A Phase I, Open-label, Excretion Balance, Pharmacokinetic and Metabolism Study After Single Oral Dose of 14C-labeled RO5185426 in Previously Treated and Untreated Patients With Metastatic Melanoma
Inclusion Criteria:
- 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 Criteria:
- 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