A Phase II Clinical Trial of Trametinib plus GSK2141795 in Patients with Melanoma Containing a Normal BRAF Gene

Protocol
13-258
Full Title
Phase II Clinical Trial of the MEK Inhibitor Trametinib with the AKT Inhibitor GSK 2141795 in BRAF Wild-type Melanoma
Phase
II
Purpose

Melanomas that contain mutations in the BRAF gene may be treated with drugs that target the dysfunctional BRAF protein. For melanomas that do not have mutated BRAF, it may be necessary to block two other molecular pathways during treatment: the MAP kinase pathway and the PI3 kinase/AKT pathway. In this study, researchers are evaluating the safety and effectiveness of giving two drugs that target these pathways in patients with melanoma that does not contain mutated BRAF. The two drugs are trametinib and GSK2141795.

Trametinib is already approved for treating advanced melanoma with a BRAF mutation. It works by blocking MEK, a protein in the MAP kinase pathway. GSK2141795 is an investigational drug designed to inhibit cancer growth by blocking the activity of the AKT protein. Both drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable stage III or IV melanoma that does not contain mutated BRAF.
  • At least 2 weeks must have passed since the completion of prior therapies and entry into the study, and patients should have recovered from any serious side effects.
  • Patients may have had up to two prior regimens of chemotherapy, but may not have received prior drugs that inhibit AKT or MEK.
  • Patients with brain metastases may not participate unless the brain metastases have been treated and have been inactive for at least 4 weeks after stopping steroids.
  • Patients must be able to be walk and do routine activities for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Paul Chapman at 646-888-4162.

Disease(s)
Melanoma
Locations
Related Diseases