BEP Study Phase I (Bevacizumab, Everolimus, Panitumumab)
Targeting molecular pathways of tumor growth has become a major focus of anti-cancer treatments. This study aims to investigate the toxicity, pharmacokinetics, and preliminary efficacy of the triplet combination of bevacizumab, RAD001, and panitumumab in patients with refractory solid tumors.
This open-labeled, non-randomized phase I trial of bevacizumab, everolimus and panitumumab is designed to assess the safety, tolerability and efficacy of this combination in adult patients with advanced solid tumors.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Phase I Study of Bevacizumab, Everolimus, and Panitumumab for Patients With Advanced Solid Tumors|
- To determine the MTD/recommended phase II regimen and evaluate safety of panitumumab added to RAD001 plus bevacizumab in adult patients with advanced solid tumors. [ Time Frame: Every cycle (28-days) ] [ Designated as safety issue: Yes ]
- To preliminarily describe any clinical activity (PR, CR or duration of SD) associated with this regimen [ Time Frame: Every cycle (28-days) ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
This is a Phase I safety study. There is only one arm.
Drug: bevacizumab, everolimus, panitumumab
Cohort # subjects Bevacizumab Everolimus Panitumumab
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|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Herbert I Hurwitz, MD||Duke University|