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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05432791
Other study ID # NCI-2022-05065
Secondary ID NCI-2022-05065A0
Status Suspended
Phase Phase 2/Phase 3
First received
Last updated
Start date March 30, 2023
Est. completion date March 9, 2030

Study information

Verified date May 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II/III trial compares the effect of the combination treatment with olaparib and temozolomide to trabectedin or pazopanib (two of the most common chemotherapy drugs used as usual approach) in patients with uterine leiomyosarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) after initial chemotherapy has stopped working. The usual approach is defined as care most people get for advanced uterine leiomyosarcoma. Olaparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Temozolomide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. The combination of olaparib and temozolomide may work better than the usual treatment in shrinking or stabilizing advanced uterine leiomyosarcoma after initial chemotherapy has stopped working.


Description:

PRIMARY OBJECTIVES: I. To compare the progression free survival (PFS) of olaparib plus temozolomide (Arm 1) as compared to investigator's choice (trabectedin or pazopanib hydrochloride [pazopanib]) (Arm 2) for the treatment of patients with advanced uterine leiomyosarcoma (uLMS) who have received two or more prior lines of therapy as determined by investigator (local site) assessment. (Phase 2) II. To compare the overall survival (OS) of olaparib plus temozolomide (Arm 1) as compared to investigator's choice (trabectedin or pazopanib) (Arm 2) for the treatment of patients with advanced uLMS who have received two or more prior lines of therapy. (Phase 3) SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of each treatment by determining adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 5 and patient-reported toxicity using Patient-Reported Outcome (PRO)-CTCAE version 1 in and across each treatment arm. (Phase 2/3) II. To evaluate the objective response rate (ORR), duration of response (DOR) and disease control rate (DCR) in and across each treatment arm as determined by investigator assessment. (Phase 2/3) EXPLORATORY OBJECTIVE: I. To collect results of tumor genomic testing previously conducted as part of clinical care (when available) and (a) to determine the proportion of patients with a genomic alteration in a homologous recombination (HR) pathway gene and (b) to evaluate for any relationship between the presence of such an alteration and clinical benefit from olaparib and temozolomide. (Phase 2/3) OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients receive temozolomide orally (PO) once daily (QD) on days 1-7 of each cycle and olaparib PO twice daily (BID) on days 1-7 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) and/or bone scans throughout the trial. Patients also undergo collection of blood samples throughout the trial. ARM 2: Patients receive trabectedin intravenously (IV) continuously over 24 hours on day 1 of each cycle or pazopanib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and/or bone scans throughout the trial. Patients also undergo transthoracic echocardiography (TTE) or multi-gated acquisition scan (MUGA) on study and as clinically indicated, as well as collection of blood samples throughout the trial. After completion of study treatment, patients without disease progression are followed every 6 weeks until disease progression. After disease progression, patients are followed every 3 months for the first 2 years, then every 6 months thereafter until 5 years post-randomization or death, whichever comes first.


