Malignant Solid Neoplasm Clinical Trial
Official title:
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 Subprotocol of Ensartinib in Patients With Tumors Harboring ALK or ROS1 Genomic Alterations
Verified date | March 2024 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II Pediatric MATCH trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back (recurrent) or does not respond to treatment (refractory) and may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Status | Recruiting |
Enrollment | 98 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Months to 21 Years |
Eligibility | Inclusion Criteria: - Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to Molecular Analysis for Therapy Choice (MATCH) to APEC1621F based on the presence of an actionable mutation - Patients must be >= than 12 months and =< 21 years of age at the time of study enrollment. - Patients must have a body surface area >= 0.5 m^2 at enrollment - Patients must have radiographically measurable disease at the time of study enrollment. Patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on a standard MRI or CT - Note: The following do not qualify as measurable disease: - Malignant fluid collections (e.g., ascites, pleural effusions) - Bone marrow infiltration except that detected by MIBG scan for neuroblastoma - Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma - Elevated tumor markers in plasma or cerebrospinal fluid (CSF) - Previously radiated lesions that have not demonstrated clear progression post radiation - Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 - Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age - Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score - Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately - Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea) - Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts [ANC] counts): >= 7 days after the last dose of agent - Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1 - Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid - Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator - Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors) - Stem cell Infusions (with or without total body irradiation [TBI]): - Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD) - Autologous stem cell infusion including boost infusion: >= 42 days - Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.) - Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial none marrow (BM) radiation - Note: Radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment - Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy - Patients must not have received prior exposure to ensartinib; prior treatment with other ALK inhibitors is permitted given that at least 5 half-lives or 21 days have elapsed since therapy discontinuation, whichever is greater - For patients with solid tumors without known bone marrow involvement: - Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 (within 7 days prior to enrollment) - Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (within 7 days prior to enrollment) - Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 (within 7 days prior to enrollment) or a serum creatinine based on age/gender as follows (within 7 days prior to enrollment): - Age 1 to < 2 years: maximum serum creatinine 0.6 mg/dL for male and 0.6 mg/dL for female - Age 2 to < 6 years: maximum serum creatinine 0.8 mg/dL for male and 0.8 mg/dL for female - Age 6 to < 10 years: maximum serum creatinine 1 mg/dL for male and 1 mg/dL for female - Age 10 to < 13 years: maximum serum creatinine 1.2 mg/dL for male and 1.2 mg/dL for female - Age 13 to < 16 years: maximum serum creatinine 1.5 mg/dL for male and 1.4 mg/dL for female - Age >= 16 years: maximum serum creatinine 1.7 mg/dL for male and 1.4 mg/dL for female - Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) - Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (within 7 days prior to enrollment) (for the purpose of this study, the ULN for SGPT is 45 U/L) - Serum albumin >= 2 g/dL (within 7 days prior to enrollment) - Patients must be able to swallow intact capsules - All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines Exclusion Criteria: - Pregnant or breast-feeding women will not be entered on this study because there is currently no available information regarding human fetal or teratogenic toxicities; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study treatment and for one week after the last dose of ensartinib - Concomitant medications - Corticosteroids: patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid - Investigational drugs: patients who are currently receiving another investigational drug are not eligible - Anti-cancer agents: patients who are currently receiving other anti-cancer agents are not eligible - Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial - CYP3A4 agents: patients who are currently receiving drugs that are strong inducers or strong inhibitors of CYP3A4 are not eligible; strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study - Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed - Patients who have an uncontrolled infection are not eligible - Patients who have received a prior solid organ transplantation are not eligible - Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible |
Country | Name | City | State |
---|---|---|---|
Australia | Perth Children's Hospital | Perth | Western Australia |
Puerto Rico | San Jorge Children's Hospital | San Juan | |
Puerto Rico | University Pediatric Hospital | San Juan | |
United States | Albany Medical Center | Albany | New York |
United States | Providence Alaska Medical Center | Anchorage | Alaska |
United States | C S Mott Children's Hospital | Ann Arbor | Michigan |
United States | Mission Hospital | Asheville | North Carolina |
United States | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia |
United States | Children's Hospital Colorado | Aurora | Colorado |
United States | Dell Children's Medical Center of Central Texas | Austin | Texas |
United States | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland |
United States | Eastern Maine Medical Center | Bangor | Maine |
United States | Children's Hospital of Alabama | Birmingham | Alabama |
United States | Saint Luke's Cancer Institute - Boise | Boise | Idaho |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
United States | Montefiore Medical Center - Moses Campus | Bronx | New York |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | University of Vermont and State Agricultural College | Burlington | Vermont |
United States | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina |
United States | Novant Health Presbyterian Medical Center | Charlotte | North Carolina |
United States | Lurie Children's Hospital-Chicago | Chicago | Illinois |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Rainbow Babies and Childrens Hospital | Cleveland | Ohio |
United States | Prisma Health Richland Hospital | Columbia | South Carolina |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | Medical City Dallas Hospital | Dallas | Texas |
United States | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Dayton Children's Hospital | Dayton | Ohio |
United States | Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado |
United States | Blank Children's Hospital | Des Moines | Iowa |
United States | Kaiser Permanente Downey Medical Center | Downey | California |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Michigan State University Clinical Center | East Lansing | Michigan |
