Trial Title:
Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2)
NCT ID:
NCT06351371
Condition:
Malignant Solid Neoplasm
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo tumor biopsy
Arm group label:
Subprotocol K2 (FGFR mutation or fusion)
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Subprotocol K2 (FGFR mutation or fusion)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Subprotocol K2 (FGFR mutation or fusion)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Erdafitinib
Description:
Given orally
Arm group label:
Subprotocol K2 (FGFR mutation or fusion)
Other name:
Balversa
Other name:
JNJ 42756493
Other name:
JNJ-42756493
Other name:
JNJ42756493
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Subprotocol K2 (FGFR mutation or fusion)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Summary:
This phase II MATCH treatment trial tests how well erdafitinib (JNJ-42756493) works in
treating patients with tumors that have FGFR mutations or fusions. Erdafitinib is in a
class of medications called kinase inhibitors. It works by blocking the action of an
abnormal FGFR protein that signals cancer cells to multiply. This may help keep cancer
cells from growing and may kill them.
Detailed description:
PRIMARY OBJECTIVE:
I. To evaluate the proportion of patients with objective response (OR) to targeted study
agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.
SECONDARY OBJECTIVES:
I. To evaluate the proportion of patients alive and progression free at 6 months of
treatment with targeted study agent in patients with advanced refractory
cancers/lymphomas/multiple myeloma.
II. To evaluate time until death or disease progression. III. To identify potential
predictive biomarkers beyond the genomic alteration by which treatment is assigned or
resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and
imaging-based assessment platforms.
IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes
from pre- through post-therapy imaging can predict objective response and progression
free survival and to evaluate the association between pre-treatment radiomic phenotypes
and targeted gene mutation patterns of tumor biopsy specimens.
OUTLINE:
Patients receive erdafitinib orally (PO) once daily (QD) on days 1-28. Cycles repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
Additionally, patients undergo blood sample collection, computed tomography (CT), or
magnetic resonance imaging (MRI), and tumor biopsy throughout the study. (CLOSED TO
ACCRUAL 02/25/2022)
After completion of study treatment, patients are followed up every 3 months for 2 years
and then every 6 months for 1 year.
THE MATCH SCREENING TRIAL:
Please see NCT02465060 for information on the MATCH Screening Protocol and applicable
documents.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must have met applicable eligibility criteria in the Master MATCH Protocol
EAY131/ NCI-2015-00054 prior to registration to treatment subprotocol
- Patients must fulfill all eligibility criteria outlined in the MATCH Master Protocol
at the time of registration to treatment step (Step 1, 3, 5, 7)
- Patients must have FGFR mutation or fusion as determined via the MATCH Master
Protocol
- Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment
assignment and must have no clinically important abnormalities in rhythm, conduction
or morphology of resting ECG (e.g. complete left bundle branch block, third degree
heart block)
- Patients must not have known hypersensitivity to JNJ-42756493 (erdafitinib) or
compounds of similar chemical or biologic composition.
- Patients with current evidence of corneal or retinal disorder/keratopathy are
excluded
- Patients must not be currently using medications that can elevate serum phosphorous
and/or calcium levels
- Medications that increase serum calcium should be avoided. Over the counter
calcium supplements, antacids that contain calcium (Tums) and Vitamin D
supplements (cholecalciferol and ergocalciferol) should be avoided.
Prescription medications including lithium, hydrochlorothiazide and
chlorthalidone must be used with caution
- Medications that increase serum phosphate should be avoided. Over the counter
laxatives that contain phosphate such as Fleets Oral or Fleets enema and
Miralax should be avoided
- Patients with a history of hyperphosphatemia will be excluded
- Patients may not have received strong inhibitors or potent inducers of CYP3A within
2 weeks before the first dose of study treatment. Patients with inability to
discontinue treatment with a strong CYP3A4 and/or CYP2C9 inhibitor or inducer prior
to start of treatment are excluded
- Patients who have previously received treatment with a FGFR targeted inhibitor are
excluded. Such inhibitors include AZD4547, BGJ398, BAY1163877 and LY2874455). Prior
non-selective FGFR inhibitor treatment (e.g. Pazopanib, dovitinib, ponatinib,
brivanib, lucitanib, lenvatinib) are allowed
- Patients must not have any history of or current evidence of renal or endocrine
alterations of calcium/phosphate homeostasis, or history of or current evidence of
extensive tissue calcification (by evaluation of the clinician), including but not
limited to, the soft tissue, kidneys, intestine, myocardium and lung with the
exception of calcified lymph nodes and asymptomatic vascular calcification per
investigators' judgment
- Patients with transitional cell carcinoma of the bladder and /or urothelial tract
are not eligible. These patients are encouraged to enroll in the ongoing
disease-specific studies
- Patients with impaired renal function (glomerular filtration rate [GFR] < 60 mL/min)
are excluded. GFR should be assessed by direct measurement (i.e., creatinine
clearance or ethyldediaminetetraacetate) or, if not available, by calculation from
serum/plasma creatinine (Cockcroft-Gault formula)
- Patients with persistent phosphate level > ULN during screening (within 14 days of
treatment and prior to Cycle 1 Day 1) and despite medical management are excluded
- Patients with a history of or current uncontrolled cardiovascular disease as stated
below are excluded:
- Unstable angina, myocardial infarction, or known congestive heart failure Class
II-IV within the preceding 12 months; cerebrovascular accident or transient
ischemic attack within the preceding 3 months, pulmonary embolism within the
preceding 2 months • 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
- Patients with impaired wound healing capacity defined as skin/decubitus ulcers,
chronic leg ulcers, known gastric ulcers, or unhealed incisions are excluded
- Female subjects (of child-bearing potential and sexually active) must use medically
acceptable methods of birth control (hormonal or barrier method of birth control;
abstinence) prior to study entry, for the duration of the study, and for 4 months
after the last intake of study drug. 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
ECOG-ACRIN Cancer Research Group
Address:
City:
Philadelphia
Zip:
19103
Country:
United States
Start date:
July 3, 2018
Completion date:
December 31, 2025
Lead sponsor:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06351371
