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UM1 9466 Dabrafenib, Trametinib, and Navitoclax in Melanoma & Solid Tumors - Clinical Trial

What is the Purpose of this Study?

We are doing this study to test the safety and side effects of the study drug navitoclax in combination with dabrafenib and trametinib at different doses.

What is the Condition Being Studied?

Melanoma with a mutation, a change in a cancer gene called BRAF that helps cancer grow

Who Can Participate in the Study?

Adults with BRAF-mutant (V600E/K) melanoma that is metastatic (has spread) or is unresectable (cannot be removed using surgery) and for which standard curative measures do not exist or are no longer effective.

Age Group
Adults

What is Involved?

This study is divided into two parts.

In the first part of this study, you will receive navitoclax for one week by itself before dabrafenib and trametinib are started.

The second part of this study has two study groups.
If you are enrolled in the second part of this study, a computer will randomly (like flipping a coin) put you in a study group. This is done because no one knows if one study group is better, the same, or worse than the other group. Once you are put in one group, you cannot switch to the other group.

Group 1 will get the usual drug combination used for this type of cancer dabrafenib plus trametinib plus a study drug called navitoclax.

Group 2 will get only the usual drug combination used for this type of cancer consisting of dabrafenib plus trametinib.

Study Details

Full Title
Phase I/II study of dabrafenib, trametinib, and navitoclax in BRAF mutant melanoma (Phase I and II) and other solid tumors (Phase I only)
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00094262
NCT:NCT01989585
Phase
Phase I/II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698