Children's Hospital of Alabama |
Birmingham, Alabama, United States, 35233 |
Contact: Site Public Contact 205-638-9285 oncologyresearch@peds.uab.edu |
Principal Investigator: Elizabeth D. Alva |
Providence Alaska Medical Center |
Anchorage, Alaska, United States, 99508 |
Contact: Site Public Contact 907-212-6871 AKPAMC.OncologyResearchSupport@providence.org |
Principal Investigator: Brenda J. Wittman |
Banner Children's at Desert |
Mesa, Arizona, United States, 85202 |
Contact: Site Public Contact 480-412-3100 |
Principal Investigator: Joseph C. Torkildson |
Banner University Medical Center - Tucson |
Tucson, Arizona, United States, 85719 |
Contact: Site Public Contact aselegue@email.arizona.edu |
Principal Investigator: Holly E. Pariury |
Arkansas Children's Hospital |
Little Rock, Arkansas, United States, 72202-3591 |
Contact: Site Public Contact 501-364-7373 |
Principal Investigator: David L. Becton |
Kaiser Permanente Downey Medical Center |
Downey, California, United States, 90242 |
Contact: Site Public Contact 626-564-3455 |
Principal Investigator: Robert M. Cooper |
Loma Linda University Medical Center |
Loma Linda, California, United States, 92354 |
Contact: Site Public Contact 909-558-4050 |
Principal Investigator: Albert Kheradpour |
Miller Children's and Women's Hospital Long Beach |
Long Beach, California, United States, 90806 |
Contact: Site Public Contact 562-933-5600 |
Principal Investigator: Jacqueline N. Casillas |
Children's Hospital Los Angeles |
Los Angeles, California, United States, 90027 |
Contact: Site Public Contact 323-361-4110 |
Principal Investigator: Fariba Navid |
Cedars Sinai Medical Center |
Los Angeles, California, United States, 90048 |
Contact: Site Public Contact 310-423-8965 |
Principal Investigator: Fataneh (Fae) Majlessipour |
Valley Children's Hospital |
Madera, California, United States, 93636 |
Contact: Site Public Contact 559-353-3000 Research@valleychildrens.org |
Principal Investigator: Karen S. Fernandez |
UCSF Benioff Children's Hospital Oakland |
Oakland, California, United States, 94609 |
Contact: Site Public Contact 510-428-3324 Carla.Golden@ucsf.edu |
Principal Investigator: Carla B. Golden |
Kaiser Permanente-Oakland |
Oakland, California, United States, 94611 |
Contact: Site Public Contact 877-642-4691 Kpoct@kp.org |
Principal Investigator: Laura A. Campbell |
UCSF Medical Center-Mission Bay |
San Francisco, California, United States, 94158 |
Contact: Site Public Contact 877-827-3222 |
Principal Investigator: Arun A. Rangaswami |
Children's Hospital Colorado |
Aurora, Colorado, United States, 80045 |
Contact: Site Public Contact 303-764-5056 josh.b.gordon@nsmtp.kp.org |
Principal Investigator: Margaret E. Macy |
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center |
Denver, Colorado, United States, 80218 |
Contact: Site Public Contact 303-839-6000 |
Principal Investigator: Jennifer J. Clark |
Yale University |
New Haven, Connecticut, United States, 06520 |
Contact: Site Public Contact 203-785-5702 canceranswers@yale.edu |
Principal Investigator: Nina S. Kadan-Lottick |
Alfred I duPont Hospital for Children |
Wilmington, Delaware, United States, 19803 |
Contact: Site Public Contact 302-651-6884 dperry@nemours.org |
Principal Investigator: Scott M. Bradfield |
Children's National Medical Center |
Washington, District of Columbia, United States, 20010 |
Contact: Site Public Contact 202-884-2549 |
Principal Investigator: Jeffrey S. Dome |
University of Florida Health Science Center - Gainesville |
Gainesville, Florida, United States, 32610 |
Contact: Site Public Contact 352-273-8010 cancer-center@ufl.edu |
Principal Investigator: William B. Slayton |
Memorial Regional Hospital/Joe DiMaggio Children's Hospital |
Hollywood, Florida, United States, 33021 |
Contact: Site Public Contact 954-265-1847 OHR@mhs.net |
Principal Investigator: Iftikhar Hanif |
Nemours Children's Clinic-Jacksonville |
Jacksonville, Florida, United States, 32207 |
Contact: Site Public Contact 904-697-3529 |
Principal Investigator: Scott M. Bradfield |
University of Miami Miller School of Medicine-Sylvester Cancer Center |
Miami, Florida, United States, 33136 |
Contact: Site Public Contact 305-243-2647 |
Principal Investigator: Julio C. Barredo |
Nicklaus Children's Hospital |
Miami, Florida, United States, 33155 |
Contact: Site Public Contact 888-624-2778 |
Principal Investigator: Enrique A. Escalon |
AdventHealth Orlando |
Orlando, Florida, United States, 32803 |
Contact: Site Public Contact 407-303-2090 FH.Cancer.Research@flhosp.org |
Principal Investigator: Fouad M. Hajjar |
Arnold Palmer Hospital for Children |
