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Protocol No. APEC1621F

Principal Investigator DeSantes, Kenneth

Phase II

Age Group Both

Scope National

Sponsor Type National

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

Objective This is a Phase 2 study of a drug called ensartinib. In a Phase 2 study, the goal is to find out what effects, good and/or bad, a drug has on your tumor or type of cancer. We are using ensartinib in this study because it has been shown to block the growth of cancer cells with mutations in ALK or ROS1 pathway genes in test tubes and in animals. Ensartinib is considered a study drug in the treatment of your tumor or type of cancer. You are eligible for this study because your tumor was found to have a mutation in this pathway. Although ensartinib has been given to a small number of adults, we do not know if it will work against the type of tumor you have

Treatment Ensartinib will be given by mouth once daily

Key Eligibility
  • Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to MATCH to APEC1621F based on the presence of an actionable mutation
  • Patients must be greater than or equal to 12 months and less than or equal to 21 years of age at the time of study enrollment
  • Patients must have a body surface area less than 0.5 m2 at enrollment
  • Patients must have radiographically measurable disease
  • Patients with neuroblastoma who do not have measurable disease but have MIBG+ evaluable disease are eligible
  • Karnofsky greater than or equal to 50% for patients greater than 16 years of age and Lansky greater than or equal to 50 for patients less than or equal to 16 years of age
  • Must have adequate Bone Marrow, Renal and Liver Function
  • Can not be pregnancy or Breast-Feeding
  • No uncontrolled infection
  • No prior solid organ transplantation

  • Applicable Disease Sites Anal; Any Site; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Hematologic cancers, other; Ill-Defined Sites; Kidney; Leukemia; Liver; Lung; Lymphoma; Melanoma/Skin cancer; Multiple Myeloma; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

    Status Open

    Participating Institutions Gundersen Health System; UW Hospital and Clinics