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Protocol No. APEC1621J

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 BVD-523FB (ulixerlinib) in Patients with Tumors Harboring Activating MAPK Pathway Mutations

The main goal is to test any good and bad effects of the study drug BVD-523FB(ulixertinib) on your tumor
A second goal of the study is to evaluate side effects that might be caused by BVD523FB (ulixertinib), which could shrink your cancer but it could also cause side effects
To learn more about the pharmacology (how your body handles the drug) of BVD523FB(ulixertinib)

Treatment BVD-523FB (ulixertinib) will be given by mouth twice a day for 28 days. This entire 4 week period is called a cycle. You may continue to receive BVD-523FB (ulixertinib) for up to 2 years unless you develop serious side effects or your tumor worsens

Description Phase 2 Pediatric MATCH sub protocol of Ulixerlinib tumors with activating MAPK pathway mutations

Key Eligibility
  • APEC1621SC: Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to MATCH to APEC1621J 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 greater than or equal to 0.54 m2 at the time of study 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
  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet protocol defined minimum duration from prior anti-cancer directed therapy prior to enrollment
  • Patients must not have received prior exposure to BVD-523FB (ulixertinib) or other ERK inhibitors
  • Adequate Bone Marrow, Renal, Liver and Cardiac Function as described by the protocol
  • Patients must be able to swallow intact capsules
  • Can not be pregnant or breastfeeding
  • Patients who have an uncontrolled infection are not eligibile
  • Patients who have received a prior solid organ transplantation are not eligible
  • Patients with known significant ophthalmologic conditions (uncontrolled glaucoma, history of retinal vein occlusion or retinal detachment, excluding patients with longstanding findings secondary to existing conditions) are not eligible

  • Applicable Disease Sites Anal; 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