Tenaya Las Vegas Nevada
United States Cancer Therapy and Integrative Medicine Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada
United States Desert West Surgery Las Vegas Nevada
United States GenesisCare USA - Fort Apache Las Vegas Nevada
United States GenesisCare USA - Las Vegas Las Vegas Nevada
United States GenesisCare USA - Vegas Tenaya Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada
United States Las Vegas Cancer Center-Medical Center Las Vegas Nevada
United States OptumCare Cancer Care at Charleston Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States OptumCare Cancer Care at MountainView Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Central Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada
United States Summerlin Hospital Medical Center Las Vegas Nevada
United States University Cancer Center Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States Beebe Medical Center Lewes Delaware
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Lewistown Hospital Lewistown Pennsylvania
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska
United States Littleton Adventist Hospital Littleton Colorado
United States Hope Cancer Clinic Livonia Michigan
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Saint Joseph London London Kentucky
United States Longmont United Hospital Longmont Colorado
United States Rocky Mountain Cancer Centers-Longmont Longmont Colorado
United States PeaceHealth Saint John Medical Center Longview Washington
United States Los Angeles County-USC Medical Center Los Angeles California
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States Jewish Hospital Louisville Kentucky
United States Saints Mary and Elizabeth Hospital Louisville Kentucky
United States UofL Health Medical Center Northeast Louisville Kentucky
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States Michigan Breast Specialists-Macomb Township Macomb Michigan
United States Norris Cotton Cancer Center-Manchester Manchester New Hampshire
United States Cancer Center of Kansas-Manhattan Manhattan Kansas
United States Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Loyola University Medical Center Maywood Illinois
United States Cancer Center of Kansas - McPherson McPherson Kansas
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Community Medical Hospital Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Memorial Medical Center Modesto California
United States Palo Alto Medical Foundation-Camino Division Mountain View California
United States Palo Alto Medical Foundation-Gynecologic Oncology Mountain View California
United States Saint Alphonsus Medical Center-Nampa Nampa Idaho
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States Norris Cotton Cancer Center-Nashua Nashua New Hampshire
United States Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut
United States Yale University New Haven Connecticut
United States Ochsner Baptist Medical Center New Orleans Louisiana
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Memorial Sloan Kettering Cancer Center New York New York
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Christiana Gynecologic Oncology LLC Newark Delaware
United States Delaware Clinical and Laboratory Physicians PA Newark Delaware
United States Helen F Graham Cancer Center Newark Delaware
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Providence Newberg Medical Center Newberg Oregon
United States USC Norris Oncology/Hematology-Newport Beach Newport Beach California
United States Cancer Center of Kansas - Newton Newton Kansas
United States Sutter Cancer Research Consortium Novato California
United States Henry Ford Medical Center-Columbus Novi Michigan
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Hematology and Oncology Consultants PC Omaha Nebraska
United States Nebraska Medicine-Village Pointe Omaha Nebraska
United States Nebraska Methodist Hospital Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States Memorial GYN Plus Ooltewah Tennessee
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States University of Kansas Cancer Center-Overland Park Overland Park Kansas
United States Hope Cancer Care of Nevada-Pahrump Pahrump Nevada
United States Palo Alto Medical Foundation Health Care Palo Alto California
United States Midlands Community Hospital Papillion Nebraska
United States Essentia Health - Park Rapids Park Rapids Minnesota
United States Parker Adventist Hospital Parker Colorado
United States Rocky Mountain Cancer Centers-Parker Parker Colorado
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Keck Medical Center of USC Pasadena Pasadena California
United States Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States 21st Century Oncology-Pontiac Pontiac Michigan
United States Hope Cancer Center Pontiac Michigan
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Huron Medical Center PC Port Huron Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Summit Cancer Centers-Post Falls Post Falls Idaho
United States Geisinger Cancer Services-Pottsville Pottsville Pennsylvania
United States Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Illinois CancerCare-Princeton Princeton Illinois
United States Rocky Mountain Cancer Centers - Pueblo Pueblo Colorado
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Northwest Hospital Center Randallstown Maryland
