At a glance
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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
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
Timeline
Interventions
Undergo biopsy
Undergo collection of blood samples
Undergo conventional CT or PET/CT
Undergo MRI
Given PO
Undergo PET/CT
Given PO