Orlando, Florida, United States, 32806 |
Contact: Site Public Contact 321-841-2008 melissa.leffin@orlandohealth.com |
Principal Investigator: Amy A. Smith |
Nemours Children's Hospital |
Orlando, Florida, United States, 32827 |
Contact: Site Public Contact 407-650-7715 |
Principal Investigator: Scott M. Bradfield |
Johns Hopkins All Children's Hospital |
Saint Petersburg, Florida, United States, 33701 |
Contact: Site Public Contact 727-767-4784 Ashley.Repp@jhmi.edu |
Principal Investigator: Stacie L. Stapleton |
Saint Joseph's Hospital/Children's Hospital-Tampa |
Tampa, Florida, United States, 33607 |
Contact: Site Public Contact 813-357-0849 jennifer.manns@baycare.org |
Principal Investigator: Don E. Eslin |
Saint Mary's Hospital |
West Palm Beach, Florida, United States, 33407 |
Contact: Site Public Contact 561-881-2815 |
Principal Investigator: Narayana Gowda |
Children's Healthcare of Atlanta - Egleston |
Atlanta, Georgia, United States, 30322 |
Contact: Site Public Contact 404-785-2025 Leann.Schilling@choa.org |
Principal Investigator: William T. Cash |
Saint Luke's Cancer Institute - Boise |
Boise, Idaho, United States, 83712 |
Contact: Site Public Contact 208-381-2774 eslinget@slhs.org |
Principal Investigator: Eugenia Chang |
Lurie Children's Hospital-Chicago |
Chicago, Illinois, United States, 60611 |
Contact: Site Public Contact 773-880-4562 |
Principal Investigator: David O. Walterhouse |
University of Chicago Comprehensive Cancer Center |
Chicago, Illinois, United States, 60637 |
Contact: Site Public Contact 773-702-8222 cancerclinicaltrials@bsd.uchicago.edu |
Principal Investigator: Susan L. Cohn |
Saint Jude Midwest Affiliate |
Peoria, Illinois, United States, 61637 |
Contact: Site Public Contact 888-226-4343 |
Principal Investigator: Jaime M. Libes |
Southern Illinois University School of Medicine |
Springfield, Illinois, United States, 62702 |
Riley Hospital for Children |
Indianapolis, Indiana, United States, 46202 |
Contact: Site Public Contact 800-248-1199 |
Principal Investigator: Sandeep Batra |
Saint Vincent Hospital and Health Care Center |
Indianapolis, Indiana, United States, 46260 |
Contact: Site Public Contact 317-338-2194 research@stvincent.org |
Principal Investigator: Bassem I. Razzouk |
Blank Children's Hospital |
Des Moines, Iowa, United States, 50309 |
Contact: Site Public Contact 515-241-8912 samantha.mallory@unitypoint.org |
Principal Investigator: Samantha L. Mallory |
University of Iowa/Holden Comprehensive Cancer Center |
Iowa City, Iowa, United States, 52242 |
Contact: Site Public Contact 800-237-1225 |
Principal Investigator: Mariko Sato |
University of Kentucky/Markey Cancer Center |
Lexington, Kentucky, United States, 40536 |
Contact: Site Public Contact 859-257-3379 |
Principal Investigator: James T. Badgett |
Norton Children's Hospital |
Louisville, Kentucky, United States, 40202 |
Contact: Site Public Contact 502-629-5500 CancerResource@nortonhealthcare.org |
Principal Investigator: Ashok B. Raj |
Children's Hospital New Orleans |
New Orleans, Louisiana, United States, 70118 |
Contact: Site Public Contact CHResearch@lcmchealth.org |
Principal Investigator: Lolie C. Yu |
Ochsner Medical Center Jefferson |
New Orleans, Louisiana, United States, 70121 |
Contact: Site Public Contact 504-703-8712 Gregory.Johnstone@ochsner.org |
Principal Investigator: Craig Lotterman |
Eastern Maine Medical Center |
Bangor, Maine, United States, 04401 |
Contact: Site Public Contact 207-973-4274 |
Principal Investigator: Nadine P. SantaCruz |
Sinai Hospital of Baltimore |
Baltimore, Maryland, United States, 21215 |
Contact: Site Public Contact 410-601-6120 pridgely@lifebridgehealth.org |
Principal Investigator: Jason M. Fixler |
Johns Hopkins University/Sidney Kimmel Cancer Center |
Baltimore, Maryland, United States, 21287 |
Contact: Site Public Contact 410-955-8804 jhcccro@jhmi.edu |
Principal Investigator: Kenneth J. Cohen |
C S Mott Children's Hospital |
Ann Arbor, Michigan, United States, 48109 |
Contact: Site Public Contact 800-865-1125 |
Principal Investigator: Rajen Mody |
Helen DeVos Children's Hospital at Spectrum Health |
July 6, 2017
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July 7, 2017
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June 9, 2021
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November 6, 2017
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December 31, 2024 (Final data collection date for primary outcome measure)
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Response rate [ Time Frame: 3 years ] Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method.
