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Last Updated: January 25, 2022

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CLINICAL TRIALS PROFILE FOR BINIMETINIB

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All Clinical Trials for Binimetinib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01562899 ↗ A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors Terminated Array BioPharma Phase 1/Phase 2 2012-08-27 This is a multi-center, open-label, phase Ib/II study. First, the aim of the phase Ib part is to estimate the MTD(s) and/or to identify the recommended phase II dose(s) (RP2D) for the combination of MEK162 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. The dose escalation part of the study will be guided by a Bayesian Logistic Regression Model (BLRM). At least 18 patients are expected to be enrolled in the dose escalation part. Following MTD/ RP2D declaration, patients will be enrolled in three phase II arms to assess efficacy of the combination as well as to better understand the safety, tolerability, PK, antibody concentrations and PD of the combination at MTD/RP2D. Phase II arm 1 will consist of approximately 25 patients with KRAS-mutant colorectal adenocarcinoma. Phase II arm 2 will consist of approximately 20 patients with metastatic pancreatic adenocarcinoma. Phase II arm 3 will consist of approximately 28 patients with mutant BRAFV600 melanoma. Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. All patients will be followed up - at minimum patients must complete the safety follow-up assessments 30 days after the last dose of the study treatment.
NCT01562899 ↗ A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors Terminated Pfizer Phase 1/Phase 2 2012-08-27 This is a multi-center, open-label, phase Ib/II study. First, the aim of the phase Ib part is to estimate the MTD(s) and/or to identify the recommended phase II dose(s) (RP2D) for the combination of MEK162 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. The dose escalation part of the study will be guided by a Bayesian Logistic Regression Model (BLRM). At least 18 patients are expected to be enrolled in the dose escalation part. Following MTD/ RP2D declaration, patients will be enrolled in three phase II arms to assess efficacy of the combination as well as to better understand the safety, tolerability, PK, antibody concentrations and PD of the combination at MTD/RP2D. Phase II arm 1 will consist of approximately 25 patients with KRAS-mutant colorectal adenocarcinoma. Phase II arm 2 will consist of approximately 20 patients with metastatic pancreatic adenocarcinoma. Phase II arm 3 will consist of approximately 28 patients with mutant BRAFV600 melanoma. Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. All patients will be followed up - at minimum patients must complete the safety follow-up assessments 30 days after the last dose of the study treatment.
NCT01801358 ↗ A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma Terminated Array BioPharma Phase 1/Phase 2 2013-08-01 A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in a Phase II part of the study, which will enrol 55 patients each into two randomized groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Binimetinib

Condition Name

Condition Name for Binimetinib
Intervention Trials
Melanoma 8
Metastatic Melanoma 8
BRAF V600 Mutation 4
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Condition MeSH

Condition MeSH for Binimetinib
Intervention Trials
Melanoma 30
Colorectal Neoplasms 16
Carcinoma, Non-Small-Cell Lung 12
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Clinical Trial Locations for Binimetinib

Trials by Country

Trials by Country for Binimetinib
Location Trials
United States 296
Italy 28
Spain 28
Germany 20
China 18
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Trials by US State

Trials by US State for Binimetinib
Location Trials
California 27
Texas 22
New York 16
Florida 16
Massachusetts 15
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Clinical Trial Progress for Binimetinib

Clinical Trial Phase

Clinical Trial Phase for Binimetinib
Clinical Trial Phase Trials
Phase 3 3
Phase 2 33
Phase 1/Phase 2 17
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Clinical Trial Status

Clinical Trial Status for Binimetinib
Clinical Trial Phase Trials
Recruiting 47
Active, not recruiting 10
Not yet recruiting 8
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Clinical Trial Sponsors for Binimetinib

Sponsor Name

Sponsor Name for Binimetinib
Sponsor Trials
Array BioPharma 26
Pfizer 24
National Cancer Institute (NCI) 18
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Sponsor Type

Sponsor Type for Binimetinib
Sponsor Trials
Industry 89
Other 80
NIH 18
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