United States | Sanford Broadway Medical Center | Fargo | North Dakota |
United States | Cook Children's Medical Center | Fort Worth | Texas |
United States | University of Florida Health Science Center - Gainesville | Gainesville | Florida |
United States | Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital | Grand Rapids | Michigan |
United States | BI-LO Charities Children's Cancer Center | Greenville | South Carolina |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas |
United States | M D Anderson Cancer Center | Houston | Texas |
United States | Riley Hospital for Children | Indianapolis | Indiana |
United States | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Nemours Children's Clinic-Jacksonville | Jacksonville | Florida |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | Children's Mercy Hospitals and Clinics | Kansas City | Missouri |
United States | East Tennessee Childrens Hospital | Knoxville | Tennessee |
United States | Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada |
United States | Summerlin Hospital Medical Center | Las Vegas | Nevada |
United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
United States | Arkansas Children's Hospital | Little Rock | Arkansas |
United States | Loma Linda University Medical Center | Loma Linda | California |
United States | Miller Children's and Women's Hospital Long Beach | Long Beach | California |
United States | Children's Hospital Los Angeles | Los Angeles | California |
United States | Norton Children's Hospital | Louisville | Kentucky |
United States | Valley Children's Hospital | Madera | California |
United States | University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin |
United States | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin |
United States | Saint Jude Children's Research Hospital | Memphis | Tennessee |
United States | Banner Children's at Desert | Mesa | Arizona |
United States | Nicklaus Children's Hospital | Miami | Florida |
United States | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida |
United States | Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
United States | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota |
United States | University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota |
United States | West Virginia University Healthcare | Morgantown | West Virginia |
United States | Morristown Medical Center | Morristown | New Jersey |
United States | The Children's Hospital at TriStar Centennial | Nashville | Tennessee |
United States | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee |
United States | Saint Peter's University Hospital | New Brunswick | New Jersey |
United States | Yale University | New Haven | Connecticut |
United States | The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York |
United States | Children's Hospital New Orleans | 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 | NYP/Weill Cornell Medical Center | New York | New York |
United States | Children's Hospital of The King's Daughters | Norfolk | Virginia |
United States | Kaiser Permanente-Oakland | Oakland | California |
United States | UCSF Benioff Children's Hospital Oakland | Oakland | California |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Children's Hospital and Medical Center of Omaha | Omaha | Nebraska |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Children's Hospital of Orange County | Orange | California |
United States | AdventHealth Orlando | Orlando | Florida |
United States | Arnold Palmer Hospital for Children | Orlando | Florida |
United States | Nemours Children's Hospital | Orlando | Florida |
United States | Nemours Children's Clinic - Pensacola | Pensacola | Florida |
United States | Saint Jude Midwest Affiliate | Peoria | Illinois |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
United States | Legacy Emanuel Children's Hospital | Portland | Oregon |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
United States | University of Rochester | Rochester | New York |
United States | University of California Davis Comprehensive Cancer Center | Sacramento | California |
United States | Cardinal Glennon Children's Medical Center | Saint Louis | Missouri |
United States | Mercy Hospital Saint Louis | Saint Louis | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Johns Hopkins All Children's Hospital | Saint Petersburg | Florida |
United States | Primary Children's Hospital | Salt Lake City | Utah |
United States | Children's Hospital of San Antonio | San Antonio | Texas |
United States | Methodist Children's Hospital of South Texas | San Antonio | Texas |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | UCSF Medical Center-Mission Bay | San Francisco | California |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota |
United States | Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington |
United States | Southern Illinois University School of Medicine | Springfield | Illinois |
United States | State University of New York Upstate Medical University | Syracuse | New York |
United States | Madigan Army Medical Center | Tacoma | Washington |
United States | Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida |
United States | ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo | Ohio |
United States | Banner University Medical Center - Tucson | Tucson | Arizona |
United States | New York Medical College | Valhalla | New York |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | Alfred I duPont Hospital for Children | Wilmington | Delaware |
United States | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) | Children's Oncology Group |
United States, Australia, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Biomarkers as predictors of response to ensartinib | Descriptive analysis will be performed and will be summarized with simple summary statistics. | Up to 4 years | |
Other | Changes in tumor genomic profile | Approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid will be explored. Descriptive analysis will be performed and will be summarized with simple summary statistics. | Up to 4 years | |
Primary | Objective response rate | A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method. | From enrollment to the end of treatment, up to 2 years | |
Secondary | Percentage of patients experiencing grade 3 or higher adverse events | Percentage of patients experiencing grade 3 or higher adverse events will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All patients who receive at least one dose of protocol therapy will be considered in the evaluation of toxicity. | From enrollment to the end of treatment, up to 2 years | |
Secondary | Progression free survival (PFS) | Progression free survival will be defined as time from the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause. PFS along with the confidence intervals will be estimated using the Kaplan-Meier method. | From the initiation of protocol treatment to the occurrence of disease progression or disease recurrence or death from any cause, assessed up to 5 years | |
Secondary | Pharmacokinetic (PK) parameters | A descriptive analysis of PK parameters will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit). | Pre-dose, 1, 2, 4, 6-8, and 20-24 hours post day 1 dose and pre-dose, 1, 2, 4, and 6-8 hours post day 28 dose of cycle 1 |
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