Melanoma Clinical Trial
A Pharmacokinetic Study of RO5185426 in Combination With a Drug Cocktail in Patients With Metastatic Melanoma
Summary
This open-label single-arm study will evaluate the effect of RO5185426 [RG7204; PLEXXIKON: PLX4032] on the pharmacokinetics of five CYP450 substrates (caffeine, warfarin + vitamin K, omeprazole, dextromethorphan, midazolam) administered as a drug cocktail to patients with metastatic melanoma. The study will also evaluate efficacy and safety of RO5185426. On day 1, patients will receive the drug cocktail. On days 6 to 19, patients will receive RO5185426 twice daily. On day 20, patients will receive RO5185426 and the drug cocktail and on days 21 to 25, patients will receive RO5185426. Assessments will be made at regular intervals during the dosing periods and at follow-up. Patients may continue on study treatment (RO5185426) until the development of progressive disease or unacceptable toxicity. Target sample size <50.
Eligibility Criteria
Inclusion Criteria:
Adult patient >/= 18 years of age
Malignant melanoma (Stage IV, AJCC)
Patients who are treatment-naive or have received prior systemic treatments for metastatic melanoma. Time elapsed between previous treatment for metastatic disease and first administration of study drug must be at least 28 days
Positive tested for BRAF mutation
Patients must not be poor metabolizers of CYP450 enzymes 2C9, 2C19, or 2D6 as determined by genotyping
Measurable disease by RECIST criteria
Negative pregnancy test; for fertile men and women, effective contraception during treatment and for 6 months after completion
Exclusion Criteria:
Active CNS lesions on CT/MRI within 28 days prior to enrollment
History of known spinal cord compression, or carcinomatous meningitis
Severe cardiovascular disease within 6 months prior to study
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 5 Locations for this study
Los Angeles California, 90095, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75246, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.