Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic Melanoma
