Trial Title:
Testing Sunitinib as Potentially Targeted Treatment in Cancers With cKIT Genetic Changes (MATCH - Subprotocol V)
NCT ID:
NCT06390826
Condition:
Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Refractory Lymphoma
Refractory Malignant Solid Neoplasm
Refractory Multiple Myeloma
Conditions: Official terms:
Lymphoma
Neoplasms
Multiple Myeloma
Sunitinib
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 biopsy
Arm group label:
Treatment (sunitinib)
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (sunitinib)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan
Arm group label:
Treatment (sunitinib)
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:
Procedure
Intervention name:
Echocardiography
Description:
Undergo ECHO
Arm group label:
Treatment (sunitinib)
Other name:
EC
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (sunitinib)
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
Intervention type:
Procedure
Intervention name:
Radionuclide Imaging
Description:
Undergo nuclear study
Arm group label:
Treatment (sunitinib)
Other name:
NM
Other name:
Nuclear Medicine
Other name:
nuclear medicine scan
Other name:
radioimaging
Other name:
Radionuclide Scanning
Other name:
Scan
Other name:
Scintigraphy
Intervention type:
Drug
Intervention name:
Sunitinib
Description:
Given PO
Arm group label:
Treatment (sunitinib)
Summary:
This phase II MATCH treatment trial tests how well sunitinib in treating patients with
cancer that has certain genetic changes. Sunitinib is in a class of medications called
kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in
the cKIT gene. It works by blocking the action of mutated cKIT that signals cancer cells
to multiply. This helps to stop or slow the spread of cancer cells.
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 sunitinib orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles
repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Additionally, patients undergo computed tomography (CT) or magnetic resonance imaging
(MRI) during screening and on study, as well as during follow-up as clinically necessary.
Patients also undergo echocardiography (ECHO) or nuclear study throughout the trial as
clinically necessary. Patients undergo biopsies and blood sample collection on study.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 1 year.
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 of MATCH Master Protocol at the time
of registration to treatment step (Step 1, 3, 5, 7)
- Patients must have a somatic cKIT mutation in exon 9, 11, 13 or 14, excluding exon
17 or 18 mutations, activating PDGFRA or PDGFRB variants and fusions, or another
aberration, as identified via the MATCH Master Protocol
- Actionable mutations of interest (aMOIs)for information on the inclusion and
exclusion mutations, along with the corresponding levels of evidence (LOE)
- Total bilirubin must be within normal institutional limits
- Creatinine must be within normal institutional limits. OR Creatinine clearance >= 60
mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- Serum calcium must be =< 12.0 mg/dL
- 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 with known left ventricular dysfunction must have ECHO or a nuclear study
(multigated acquisition scan [MUGA] or first pass) within 4 weeks prior to
registration to treatment and must not have left ventricular ejection fraction
(LVEF) < institutional lower limit of normal (LLN). If the LLN is not defined at a
site, the LVEF must be > 50% for the patient to be eligible.
- The following groups of patients are eligible provided they have New York Heart
Association class II cardiac function on baseline ECHO/nuclear study:
- Patients with a history of class II heart failure who are asymptomatic on
treatment
- Patients with prior anthracycline exposure
- Patients who have received central thoracic radiation that included the
heart in the radiotherapy port NOTE: Pre-treatment LVEF determination in
patients without known left ventricular dysfunction (or per Section
2.1.5.1) is NOT otherwise required
- Patients with any of the following conditions are excluded:
- Serious or non-healing wound, ulcer, or bone fracture
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 28 days of treatment
- Any history of cerebrovascular accident (CVA) or transient ischemic attack
within 12 months prior to study entry
- History of myocardial infarction, cardiac arrhythmia, stable/unstable angina,
symptomatic congestive heart failure, or coronary/peripheral artery bypass
graft or stenting within 12 months prior to study entry
- History of pulmonary embolism within the past 12 months
- Patients must not have known hypersensitivity or excess toxicity from sunitinib or
compounds of similar chemical composition or biologic effect. This list includes,
but is not limited to, patients with significant cardiac or hepatic toxicity from
multikinase inhibitors with similar kinase inhibitory profiles (sorafenib,
regorafenib, pazopanib)
- Questions regarding a significant intolerance to a prior therapy should be
directed to the sub-protocol principal investigator (PI)
- Patients must not have had prior therapy with sunitinib
- Patients must not have planned ongoing administration of STRONG and MODERATE CYP3A4
inhibitors or inducers. The reference list of cytochrome p450 (CYP) isozymes and
classification of strong, moderate, and weak interactions is available through the
FDA website
- Strong CYP3A4 inhibitors are not permitted within 7 days before dosing and
should be avoided throughout the study
- Strong CYP3A4 inducers are not permitted within 12 days before dosing and
should be avoided throughout the study
- Patients must not have gastrointestinal stromal tumor (GIST), renal cell carcinoma,
or pancreatic neuroendocrine tumor
- Patients must not have a National Cancer Institute Common Terminology Criteria for
Adverse Events (NCI CTCAE) version 4 grade 3 hemorrhage within 4 weeks of starting
study treatment
- Patients must not have hypertension that cannot be controlled by medications (>
140/90 mmHg despite optimal medical therapy)
- Patients must not have pre-existing thyroid abnormality with thyroid function that
cannot be maintained in the normal range with medication
- Participants may not have a major surgical procedure, open biopsy, or significant
traumatic injury within 28 days prior to starting sunitinib
- Patients with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive
neurologic dysfunction that would confound the evaluation of neurologic and other
adverse events
- Patients who require therapeutic doses of coumarin derivative anticoagulants such as
warfarin are excluded, although doses up to 2 mg daily are permitted for prophylaxis
of thrombosis NOTE: Low molecular weight heparin is permitted provided that the
patient's prothrombin time (PT) international normalized ratio (INR) is < 1.5
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:
August 11, 2015
Completion date:
March 24, 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/NCT06390826
