A Dose-Escalation Study of RO5126766 in Patients With Advanced Solid Tumors.
This study will determine the maximum tolerated dose and the dose limiting toxic ities (Part 1 of study) and the activity (Part 2 of study) of RO5126766 in patie nts with metastatic or advanced solid tumors. In the first part of the study, gr oups of patients will by sequentially enrolled to receive ascending oral doses o f RO5126766 daily for 28 days. The starting dose of 0.1mg will be escalated in s ubsequent groups of patients after a successful assessment of the safety and tol erability of the previous dose. In Part 2 of the study, patients with selected t umor types will be randomized to receive either the optimal biological dose or t he maximum tolerated dose of RO5126766 daily. The anticipated time on study trea tment is until disease progression, and the target sample size is 100 individual s.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO5126766, a Dual Raf and MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors|
- Maximum tolerated dose (Part 1) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Tumor assessments (Part 2) [ Time Frame: Event driven ] [ Designated as safety issue: No ]
- AEs and laboratory parameters, ophthalmological examination, pharmacokinetic parameters, pharmacodynamic parameters (Parts 1 and 2). [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Administered orally daily for 28 days, at escalating doses (with a starting dose of 0.1mg) (Part 1). Optimal biological dose or maximum tolerated dose administered orally, daily (Part 2).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773526
|Villejuif, France, 94805|
|Barcelona, Spain, 08003|
|Sutton, United Kingdom, SM2 5PT|
|Study Director:||Clinical Trials||Hoffmann-La Roche|