A Phase II Study of LGX818 Given in a Pulsatile Schedule to Patients with Stage III or IV Melanoma with a BRAF Mutation

Protocol
13-053
Full Title
A Phase 2 Trial of the BRAF Inhibitor, LGX818, Utilizing a Pulsatile Schedule in Patients with Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation
Phase
II
Purpose

BRAF is a gene that is often mutated in melanoma tumors. There are drugs that target the BRAF protein which initially work in many patients, but typically the cancer starts growing again in about six months. The purpose of this study is to evaluate the safety and effectiveness of an investigational BRAF inhibitor, called LGX818, given in a “pulsatile” schedule (in which the patient takes short breaks from the drug) to potentially reduce the development of drug resistance.

Prior studies have shown that most patients who received LGX818 experienced tumor shrinkage. In this study, it will be given in patients with inoperable stage III melanoma or metastatic (stage IV) melanoma that contains a BRAF mutation. LGX818 is 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 melanoma or metastatic (stage IV) melanoma that is positive for the V600 BRAF mutation.
  • Patients may have had prior treatment, but not therapy with a BRAF or MEK inhibitor.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • 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.

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Disease(s)
Melanoma
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