Full TitlePhase I Trial of Phenformin with Combination BRAF inhibitor/MEK inhibitor in Patients with BRAFV600E/K- Mutated Melanoma
Dabrafenib and trametinib are both used to treat melanoma. Dabrafenib works by blocking the activity of the abnormal BRAF protein. Trametinib works by blocking a protein involved in cancer growth called MEK. However, resistance to these drugs often emerges and the cancer continues to grow.
Phenformin is a diabetes drug that also activates a protein called AMPK. Increased AMPK activity inhibits the same pathway through which BRAF and MEK work. Adding phenformin to treatment with dabrafenib and trametinib may therefore be more effective against BRAF-mutated melanoma than dabrafenib and trametinib alone.
In this study, researchers want to find the highest dose of phenformin that can be given safely with dabrafenib and trametinib in patients with melanoma containing aV600 BRAF mutation. All three drugs are taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have inoperable or metastatic melanoma that contains the V600 BRAF mutation.
- Patients may not be receiving treatment for diabetes.
- Patients must recover from the serious side effects of prior therapies before entering the study.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for patients age 18 and older.