United States Saint Charles Health System-Redmond Redmond Oregon
United States Beebe Health Campus Rehoboth Beach Delaware
United States Radiation Oncology Associates Reno Nevada
United States Renown Regional Medical Center Reno Nevada
United States Saint Mary's Regional Medical Center Reno Nevada
United States Lakeview Medical Center-Marshfield Clinic Rice Lake Wisconsin
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States Mayo Clinic in Rochester Rochester Minnesota
United States University of Rochester Rochester New York
United States Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan
United States Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California
United States Sutter Roseville Medical Center Roseville California
United States Sutter Medical Center Sacramento Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Norris Cotton Cancer Center-North Saint Johnsbury Vermont
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Siteman Cancer Center-South County Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Cancer Center of Kansas - Salina Salina Kansas
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States California Pacific Medical Center-Pacific Campus San Francisco California
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Essentia Health Sandstone Sandstone Minnesota
United States Palo Alto Medical Foundation-Santa Cruz Santa Cruz California
United States Sutter Pacific Medical Foundation Santa Rosa California
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Low Country Cancer Care Savannah Georgia
United States Summit Cancer Care-Candler Savannah Georgia
United States Community Medical Center Scranton Pennsylvania
United States TidalHealth Nanticoke / Allen Cancer Center Seaford Delaware
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Kaiser Permanente Washington Seattle Washington
United States Pacific Gynecology Specialists Seattle Washington
United States Seattle Cancer Care Alliance Seattle Washington
United States Swedish Medical Center-Ballard Campus Seattle Washington
United States Swedish Medical Center-Cherry Hill Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States University of Washington Medical Center - Montlake Seattle Washington
United States PeaceHealth United General Medical Center Sedro-Woolley Washington
United States Geisinger Medical Oncology-Selinsgrove Selinsgrove Pennsylvania
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Providence Regional Cancer System-Shelton Shelton Washington
United States Jewish Hospital Medical Center South Shepherdsville Kentucky
United States Welch Cancer Center Sheridan Wyoming
United States Siouxland Regional Cancer Center Sioux City Iowa
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States MultiCare Deaconess Cancer and Blood Specialty Center - Downtown Spokane Washington
United States MultiCare Deaconess Cancer and Blood Specialty Center - North Spokane Washington
United States Spokane Valley Cancer Center-Mayfair Spokane Washington
United States Spokane Valley Cancer Center-Mission Spokane Washington
United States MultiCare Deaconess Cancer and Blood Specialty Center - Valley Spokane Valley Washington
United States Memorial Medical Center Springfield Illinois
United States Mercy Medical Center Springfield Massachusetts
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Geisinger Medical Group State College Pennsylvania
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Ascension Saint Michael's Hospital Stevens Point Wisconsin
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Palo Alto Medical Foundation-Sunnyvale Sunnyvale California
United States Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri
United States Southwest Illinois Health Services LLP Swansea Illinois
United States Franciscan Research Center-Northwest Medical Plaza Tacoma Washington
United States Northwest Medical Specialties PLLC Tacoma Washington
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States Sanford Thief River Falls Medical Center Thief River Falls Minnesota
United States Rocky Mountain Cancer Centers-Thornton Thornton Colorado
United States Banner University Medical Center - Tucson Tucson Arizona
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville California
United States Sutter Solano Medical Center/Cancer Center Vallejo California
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Essentia Health Virginia Clinic Virginia Minnesota
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States Advanced Breast Care Center PLLC Warren Michigan
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Macomb Hematology Oncology PC Warren Michigan
United States Michigan Breast Specialists-Warren Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States MedStar Georgetown University Hospital Washington District of Columbia
United States MedStar Washington Hospital Center Washington District of Columbia
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Henry Ford West Bloomfield Hospital West Bloomfield Michigan
United States Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States William E Kahlert Regional Cancer Center/Sinai Hospital Westminster Maryland
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Dickstein Cancer Treatment Center White Plains New York
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Christiana Care Health System-Wilmington Hospital Wilmington Delaware