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Same as current
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- Incidence of adverse events [ Time Frame: Up to 3 years ]
Graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade. A patient will be counted only once for a given toxicity for the worst grade of that toxicity reported for that patient. Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen.
- Progression free survival (PFS) [ Time Frame: From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 3 years ]
PFS along with the confidence intervals will be estimated using the Kaplan-Meier method.
- Pharmacokinetic (PK) parameters [ Time Frame: Course 2 day 1 ]
A descriptive analysis of PK parameters will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
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- Incidence of adverse events graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 3 years ]
Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade. A patient will be counted only once for a given toxicity for the worst grade of that toxicity reported for that patient. Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen.
- Pharmacokinetic (PK) parameters [ Time Frame: Course 2 day 1 ]
A descriptive analysis of PK parameters will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
- Progression free survival (PFS) [ Time Frame: From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 3 years ]
PFS along with the confidence intervals will be estimated using the Kaplan-Meier method.
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Changes in tumor genomic profile [ Time Frame: Up to 3 years ] A descriptive analysis will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.
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Same as current
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Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)
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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
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This phase II Pediatric MATCH trial studies how well erdafitinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have spread to other places in the body and have come back or do not respond to treatment with FGFR mutations. Erdafitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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PRIMARY OBJECTIVES:
I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with JNJ-42756493 (erdafitinib) with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor genetic alterations in the FGFR1/2/3/4 pathway.
SECONDARY OBJECTIVES:
I. To estimate the progression free survival in pediatric patients treated with JNJ-42756493 (erdafitinib) with advanced solid tumors (including CNS tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor genetic alterations in the FGFR1/2/3/4.
II. To obtain information about the tolerability of JNJ-42756493 (erdafitinib) in children with relapsed or refractory cancer.
III. To provide preliminary estimates of the pharmacokinetics of JNJ-42756493 (erdafitinib) in children with relapsed or refractory cancer.
EXPLORATORY OBJECTIVES:
I. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA).
OUTLINE:
Patients receive erdafitinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
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Interventional
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Phase 2
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Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
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- Advanced Malignant Solid Neoplasm
- Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma
- Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma
- Low Grade Glioma
- Malignant Glioma
- Recurrent Childhood Ependymoma
- Recurrent Childhood Malignant Germ Cell Tumor
- Recurrent Childhood Medulloblastoma
- Recurrent Childhood Non-Hodgkin Lymphoma
- Recurrent Childhood Rhabdomyosarcoma
- Recurrent Childhood Soft Tissue Sarcoma
- Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Recurrent Hepatoblastoma
- Recurrent Langerhans Cell Histiocytosis
- Recurrent Malignant Solid Neoplasm
- Recurrent Neuroblastoma
- Recurrent Osteosarcoma
- Recurrent Primary Central Nervous System Neoplasm
- Refractory Langerhans Cell Histiocytosis
- Refractory Malignant Solid Neoplasm
- Refractory Neuroblastoma
- Refractory Non-Hodgkin Lymphoma
- Refractory Primary Central Nervous System Neoplasm
- Rhabdoid Tumor
- Stage III Soft Tissue Sarcoma AJCC v7
- Stage IV Soft Tissue Sarcoma AJCC v7
- Wilms Tumor
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- Drug: Erdafitinib
Given PO
- Other: Laboratory Biomarker Analysis
Correlative studies
- Other: Pharmacological Study
Correlative studies
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Experimental: Treatment (erdafitinib)
Patients receive erdafitinib PO QD on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Interventions:
- Drug: Erdafitinib
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
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Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review.
