Status: Closed
Activation Date: 2008FEB05
Closing Date: 2011FEB10
Phase: III
Description: A Phase III Randomized Study of Brivanib Alaninate (BMS-582664) in Combination with Cetuximab (Erbitux) Versus Placebo in Combination with Cetuximab (Erbitux) in Patients With K-Ras Wild Type Tumours Previously Treated With Combination Chemotherapy for Metastatic Colorectal Carcinoma
Eligibility: Patients with pre-treated metastatic K-Ras wild type colorectal carcinoma.
Objective: Primary To compare overall survival Secondary To compare progression-free survival To compare the objective response rate To compare the duration of response To compare the quality of life in patients To compare health utilities To conduct a comparative economic evaluation To evaluate the safety profile of cetuximab administered weekly and brivanib/placebo taken daily To examine molecular markers Banking of tissue
Participation: Open to member centres
Lay Description: The purpose of this study is to find out whether it is better to receive a new drug, brivanib, in combination with cetuximab, or better to receive only cetuximab for colon or rectal cancer.
Primary Publication Show
Other Publications Show
Inventory
Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GASTRO-INTESTINAL | CO20 | 750 | 489 | 499 | 665 |
(Core size is 0.6 mm)
Hide
Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| GASTRO-INTESTINAL | CO20 | 750 | 3 | 74 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| GASTRO-INTESTINAL | CO20 | 750 | 645 | 0 | 603 | 0 | 746 | 1 | 0 | 0 |