Clinical Trial Details
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NCT03210714 : Pediatric MATCH: Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations
PhasePhase 2
AgesMin: 12 Months Max: 21 Years
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

- 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

- Note: The following do not qualify as measurable disease:

- Malignant fluid collections (e.g., ascites, pleural effusions)

- Bone marrow infiltration except that detected by MIBG scan for neuroblastoma

- Lesions only detected by nuclear medicine studies (e.g., bone, gallium or
positron emission tomography [PET] scans) except as noted for neuroblastoma

- Elevated tumor markers in plasma or cerebrospinal fluid (CSF)

- Previously radiated lesions that have not demonstrated clear progression
post radiation

- Leptomeningeal lesions that do not meet the measurement requirements for
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

- 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

- 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)

- 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

- 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.)

- 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

- Patients must not have received prior exposure to JNJ-42756493 (erdafitinib) or
another FGFR inhibitor such as (but not limited to) AZD4547, BGJ398, BAY1163877,

- 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]

- 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

- 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

- 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; 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

- 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

- 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
LinksPermanent Link to THIS page:      |      Link to official listing
Washington, District of Columbia
Facility: Children's National Medical Center
Investigator: Jeffrey S. Dome
Contact: Jeffrey S. Dome
Click HERE to send email to this center

Orlando, Florida
Facility: Arnold Palmer Hospital for Children
Investigator: Vincent F. Giusti
Contact: Vincent F. Giusti Phone: 321-843-2584
Email not avaialable

Philadelphia, Pennsylvania
Facility: Childrens Oncology Group
Investigator: Donald W. Parsons
Contact: Donald W. Parsons
Click HERE to send email to this center

Pittsburgh, Pennsylvania
Facility: Children's Hospital of Pittsburgh of UPMC
Investigator: Jean M. Tersak
Contact: Jean M. Tersak
Click HERE to send email to this center

Milwaukee, Wisconsin
Facility: Children's Hospital of Wisconsin
Investigator: Paul D. Harker-Murray
Contact: Paul D. Harker-Murray Phone: 414-955-4727
Click HERE to send email to this center

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