NCT01164891

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	RO5185426	Continuous oral dosing b.i.d. , on Day 15 a C isotope labeled dose will be administered

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-07-19
• Last updated: 2023-04-05
• Results posted: 2015-12-08

Locations

1 site across 1 country: Switzerland