CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 96 enrolled
Drug / intervention
Navitoclax +6 morebiological
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/NCT02079740
NCT02079740Phase 2Active

An Open Label, Two-Part, Phase Ib/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of the MEK Inhibitor Trametinib and the BCL2-Family Inhibitor Navitoclax (ABT-263) in Combination in Subjects With KRAS or NRAS Mutation-Positive Advanced Solid Tumors

National Cancer Institute (NCI)·interventional·Posted Mar 6, 2014·Updated May 28, 2026

In Brief

A Phase 2 clinical trial evaluating Biopsy Procedure, Biospecimen Collection, and 5 other interventions for Metastatic Malignant Solid Neoplasm and 2 related conditions. Active but no longer recruiting, targeting 96 participants across 2 sites.

Detailed Summary

This phase Ib/II trial studies the side effects and best dose of trametinib and navitoclax and how well they work in treating patients with solid tumors that have spread to other places in the body (advanced or metastatic). Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Navitoclax inhibits members of the BCL2 family of proteins that are believed to play key roles in promoting the survival of cancer cells. It may stop the growth of cancer cells by blocking Bcl-2, Bcl-XL, and Bcl-w, proteins needed for cancer cell survival. Giving trametinib and navitoclax may help stop the growth of tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2Active
20142015201620172018201920202021202220232024202520262027
First PostedMar 6, 2014
Enrollment StartMar 26, 2014
Primary CompletionDec 1, 2022
Study CompletionMar 9, 2027
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 12.3 years ago

Interventions

Biopsy Procedureprocedure

Undergo biopsy

Biospecimen Collectionprocedure

Undergo collection of blood samples

Computed Tomographyprocedure

Undergo conventional CT or PET/CT

Magnetic Resonance Imagingprocedure

Undergo MRI

Navitoclaxbiological

Given PO

Positron Emission Tomographyprocedure

Undergo PET/CT

Trametinibdrug

Given PO