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Protocol No. APEC1621H

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 Olaparib in Patients with Tumors Harboring Defects in DNA Damage Repair Genes.

Objective This is a Phase 2 study of a drug called olaparib. 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 olaparib in this study because it has been shown to block the growth of cancer cells that have mutations in an important signaling pathway (called the DDR [DNA damage repair] pathway) in laboratory experiments and has reduced tumor size in some patients in clinical studies. You are eligible for this study because your tumor was found to have a mutation in this pathway. Genes in this pathway are frequently mutated in many types of cancers. You are eligible for this study because your tumor was found to have a mutation in one of these genes.

Treatment Olaparib tablets will be given by mouth twice daily

Key Eligibility
  • Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to MATCH to APEC1621H 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 ≥ 0.65 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 ≥ 50% for patients > 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age
  • Must have adequate Bone Marrow, renal and liver function
  • Must have adequate Coagulation
  • Can not be pregnancy or breast-feeding
  • No uncontrolled infection
  • No prior serologically positive for human immunodeficiency virus (HIV)
  • No known active hepatitis
  • No prior solid organ transplantation
  • No symptomatic uncontrolled brain metastases
  • Patients with known symptomatic Fanconi Anemia (FA), Ataxia-telangiectasia (A-T) Syndrome, Bloom syndrome (BS) and Nijmegen breakage syndrome (NBS) are not eligible (Asymptomatic carriers are acceptable)

  • 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