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Protocol No. APEC1621B

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 JNJ-42756493 (Erdafitinib) in Patients with Tumors Harboring FGFR1/2/3/4 Alterations

Objective
This is a Phase 2 study of a drug called JNJ-42756493 (erdafitinib). In a Phase 2 study, the goal is to find out what effects, good and/or bad, a drug has on tumors.
We are using JNJ-42756493 (erdafitinib) in this study because it has been shown to block the growth of cancer cells with changes (mutations) in the FGFR1/2/3/4 genes. These mutations help cancer cells grow in test tubes and in animals. To be eligible for this study tumors need a mutation in one of these genes. JNJ-42756493 (erdafitinib) is considered a study drug , we do not know if it will work against these tumors.
A Phase 1 study of JNJ-42756493 (erdafitinib) has been completed in adults with cancer. In the Phase 1 study, researchers determined the dose of JNJ-42756493 (erdafitinib) can be given without too many side effects. This study will be the first time that JNJ-42756494 (erdafitinib) is given to children. The dose used in this study will be based on the dose used in adults.

Treatment JNJ-42756493 (erdafitinib) will be given by mouth once daily for 28 days, for up to 2 years unless serious side effects or tumor worsens

Description Phase 2 Pediatric MATCH sub protocol of JNJ-42756493 (Erdafitinib) in Patients with Tumors Harboring FGFR1/2/3/4 Alterations

Key Eligibility
  • Patients must be ≥ than 12 months and ≤ 21 years of age
  • Patients must have a body surface area ≥ 0.53 m2
  • 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
  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy
  • ≥ 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
  • ≥ 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
  • If used to modify immune adverse events related to prior therapy, ≥ 14 days must have elapsed since last dose of corticosteroid
  • ≥ 14 days after the last dose of a longacting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor
  • ≥ 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
  • Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including DLI or boost infusion: ≥ 84 days after infusion and no evidence of GVHD
  • Autologous stem cell infusion including boost infusion: ≥ 42 days
  • ≥ 42 days after the completion of any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells, etc.)
  • ≥ 14 days after local XRT; ≥ 150 days after TBI, craniospinal XRT or if radiation to ≥ 50% of the pelvis; ≥ 42 days if other substantial BM radiation
  • ≥ 42 days after systemically administered radiopharmaceutical therapy
  • Patients must not have received prior exposure to JNJ-42756493 (erdafitinib) or another FGFR inhibitor such as (but not limited to) AZD4547, BGJ398, BAY1163877, LY2874455
  • Adequate bone marrow, liver, renal, cardiac and pulmonary function
  • Can not be pregnant or breastfeeding
  • Male and Female must use adequate birth control
  • Patients who have received a prior solid organ transplantation are not eligible
  • No significant ophthalmologic conditions

    • 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; Ill-Defined Sites; Kidney; 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