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Luciann Nguyen
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NCT04439344phase 2active not recruiting

Testing Binimetinib as a Potential Targeted Treatment in Cancers With NRAS Genetic Changes (MATCH-Subprotocol Z1A)

National Cancer Institute (NCI)

ClinicalTrials.gov
53
Enrollment · actual
1
Countries · 1 sites
2019-05
Primary completion
4 mo ago
Record updated
Commercial relevance

No explicit biomarker / molecular-testing language identified in the public record.

Biomarker requirement language
  • 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
Change timeline

No changes detected yet. The first refresh records a baseline snapshot; subsequent refreshes generate field-level changes.

Signals from this trial
  • New trial
    37/100
    Opportunity

    New phase 2 trial NCT04439344 posted by National Cancer Institute (NCI): "Testing Binimetinib as a Potential Targeted Treatment in Cancers With NRAS Genetic Changes (MATCH-Subprotocol Z1A)".

    ClinicalTrials.gov record updated 124 days ago.

Eligibility — raw, for validation
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 predisposing factors to RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes)
* Patients must not have a history of retinal degenerative disease
* Patients must not have a history of Gilbert's syndrome
* Patients must not have uncontrolled arterial hypertension despite medical treatment
* Patients must not have active hepatitis B, and/or active hepatitis C infection
* Patients must not have neuromuscular disorders that are associated with elevated creatine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
* Patients must not have impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)
* Patients who have received prior MEK inhibitors are excluded