Status: Closed
Activation Date: 2013APR15
Closing Date: 2014MAY23
Phase: III
Description: A Phase III Randomized Study of BBI608 and Best Supportive Care versus Placebo and Best Supportive Care in Patients with Pretreated Advanced Colorectal Carcinoma
Eligibility: Patients with pre-treated advanced colorectal carcinoma.
Objective: Primary Objective: -Overall Survival (OS) Secondary Objectives: -Progression-Free Survival (PFS) -Objective Response Rate (OR) -Disease Control Rate (DCR) -Safety profile -QoL, using the EORTC QLQ-C30 -HUI3, using the HUI3 index -Comparative economic evaluation -Exposure/response relationships of BBI608 using population PK -Association between putative biomarkers in tumour/blood & clinical benefit -Establish a comprehensive tumour bank linked to a clinical database
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, BBI608, or better to receive no further treatment for colon or rectal cancer.
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Inventory
Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GASTRO-INTESTINAL | CO23 | 282 | 211 | 272 | 276 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| GASTRO-INTESTINAL | CO23 | 282 | 3 | 176 |
| 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 | CO23 | 282 | 281 | 0 | 0 | 0 | 282 | 282 | 0 | 0 |