BBI608 and Best Supportive Care vs Placebo and Best Supportive Care in Pretreated Advanced Colorectal Carcinoma
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|ClinicalTrials.gov Identifier: NCT01830621|
Recruitment Status : Completed
First Posted : April 12, 2013
Results First Posted : March 11, 2019
Last Update Posted : April 14, 2020
|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|
|Actual Study Start Date :||April 15, 2013|
|Actual Primary Completion Date :||December 21, 2015|
|Actual Study Completion Date :||May 16, 2016|
Active Comparator: BBI608
BBI608 480 mg two times daily (960 mg total daily dose)+ Best Supportive Care
Other: Best Supportive Care
Placebo Comparator: Placebo
Placebo two times daily + Best Supportive Care
Other: Best Supportive Care
- Overall Survival [ Time Frame: 38 month ]Time from the day of randomization to death. For alive patients, overall survival was censored at the last day the patient was known alive (LKA).
- 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 ]Proportion of all randomized patients with a documented complete response (CR) defined as disappearance of all target lesions, partial response (PR) defined as >=30% decrease in the sum of the longest diameter of target lesions, and stable disease (SD) defined as <30% decrease but also <20% increase in the sum of the longest diameter of target lesions without new lesions per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1 for target lesion.
- Number of Patients With Adverse Events [ Time Frame: 38 months ]Number of patients with at least one adverse event as assessed by NCI CTCAE Version 3.0 criteria.
- Change of Global Quality of Life at 8 Weeks From Baseline [ Time Frame: 8 weeks ]Change scores from baseline at time 2 (8 weeks) from baseline for the global health status/quality of life scale scores (between 0 and 100 with higher value indicating better quality of life) as derived from responses of patients to the EORTC (European Organisation for Research and Treatment of Cancer) quality of life questionnaire (QLQ-C30).
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
|Study Chair:||Derek Jonker||Ottawa Health Research Institute - General Division|