Other known NCT identifiers
  • NCT05633381

Recruitment information / eligibility

Status Suspended
Enrollment 190
Est. completion date March 9, 2030
Est. primary completion date March 9, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically confirmed leiomyosarcoma of uterine origin, as established by the site institutional practice for pathology confirmation for research studies when enrolling the patient on study. Central pathology review will not occur. - Metastatic or locally advanced and surgically unresectable disease, in the opinion of the treating investigator. - Patients must have at least one lesion that is measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria to be eligible for the study. - Not pregnant and not nursing, because this study involves agents that have 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 - Age >= 18 years. - Eastern Cooperative Oncology Group (ECOG) Performance Status =< 2. - Patients must have had prior progression on, or intolerance to, at least two prior lines of systemic therapy for advanced uLMS, one of which was an anthracycline (anthracycline monotherapy or combination). Adjuvant chemotherapy will qualify as a prior line of treatment. Endocrine treatment will not qualify as a prior line of treatment. - Patients may not have received prior treatment with any PARP inhibitor, temozolomide or dacarbazine (IV analogue of temozolomide). - Patients may not have had prior treatment with BOTH of the agents included on the investigator's choice arm: trabectedin AND pazopanib. If the patient has had prior treatment with one of these agents, they are eligible; however, they must be assigned to the other agent for investigator's choice. That is, patients who have received prior pazopanib must be assigned to trabectedin, and patients who have received prior trabectedin must be assigned to pazopanib. - Patients must have recovered to baseline or =< grade 1 per CTCAE version 5.0 from toxicity related to any prior treatment, unless adverse events are clinically nonsignificant and/or stable on supportive therapy, with the exception of fatigue (which must be =< grade 2), alopecia and/or endocrinopathies related to prior immunotherapy which are controlled with hormone replacement. - Patients must have completed all prior anti-cancer treatment, including radiation, >= 28 days prior to registration. - Patients may have undergone major surgery (related or unrelated to their cancer diagnosis) >= 28 days of registration. Subjects with clinically relevant ongoing complications from prior surgery are not eligible. - Absolute neutrophil count (ANC) >= 1500/mm^3 (within =< 28 days prior to registration). - Platelet count >= 100,000/mm^3 (within =< 28 days prior to registration). - Creatinine =< 1.5 * upper limit of normal (ULN) (within =< 28 days prior to registration). - If creatinine > 1.5 * ULN, then creatinine clearance (CrCl) must be > 50 mL/min, per Cockcroft-Gault method. - Hemoglobin >= 9 g/dL (within =< 28 days prior to registration). - No transfusions =< 14 days before cycle 1 day 1 (C1D1). - Total bilirubin =< 1.5 x ULN (within =< 28 days prior to registration). - If documented Gilbert's: =< 2.0 x ULN. - Aspartate aminotransferase/alanine aminotransferase (AST/ALT) =< 3 x ULN (within =< 28 days prior to registration). - Patients may not have uncontrolled hypertension defined as a blood pressure (BP) > 150/90 on two consecutive assessments during the screening period. If a patient is found to have a BP > 150/90 on two consecutive assessments during the screening period, the patient may be started on an anti-hypertensive regimen, and will be considered eligible if two subsequent measurements are performed and the BP is =< 150/90. If BP is in range on the first measurement, no further measurements are needed. - Patients must demonstrate a QTcF (Fredericia formula) =< 470 msec on an electrocardiography (EKG) performed during screening. This criterion applies only to patients who will receive pazopanib if randomized to Arm 2. Repeat EKG testing during the screening period is allowed. - Patients may not have an uncontrolled ventricular arrhythmia or recent (within 3 months) myocardial infarction. - In addition to the above, patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible, patients should be class 2B or better. - Patients may not have a history of active or unresolved: perforation, abscess or fistula within 28 days prior to registration (either clinically or radiographically). - Patients must not have myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or a history of bone marrow biopsy findings at any time consistent with MDS and/or AML. - For patients with evidence of chronic hepatitis B (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. - Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. - HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. - Patients with central nervous system (CNS)/leptomeningeal disease must have undergone definitive treatment, have no evidence of CNS progression on follow-up imaging performed at least 4 weeks after the CNS-directed therapy is completed, and be off all steroids, in order to be eligible. - Patients must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any other condition that would limit compliance with study requirements. - Patients must be able to swallow oral medications. - Patients may not require concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks. - Patients may not require concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents. - In order to complete the mandatory patient-completed measure, participants must be able to speak and/or read English and Spanish. Non-English or non-Spanish readers may still participate in the study but are not required to complete the PRO-CTCAE side effect surveys. - For all patients, prior to randomization and as part of eligibility, the investigator must select the agent which the patient would receive if assigned to the investigator's choice arm, prior to randomization. The patient must meet all eligibility criteria for that agent during screening and prior to randomization. - Patients without central venous access must be willing to undergo placement of central venous access (i.e. port or peripherally inserted central catheter [PICC] line, per institutional practice) if assigned to the investigator's choice arm and if the investigator intends to treat the patient with trabectedin. The site must be able to place central venous access within 10 days of registration/randomization.

Study Design


Related Conditions & MeSH terms

  • Leiomyosarcoma
  • Stage III Uterine Corpus Leiomyosarcoma AJCC v8
  • Stage IV Uterine Corpus Leiomyosarcoma AJCC v8

Intervention

Procedure:
Biospecimen Collection
Undergo collection of blood samples
Bone Scan
Undergo bone scan
Computed Tomography
Undergo CT scan
Magnetic Resonance Imaging
Undergo MRI
Multigated Acquisition Scan
Undergo MUGA
Drug:
Olaparib
Given PO
Pazopanib
Given PO
Temozolomide
Given PO
Trabectedin
Given IV
Procedure:
Transthoracic Echocardiography
Undergo TTE

