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A Phase I Study of PLX4032 in Patients with Metastatic Melanoma

[Protocol 06-148]


Full Title :
A STUDY TO ASSESS SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PLX4032 IN PATIENTS WITH SOLID TUMORS
Purpose :

Most melanoma tumors grow because of a genetic mutation in a gene called BRAF. Many researchers believe that if BRAF can be blocked, the melanoma would stop growing. PLX4032 is a new investigational drug designed to block BRAF. This drug is being evaluated at Memorial Sloan-Kettering in patients with advanced melanoma.

In this phase I study, researchers will observe the side effects of PLX4032 and find the highest dose that can be given safely to patients. They also want to learn how long PLX4032 stays in the body, and see what effects PLX4032 has on patients' melanoma tumors.

Eligibility :

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

  • Patients must live within the tri-state area so that they can come to MSKCC weekly.
  • At least 2 weeks must have passed since completion of prior chemotherapy, radiation therapy, or hormonal therapy, and patients must have recovered from any side effects.
  • 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.
  • Patients cannot have brain metastases within the past 3 months.

For more information and to see if you are eligible for this study, please contact Ruth-Ann Roman 212-639-3446.

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