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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.
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