Locations

Country Name City State
Puerto Rico Centro Comprensivo de Cancer de UPR San Juan
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic - Ames Ames Iowa
United States Alaska Women's Cancer Care Anchorage Alaska
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States UCHealth University of Colorado Hospital Aurora Colorado
United States UH Seidman Cancer Center at UH Avon Health Center Avon Ohio
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Our Lady of the Lake Medical Oncology Baton Rouge Louisiana
United States Bronson Battle Creek Battle Creek Michigan
United States UHHS-Chagrin Highlands Medical Center Beachwood Ohio
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Saint Joseph's/Candler - Bluffton Campus Bluffton South Carolina
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States McFarland Clinic - Boone Boone Iowa
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States West Virginia University Charleston Division Charleston West Virginia
United States Northwestern University Chicago Illinois
United States University of Illinois Chicago Illinois
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Memorial Hospital North Colorado Springs Colorado
United States UCHealth Memorial Hospital Central Colorado Springs Colorado
United States Memorial Sloan Kettering Commack Commack New York
United States Mercy Hospital Coon Rapids Minnesota
United States Heartland Oncology and Hematology LLP Council Bluffs Iowa
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States Carle at The Riverfront Danville Illinois
United States UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida
United States Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois
United States Smilow Cancer Hospital-Derby Care Center Derby Connecticut
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States City of Hope Comprehensive Cancer Center Duarte California
United States Epic Care-Dublin Dublin California
United States Duke University Medical Center Durham North Carolina
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Carle Physician Group-Effingham Effingham Illinois
United States Epic Care Partners in Cancer Care Emeryville California
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Smilow Cancer Hospital Care Center-Fairfield Fairfield Connecticut
United States Cancer Care and Hematology-Fort Collins Fort Collins Colorado
United States Poudre Valley Hospital Fort Collins Colorado
United States McFarland Clinic - Trinity Cancer Center Fort Dodge Iowa
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States Smilow Cancer Hospital Care Center at Glastonbury Glastonbury Connecticut
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan
United States Trinity Health Grand Rapids Hospital Grand Rapids Michigan
United States UCHealth Greeley Hospital Greeley Colorado
United States ECU Health Medical Center Greenville North Carolina
United States Smilow Cancer Hospital Care Center at Greenwich Greenwich Connecticut
United States Legacy Mount Hood Medical Center Gresham Oregon
United States Smilow Cancer Hospital Care Center - Guilford Guilford Connecticut
United States Memorial Sloan Kettering Westchester Harrison New York
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States City of Hope at Irvine Lennar Irvine California
United States Mayo Clinic in Florida Jacksonville Florida
United States McFarland Clinic - Jefferson Jefferson Iowa
United States Ascension Borgess Cancer Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Northwestern Medicine Lake Forest Hospital Lake Forest Illinois
United States Northwell Health/Center for Advanced Medicine Lake Success New York
United States Baptist Health Lexington Lexington Kentucky
United States Medical Center of the Rockies Loveland Colorado
United States McFarland Clinic - Marshalltown Marshalltown Iowa
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Contra Costa Regional Medical Center Martinez California
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Trinity Health Muskegon Hospital Muskegon Michigan
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States Yale University New Haven Connecticut
United States University Medical Center New Orleans New Orleans Louisiana
United States Memorial Sloan Kettering Cancer Center New York New York
United States Providence Newberg Medical Center Newberg Oregon
United States Yale-New Haven Hospital North Haven Medical Center North Haven Connecticut
United States Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores Michigan
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Nebraska Cancer Specialists/Oncology Hematology West PC - MECC Omaha Nebraska
United States Nebraska Methodist Hospital Omaha Nebraska
United States Oncology Associates PC Omaha Nebraska
United States Providence Willamette Falls Medical Center Oregon City Oregon
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Mayo Clinic Hospital in Arizona Phoenix Arizona
United States UM Sylvester Comprehensive Cancer Center at Plantation Plantation Florida
United States Legacy Good Samaritan Hospital and Medical Center Portland Oregon
United States Oregon Health and Science University Portland Oregon
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Women and Infants Hospital Providence Rhode Island
United States Corewell Health Reed City Hospital Reed City Michigan
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States VCU Massey Cancer Center at Stony Point Richmond Virginia
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Mayo Clinic in Rochester Rochester Minnesota
United States Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph Michigan
United States Mercy Hospital Saint Louis 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 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Maine Medical Center- Scarborough Campus Scarborough Maine
United States FHCC South Lake Union Seattle Washington
United States Fred Hutchinson Cancer Center Seattle Washington
United States University of Washington Medical Center - Montlake Seattle Washington
United States Smilow Cancer Hospital Care Center at Long Ridge Stamford Connecticut
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Smilow Cancer Hospital-Torrington Care Center Torrington Connecticut
United States Munson Medical Center Traverse City Michigan
United States Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut
United States Legacy Meridian Park Hospital Tualatin Oregon
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States Memorial Sloan Kettering Nassau Uniondale New York
United States Carle Cancer Center Urbana Illinois
United States Legacy Cancer Institute Medical Oncology and Day Treatment Vancouver Washington
United States Legacy Salmon Creek Hospital Vancouver Washington
United States Epic Care Cyberknife Center Walnut Creek California
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States MedStar Washington Hospital Center Washington District of Columbia
United States Smilow Cancer Hospital-Waterbury Care Center Waterbury Connecticut
United States Smilow Cancer Hospital Care Center - Waterford Waterford Connecticut
United States Smilow Cancer Hospital Care Center - Westerly Westerly Rhode Island
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Asplundh Cancer Pavilion Willow Grove Pennsylvania
United States University of Michigan Health - West Wyoming Michigan

