A Dose-Escalation Study of RO5126766 in Patients With Advanced Solid Tumors.
This study will determine the maximum tolerated dose and the dose limiting toxicities (Part 1 of study) and the activity (Part 2 of study) of RO5126766 in patients with metastatic or advanced solid tumors. In the first part of the study, groups of patients will by sequentially enrolled to receive ascending oral doses of RO5126766 daily for 28 days. The starting dose of 0.1mg will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with selected tumor types will be randomized to receive either the optimal biological dose or the maximum tolerated dose of RO5126766 daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.
|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:||December 2011|
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).
|Villejuif, France, 94805|
|Barcelona, Spain, 08003|
|Sutton, United Kingdom, SM2 5PT|
|Study Director:||Clinical Trials||Hoffmann-La Roche|