Status:
ACTIVE_NOT_RECRUITING
Testing VS-6063 (Defactinib) as a Potential Targeted Treatment in Cancers With NF2 Genetic Changes (MATCH-Subprotocol U)
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II MATCH treatment trial identifies the effects of VS-6063 (defactinib) in patients whose cancer has a genetic change called NF2 mutation. Defactinib may block a protein called FAK, which m...
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. SECONDAR...
Eligibility Criteria
Inclusion
- Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol
- Patients must have a tumor that harbors an inactivating mutation in NF2
- 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 echocardiogram (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
- Patients with history of hypertension should be adequately controlled (blood pressure \[BP\] \< 140/90) with appropriate anti-hypertensive therapy or diet
Exclusion
- Patients must not have known hypersensitivity to VS-6063 (defactinib) or compounds of similar chemical or biologic composition
- Patients must not have a history of upper gastrointestinal (GI) bleeding, ulceration, or perforation within 12 months prior to the first dose of study drug
- Patients must not have known history of Gilbert's syndrome
- Patient must not have a known history of stroke or cerebrovascular accident within 6 months prior to the first dose of VS-6063 (defactinib)
- Patients must not have prior treatment with a FAK inhibitor (e.g., VS-6063 \[defactinib\] or GSK2256098) and must not be participating or have participated in the COMMAND trial of maintenance therapy of VS-6063 (defactinib) versus (vs.) placebo, for mesothelioma
- Patients must not be using drugs or foods that are known potent CYP3A4 or CYP2C9 inhibitors or inducers. Substrates of CYP3A4, 2C9, UGT1A1, P-gp, OATP1B1, and OATP1B3 should be used with caution
Key Trial Info
Start Date :
November 19 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04439331
Start Date
November 19 2015
End Date
December 31 2025
Last Update
November 19 2025
Active Locations (1)
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1
ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, United States, 19103