Status:
COMPLETED
A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic Melanoma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This open-label, non-randomized study will assess the mass balance, metabolism, routes and rates of elimination as well as efficacy and safety of RO5185426 (RG7204; PLEXXIKON; PLX4032) in previously t...
Eligibility Criteria
Inclusion
- Adult patients, \>/= 18 years of age
- Histologically confirmed metastatic melanoma, surgically incurable and unresectable Stage IIIc or IV (AJCC)
- Prior treatment for metastatic melanoma allowed; \>/= 28 days must be elapsed since previous systemic treatment prior to first administration of study drug
- Positive BRAF V600E mutation result (by Roche CoDx test)
- ECOG performance status 0-1
- Adequate hematologic, renal and liver function
- Body Mass Index (BMI) 18 to 32 kg/m2 inclusive
Exclusion
- Active CNS lesions
- History of or known spinal cord compression, or carcinomatous meningitis
- Anticipated or ongoing administration of any anticancer therapies other than those administered in this study
- Refractory nausea or vomiting, or other medical conditions that are capable of altering the absorption, metabolism or elimination of the study drug
- Known clinically significant active infection
- Known HIV positivity or AIDS-related illness, active HBV, or active HCV
- Previous malignancy within the past 5 years, except for basal or squamous cell carcinoma of the skin, melanoma in situ, and carcinoma in situ of the cervix
- Clinically significant cardiovascular disease or incident within the 6 months prior to study drug administration
- Patients who have had at least one dose of study drug (RO5185426 or comparator) in a clinical trial that includes RO5185426
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01164891
Start Date
July 1 2010
End Date
December 1 2012
Last Update
April 5 2023
Active Locations (1)
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1
Zurich, Switzerland, 8091