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

Roche

Status and phase: Completed; Phase 1

Conditions: Malignant Melanoma

Treatments: Drug: RO5185426

Study type: Interventional

Funder types: Industry

Identifiers

NCT01164891

NP25158

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: RO5185426