A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic Melanoma

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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 treated or untreated patients with metastatic melanoma. Patients will receive continuous twice daily oral treatment with RO5185426. On Day 15, a 14C-labeled dose will be administered. Anticipated time on study treatment is until disease progression occurs.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

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