Testing Binimetinib as a Potential Targeted Treatment in Cancers With NRAS Genetic Changes (MATCH… (NCT04439344) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Testing Binimetinib as a Potential Targeted Treatment in Cancers With NRAS Genetic Changes (MATCH-Subprotocol Z1A)
United States53 participantsStarted 2016-05-31
Plain-language summary
This phase II MATCH treatment trial investigates the good and bad effects of binimetinib in patients whose cancer has a genetic change called NRAS mutation. Binimetinib blocks proteins called MEK1 and MEK2, which may be needed for cancer cell growth when an NRAS mutation is present. Researchers hope to learn if binimetinib will shrink this type of cancer or stop its growth.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol
* Patients must have NRAS mutation in codon 12, 13, 61 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 significant abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)
* Creatinine =\< 1.5 mg/dL, or calculated creatinine clearance (determined as per Cockcroft-Gault) \>= 50mL/min
* Patients must have adequate cardiac function:
* Left ventricular ejection fraction (LVEF) \>= 50% as determined by a multigated acquisition (MUGA) scan or echocardiogram,
* QTc interval =\< 480 ms
Exclusion Criteria:
* Patients must not have known hypersensitivity to binimetinib or compounds of similar chemical or biologic composition
* Patients with melanoma are excluded
* Patients must not have any active central nervous system (CNS) lesion (i.e., those with radiographically unstable, symptomatic lesions) and/or leptomeningeal metastases
* NOTE: Patients treated with stereotactic radiotherapy or surgery are eligible if the patient remained without evidence of CNS disease progression \>= 3 months. Patients must be off corticosteroid therapy for \>= 3 weeks
* Patients must not have a history or current evidence of retinal vein occlusion (RVO) or …
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration