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)
- Conditions
- Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR MutationsMedDRA version: 21.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-005604-35-Outside-EU/EEA
- Lead Sponsor
- ational Cancer Institute (NCI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
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
Are the trial subjects under 18? yes
Number of subjects for this age range: 49
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 childbearing
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.
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 (See Section 4.1.6.1.d).
- 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.
- 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.
Infection: 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method