NCT01107418

A Pharmacokinetic/Pharmacodynamic Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma

A Phase I, Randomized, Open-label, Multi-center, Multiple Dose Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO5185426 Administered as 240 mg Tablets to Previously Treated BRAF V600E Positive Metastatic Melanoma Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label study will assess the pharmacokinetics, efficacy and safety of RO5185426 administered as 240mg tablets in previously treated patients with metastatic melanoma. Patients will be randomized to receive one of four dose-levels of RO5185426 \[RG7204; PLEXXIKON; PLX4032\] orally twice daily on days 1 to 15 (morning dose). Starting on day 22, treatment with RO5185426 may be resumed at a dose of 960 mg twice daily and continued until disease progression. Target sample size is \<100 patients.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	RO5185426	dosage b) orally twice daily, days 1-15 (morning dose)
DRUG	RO5185426	dosage c) orally twice daily, days 1-15 (morning dose)
DRUG	RO5185426	dosage d) orally twice daily, days 1-15 (morning dose)
DRUG	RO5185426	960 mg orally twice daily, from day 22 onward
DRUG	RO5185426	dosage a) orally twice daily, days 1-15 (morning dose)

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2010-04-21
• Last updated: 2015-08-26
• Results posted: 2015-08-26

Locations

13 sites across 2 countries: United States, Australia