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Sanford Cancer Center Worthington Worthington Minnesota
United States Providence Regional Cancer System-Yelm Yelm Washington
United States Huron Gastroenterology PC Ypsilanti Michigan
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Progression-free Survival (PFS) (Phase II) Defined as either disease progression or death (in cases where patients have died without evidence of disease progression) in crossover patients. Up to 2 years
Other Duration of Response in Crossover Patients (Phase II) Will be analyzed using Kaplan-Meier methodology. Time between each patient's best tumor response and progression>>> (or date of last disease assessment for patients who die without progression or are lost to follow-up), assessed up to 2 years
Other Time to Progression (TTP) in Crossover Patients (Phase II) Kaplan-Meier methodology will be used to estimate the distribution of>>> TTP. Time between date the patient initiated sapanisertib and disease progression, assessed up to 2 years
Other Overall Survival (OS) in Crossover Patients (Phase II) Kaplan-Meier methodology will be used to estimate the distribution of>>> OS. Time between date the patient initiated sapanisertib and death due to any cause (or last contact for surviving patients and those lost to follow-up), assessed up to 2 years
Other Cohort-specific Evaluation of 4-month Clinical Benefit Rate (CBR) (Phase II, Analysis Group II) Analyses will be exploratory in nature. 4 months
Primary Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) The Maximum Tolerated Dose (MTD) of sapanisertib (MLN0128) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. The number of patients reporting a dose-limiting event is reported. 28 days
Primary Progression-free Survival (PFS) (Phase II Analysis Group 2 - Initial Treatment Period) Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and an upper confidence boundary from a 1-sided, 85% confidence interval are estimated using the Kaplan-Meier methods. Up to 2 years
Secondary The Number of Patients Who Experienced Grade 3+ Adverse Events (Phase II Analysis Group 2 - Initial Treatment Period) The number of patients who experienced grade 3+ adverse events for Phase II Analysis Group 2 for the initial treatment period is reported below. Up to 4 months
Secondary Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD], and Progressive Disease [PD])(Phase II Analysis Group 2 - Initial Treatment Period) The frequencies (and percentages) of tumor response categories (CR, PR, SD, PD) will be summarized for Phase II Analysis Group 2. Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to < 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion, b. At least a 20% increase in PBSD. c. PD via FDG-PET imaging. d. unequivocal progression of existing non-target lesions and non-target lymph nodes. e. symptomatic deterioration. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD. Up to 2 years
Secondary Duration of Response (Phase II Analysis Group 2 - Initial Treatment Period) Duration of response is defined as the time between each patient's best tumor response and progression (or date of last disease assessment for patients who die without progression or are lost to follow-up). Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to < 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD. Time between each patient's best tumor response and progression(or date of last disease assessment for patients who die without progression or are lost to follow-up), assessed up to 2 years
Secondary Number of Patients Having CR, PR, or SD at 6 Months (Phase II Analysis Group 2 - Initial Treatment Period) Will be defined as the number of patients having either complete response (CR), partial response (PR), or stable disease for at least 6 months after starting treatment. The frequencies and rates of tumor response categories (CR, PR, SD, PD, and too early/not evaluated) will be summarized by dose cohort and treatment arm. Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to < 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion,b. At least a 20% increase in PBSD. c. PD via FDG-PET imaging. d. unequivocal progression of existing non-target lesions and non-target lymph nodes. e. symptomatic deterioration. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD. Up to 6 months
Secondary Time to Progression (TTP) (Phase II Analysis Group 2 - Initial Treatment Period) Time to progression is defined as the time between randomization and disease progression. Kaplan-Meier methodology will be used to estimate the distribution of TTP. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion,b. At least a 20% increase in PBSD. c. PD via FDG-PET imaging. d. unequivocal progression of existing non-target lesions and non-target lymph nodes. e. Symptomatic deterioration. Time between randomization and disease progression, assessed up to 2 years
Secondary Overall Survival (OS) (Phase II Analysis Group 2 - Initial Treatment Period) Overall survival (OS) (Phase II Analysis Group 2 - Initial Treatment Period). Kaplan-Meier methodology will be used to estimate the distribution of OS. Time between randomization and death due to any cause (or last contact for surviving patients and those lost to follow-up), assessed up to 2 years
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