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Recruiting
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49
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Same as current
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December 31, 2024
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December 31, 2024 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
- Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to molecular analysis for therapy choice (MATCH) to APEC1621B based on the presence of an actionable mutation
- Patients must have a body surface area >= 0.53 m^2 at enrollment
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Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice
- Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
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Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
- Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
- Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent
- Antibodies: >= 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
- Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
- Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator
- Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
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Stem cell infusions (with or without total body irradiation [TBI]):
- Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
- Autologous stem cell infusion including boost infusion: >= 42 days
- Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)
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X-ray therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation
- Note: radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment
- Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 [131I-MIBG]): >= 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
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For patients with solid tumors without known bone marrow involvement:
- Peripheral absolute neutrophil count (ANC) >= 1000/mm^3
- Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
- Hemoglobin >= 8.0 g/dL at baseline (may receive red blood cell [RBC] transfusions)
- Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive platelet or packed [p]RBC transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity
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Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
- Age: 1 to < 2 years; maximum serum creatinine (mg/dL): male 0.6; female 0.6
- Age: 2 to < 6 years; maximum serum creatinine (mg/dL): male 0.8; female 0.8
- Age: 6 to < 10 years; maximum serum creatinine (mg/dL): male 1; female 1
- Age: 10 to < 13 years; maximum serum creatinine (mg/dL): male 1.2; female 1.2
- Age: 13 to < 16 years; maximum serum creatinine (mg/dL): male 1.5; female 1.4
- Age: >= 16 years; maximum serum creatinine (mg/dL): male 1.7; female 1.4
- Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L; (for the purpose of this study, the ULN for SGPT is 45 U/L)
- Serum albumin >= 2 g/dL
- Corrected QT (QTc) interval =< 480 milliseconds
- Pulse oximetry > 94% on room air if there is clinical indication for determination (e.g. dyspnea at rest)
- Patients must be able to swallow intact tablets
- All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Exclusion Criteria:
- Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal studies; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method, while receiving study treatment and for 3 months after the last dose of JNJ-42756493 (erdafitinib); male subjects (with a partner of child-bearing potential) must use a condom with spermicide when sexually active and must not donate sperm from the first dose of study drug until 5 months after the last dose of study drug
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Concomitant medications
- Corticosteroids: patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
- Investigational drugs: patients who are currently receiving another investigational drug are not eligible
- Anti-cancer agents: patients who are currently receiving other anti-cancer agents are not eligible
- Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
- CYP3A4 agents: patients who are currently receiving drugs that are strong inducers or inhibitors of CYP3A4 are not eligible; Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed
- CYP2C9 agents: patients who are currently receiving drugs that are moderate to strong inducers or inhibitor of CYP2C9 are not eligible
- P-glycoprotein: patients who are currently receiving drugs that are potent inhibitors of p-glycoprotein are not eligible
- Patients who have an uncontrolled infection are not eligible
- Patients who have received a prior solid organ transplantation are not eligible
- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
- A history of cardiovascular diseases: unstable angina, myocardial infarction, or known congestive heart failure class IIIV within the preceding 12 months; cerebrovascular accident or transient ischemic attack within the preceding 3 months, pulmonary embolism within the preceding 2 months
- A history of any of the following: sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, cardiac arrest, Mobitz II second degree heart block or third degree heart block; known presence of dilated, hypertrophic, or restrictive cardiomyopathy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- 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
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Sexes Eligible for Study: |
All |
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12 Months to 21 Years (Child, Adult)
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No
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Puerto Rico, United States
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|
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NCT03210714
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NCI-2017-01159 NCI-2017-01159 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) APEC1621B ( Other Identifier: Children's Oncology Group ) APEC1621B ( Other Identifier: CTEP ) U10CA180886 ( U.S. NIH Grant/Contract ) UM1CA081457 ( U.S. NIH Grant/Contract )
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No
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Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
|
Not Provided
|
National Cancer Institute (NCI)
|
National Cancer Institute (NCI)
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Not Provided
|
Principal Investigator: |
Alice Lee |
Children's Oncology Group |
|
National Cancer Institute (NCI)
|
April 2021
|