BBI608 and Best Supportive Care vs Placebo and Best Supportive Care in Patients With Pretreated Advanced Colorectal Carcinoma
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|ClinicalTrials.gov Identifier: NCT01830621|
Recruitment Status : Completed
First Posted : April 12, 2013
Last Update Posted : February 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Carcinoma||Drug: BBI608 Drug: Placebo Other: Best Supportive Care||Phase 3|
This research is being done because currently there are no approved remaining effective treatments for colon or rectal cancer.
The purpose of this study is to compare the effects on colon cancer of a new drug, BBI608, and best supportive care (BSC) compared to BSC alone.
BBI608 has been shown to shrink tumours in animals and has been studied in a few people and seems promising, but it is not clear if it can offer better results than the usual care which is best supportive care alone.
The standard or usual treatment for this disease is treatment with drugs and other treatments that may help to make a patient feel better or may improve their quality of life. This treatment is known as "best supportive care" (BSC). Although patients with best supportive care can feel better for some months, the cancer usually continues to grow.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||282 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase III Randomized Study of BBI608 and Best Supportive Care Versus Placebo and Best Supportive Care in Patients With Pretreated Advanced Colorectal Carcinoma|
|Study Start Date :||April 2013|
|Primary Completion Date :||August 2015|
|Study Completion Date :||May 2016|
Active Comparator: BBI608
BBI608 480 mg two times daily (960 mg total daily dose)+ Best Supportive Care
|Drug: BBI608 Other: Best Supportive Care|
Placebo Comparator: Placebo
Placebo two times daily + Best Supportive Care
|Drug: Placebo Other: Best Supportive Care|
- Overall Survival [ Time Frame: 38 month ]The primary objective of this study is to assess the effect of orally administered BBI608 plus best supportive care (BSC), in comparison to placebo plus best supportive care on the Overall Survival of patients with advanced histopathologically confirmed colorectal carcinoma who have exhausted all standard treatment options
- Progression Free Survival [ Time Frame: 38 months ]Defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.
- Disease Control Rate [ Time Frame: 38 months ]Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
- Number of Patients with Adverse Events [ Time Frame: 38 months ]All patients who have received at least one dose of BBI608/Placebo will be included in the safety analysis. The incidence of adverse events will be summarized by type of adverse event and severity.
- Quality of Life [ Time Frame: 38 months ]The primary endpoints in QoL analysis are the mean EORTC QLQ-C30 QoL change scores from baseline at time 2 (8 weeks) and time 4 (16 weeks) for the physical function and global health status/quality of life subscale scores.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830621
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|Study Chair:||Derek Jonker||Ottawa Health Research Institute - General Division|