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A Phase II Trial of AZD6244 in Patients with V600E BRAF-Mutated Melanomas
[Protocol 09-003]
- Full Title :
- PHASE II TRIAL OF HYD-SULFATE AZD6244 (NSC 748727) IN PATIENTS WITH V600E BRAF MUTATED MELANOMAS (NCI #8252)
- Purpose :
The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called AZD6244 in patients with inoperable melanoma with mutations in the BRAF gene. AZD6244 is designed to block a protein called MEK, which melanomas depend on to grow -- especially melanomas with BRAF mutations. BRAF mutations are very common in patients with metastatic melanoma.
Researchers hope that blocking MEK will shut down this pathway in melanoma cells and stop them from growing. They want to find out how many patients respond to AZD6244 and what other genetic changes in the tumor are needed to respond to this drug.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have metastatic melanoma or stage III melanoma that is inoperable.
- Patients must have evidence of tumor progression.
- Patients' tumors must contain the V600E mutation in the BRAF gene.
- At least 4 weeks must have passed since completion of prior chemotherapy or radiation therapy and entry into the study.
- Patients may not have had prior MEK or BRAF inhibitors nor anti-CTLA-4 therapy.
- 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 must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Paul Chapman at 646-888-2378.
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