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NCI/CTEP# 9466: Phase I/II study of dabrafenib, trametinib, and navitoclax in BRAF mutant melanoma and other solid tumors

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NCI/CTEP# 9466: Phase I/II study of dabrafenib, trametinib, and navitoclax in BRAF mutant melanoma and other solid tumors

1.1 Phase I Objectives
1.1.1 Primary Objective
1.1.1.1 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.

1.1.2 Secondary Objectives
1.1.2.1 To describe pharmacodynamics effects of treatment with dabrafenib, trametinib, and navitocalx on both serial tumor biopsies and serial blood draws in a small subset of patients treated with BRAF-mutant melanoma.
1.1.2.2 To describe the pharmacokinetics of treatment with dabrafenib, trametinib, and navitoclax.


1.2 Phase II Objectives
1.2.1 Primary Objectives
1.2.1.1 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.
1.2.1.2 To compare the maximal tumor regression in patients with BRAF-mutant melanoma treated with dabrafenib, trametinib versus dabrafenib, trametinib, and navitoclax.


1.2.2 Secondary Objectives
1.2.2.1 To compare the PFS, OS, and ORR in patients with BRAF-mutant melanoma treated with dabrafenib, trametinib, versus dabrafenib, trametinib, and navitoclax.
1.2.2.2 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.
1.2.2.3 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.

Protocol Number: 091306
Phase: Phase I/II
Applicable Disease Sites: Melanoma, skin
Any Site
Drugs Involved: ABT-263
Trametinib
DABRAFENIB
Principal Investigator: Janice Mehnert
Research Nurse: Debbie Pomponio
For additional information about this trial, contact the Research Nurse listed above
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions: Rutgers Cancer Institute of New Jersey

For further information about clinical trials, please contact us at 732-235-8675.

 

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