Cancer Type: Cutaneous
Study Type: Treatment
Phase: Phase I/II
Principal Investigator: Eroglu, Zeynep
Phase I/II Study of Dabrafenib, Trametinib, and Navitoclax in BRAF Mutant Melanoma (Phase I and II) and Other Solid Tumors (Phase I only)
Phase I Objective: Primary Object To determine the maximum tolerate dose (MTD), toxicity, and safety profile of navitoclax when given in combination with dabrafenib and trametinib in patients with BRAF-mutant solid tumors. Secondary Objectives: To describe pharmacodynamics effects of treatment with dabrafenib, trametinib, and navitoclax on both serial tumor biopsies and serial blood draws in a small subset of patients treated with BRAF-mutant melanoma. - To describe the pharmacokinetics of treatment with dabrafenib, trametinib, and navitoclax. Phase II Objectives: Primary Objectives - To estimate the complete response (CR) rate in patients with BRAF-mutant melanoma treated with dabrafenib, trametinib, and navitoclax as compared to the historical control (DT). - To compare the maximal tumor regression in patients with BRAF-mutant melanoma treated with dabrafenib, trametinib versus dabrafenib, trametinib, and navitoclax Secondary Objectives: - To compare the PFS, OS, and ORR in patients with BRAF-mutant melanoma treated with dabrafenib, trametinib, versus dabrafenib, trametinib, and navitoclax. - To compare the degree of apoptosis induced in on-treatment biopsies of patients with BRAF-mutant melanoma treated with dabrafenib, trametinib versus dabrafenib, trametinib, and navitoclax. - To explore other pharmacodynamic effects in on-treatment biopsies of patients with BRAF-mutant melanoma treated with either dabrafenib, trametinib versus dabrafenib, trametinib, and navitoclax including cell proliferation (Ki-67), proteomics (RPPA), and BCL-2 family gene expression analysis.
ABT-263 (Navitoclax); GSK1120212 (Trametinib); GSK2118436 (dabrafenib); Navitoclax (); Trametinib (); dabrafenib ()
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