A Dose-Escalation Study of RO5083945 in Patients With Metastatic and/or Locally Advanced Malignant Epidermal Growth Factor Receptor (EGFR)+ Solid Tumors.
This study will evaluate the pharmacokinetics, maximum tolerated dose and anti-tumor activity of RO5083945 in patients with metastatic and/or locally advanced malignant EGFR+ solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending doses of RO5083945 administered weekly, every 2 weeks or every 3 weeks. The starting dose of 50mg weekly will be escalated in subsequent groups of patients after a successful assessment of the safety, tolerability and pharmacokinetics of the previous dose. In Part 2 of the study, patients with EGFR+ and mutant KRAS colorectal cancer will be enrolled, and will receive RO5083945 at the recommended dose and regimen identified in Part 1. 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 Tumor Growth Control Rate of RO5083945, a Glycoengineered Antibody Against EGFR, in Patients With Metastatic and/or Locally Advanced Malignant EGFR+ Solid Tumors.|
- Pharmacokinetic parameters, and maximum tolerated dose (Part 1) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Tumor growth control rate (CR, PR, SD) (Part 2) [ Time Frame: Event driven ] [ Designated as safety issue: No ]
- AEs and laboratory parameters, pharmacodynamic parameters (Parts 1 and 2) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Anti-tumor activity (ORR, DR, PFS) (Part 2) [ Time Frame: Event driven ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Administered iv, either weekly, every 2 weeks or every 3 weeks, at escalating doses (with a starting dose of 50mg weekly (Part 1)). Recommended dose administered iv, either weekly, every 2 weeks or every 3 weeks (Part 2).
|Toulouse, France, 31059|
|Villejuif, France, 94805|
|Barcelona, Spain, 08035|
|Sevilla, Spain, 41013|
|Valencia, Spain, 46010|
|Study Director:||Clinical Trials||Hoffmann-La Roche|