Status:
COMPLETED
A Pharmacokinetic Study of RO5185426 in Combination With a Drug Cocktail in Patients With Metastatic Melanoma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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, dex...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01001299
Start Date
November 30 2009
End Date
February 29 2012
Last Update
August 15 2017
Active Locations (5)
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1
UCLA - School of Medicine
Los Angeles, California, United States, 90095
2
Massachusetts General Hospital;Hematology/ Oncology
Boston, Massachusetts, United States, 02114
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
Vanderbilt-Ingram Cancer Ctr
Nashville, Tennessee, United States, 37232