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Other Proportion of patients with a genomic alteration in a homologous recombination (HR) pathway gene Will collect results of next generation sequencing that is known to the treating investigator and was previously performed as part of the patient's clinical care, for all patients registered to the study. Will evaluate for genomic alterations in HR pathway genes. A genomic alteration is defined as a homozygous deletion or deleterious (loss-of-function) mutation in any of the pre-defined HR pathway genes. Within 60 days of registration
Other Relationship between the presence of an alteration in HR pathway genes and clinical benefit from olaparib and temozolomide Will evaluate whether patients with an HR pathway alteration experience increased clinical benefit from olaparib and temozolomide as compared patients who lack such an alteration, as determined by objective response rate, progression-free survival and overall survival. Response rates will be compared using the Fisher's exact test, and time to event endpoints summarized using the Kaplan-Meier curves and the log-rank test. Assessed up to 5 years
Primary Progression free survival (PFS) (Phase II) Will be estimated using the Kaplan-Meier method, where the stratified log-rank test will be used to compare the distributions across the treatment arms. PFS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals. Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be assessed as well. Time between the date of randomization and the earliest of disease progression or death, assessed up to 5 years
Primary Overall survival (OS) (Phase III) Will be estimated using the Kaplan-Meier method, where the stratified log-rank test will be used to compare the distributions across the treatment arms. OS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals. Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be assessed as well. Time between the date of randomization and the date of death from any cause, assessed up to 5 years
Secondary Overall response rate Will be estimated by dividing the number of evaluable patients that achieve a confirmed response (partial response [PR] or better) by the total number of evaluable patients. This estimate will be calculated by arm and will also include a 95% confidence interval using the properties of the binomial distribution, and compared between the arms using a chi-square test. Up to 5 years
Secondary Duration of response (DOR) This analysis is restricted to those patients that achieved a confirmed response (PR or better). Patients that go off of study treatment prior to progression will have their DOR time censored at that time. Time from first evidence of response until disease progression (or death), assessed up to 5 years
Secondary Disease control rate Will be estimated using the number of patients that achieve complete response, partial response, or stable disease at the 6 week assessment divided by all evaluable patients. This estimate will be calculated by arm and will also include a 95% confidence interval using the properties of the binomial distribution, and compared between the arms using a chi-square test. Up to 6 weeks
Secondary Incidence of adverse events Adverse events will be recorded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for each patient. Frequency tables and summary statistics will be used and with the appropriate methods of evaluating categorical and continuous data. In addition, patient reported safety and tolerability will be assessed using Patient-Reported Outcomes (PRO)-CTCAE for a prespecified group of expected toxicities. PRO-CTCAE assessments will occur prior to registration and on day 1 of every cycle during treatment. Collection of PRO-CTCAE will be discontinued after cycle 11. Up to 4 weeks after the end of study treatment
See also
  Status Clinical Trial Phase
Terminated NCT02601209 - Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma Phase 1/Phase 2
Recruiting NCT05633381 - Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working Phase 2/Phase 3
Active, not recruiting NCT04200443 - Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma Phase 2
Active, not recruiting NCT03880019 - A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma Phase 2