BBI608 and Best Supportive Care vs Placebo and Best Supportive Care in Pretreated Advanced Colorectal Carcinoma
A Phase III Randomized Study of BBI608 and Best Supportive Care Versus Placebo and Best Supportive Care in Patients With Pretreated Advanced Colorectal Carcinoma
Sponsor: NCIC Clinical Trials Group
This PHASE3 trial investigates Colorectal Carcinoma and is currently completed. NCIC Clinical Trials Group leads this study, which shows 16 recorded versions since 2013 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)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.
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.
Status Flow
Change History
16 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE3
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Sep 2025 — Present [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Nov 2023 — Jul 2024 [monthly]
Completed PHASE3
▶ Show 11 earlier versions
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Sep 2023 — Nov 2023 [monthly]
Completed PHASE3
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Jan 2023 — Sep 2023 [monthly]
Completed PHASE3
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Dec 2022 — Jan 2023 [monthly]
Completed PHASE3
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May 2022 — Dec 2022 [monthly]
Completed PHASE3
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Jan 2021 — May 2022 [monthly]
Completed PHASE3
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Aug 2020 — Jan 2021 [monthly]
Completed PHASE3
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May 2020 — Aug 2020 [monthly]
Completed PHASE3
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Aug 2019 — May 2020 [monthly]
Completed PHASE3
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Apr 2019 — Aug 2019 [monthly]
Completed PHASE3
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Jun 2018 — Apr 2019 [monthly]
Completed PHASE3
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE3
First recorded
May 2013
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- NCIC Clinical Trials Group
- Sumitomo Pharma America, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Abbotsford, Canada , Bankstown, Australia , Barrie, Canada , Bedford Park, Australia , Bunbury, Australia , Calgary, Canada , Chiba, Japan , Douglas, Australia , East Melbourne, Australia , Edmonton, Canada and 44 more locations