CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 102 enrolled
Drug / intervention
Binimetinib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03981614
NCT03981614Phase 2Completed

Combination of MEK Inhibitor Binimetinib and CDK4/6 Inhibitor Palbociclib in KRAS and NRAS Mutant Metastatic Colorectal Cancers

Academic and Community Cancer Research United·interventional·Posted Jun 11, 2019·Updated Aug 22, 2024

In Brief

A Phase 2 clinical trial evaluating Binimetinib, Palbociclib, and 1 other intervention for Metastatic Colorectal Carcinoma and 5 related conditions. Completed, enrolled 102 participants across 7 sites.

Detailed Summary

This phase II trial studies how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Binimetinib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving binimetinib and palbociclib may work better compared to TAS-102 alone in treating patients with colorectal cancer.

Study Details

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 11, 2019
Enrollment StartOct 29, 2019
Primary CompletionAug 23, 2021
Study CompletionJul 2, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.1 years ago

Interventions

Binimetinibdrug

Given PO

Palbociclibdrug

Given PO

Trifluridine and Tipiracil Hydrochloridedrug

Given PO