A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Pancreatic Cancer
A Phase Ib Clinical Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Metastatic Pancreatic Adenocarcinoma
Sponsor: Sumitomo Pharma America, Inc.
Listed as NCT02231723, this PHASE1 trial focuses on Metastatic Pancreatic Adenocarcinoma and remains completed. Sponsored by Sumitomo Pharma America, Inc., it has been updated 14 times since 2014, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)This is an open label, multi-center, multi-arm, dose-escalation study of BBI608 administered in combination with either Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin. A study cycle will consist of daily and continuous oral administration of BBI608 for four weeks (28 days) in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin. Combination treatment will continue in 28 day cycles until disease progression, unacceptable toxicity or another discontinuation criterion is met. BBI608 may be continued post-progression if the patient is obtaining potential clinical benefit, in the opinion of the investigator. If administration of Gemcitabine and/or nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin is discontinued due to chemotherapy backbone-related toxicities, the administration of BBI608 can be continued.
This is an open label, multi-center, multi-arm, dose-escalation study of BBI608 administered in combination with either Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin. A study cycle will consist of daily and continuous oral administration of BBI608 for four weeks (28 days) in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin. Combination treatment will continue in 28 day cycles until disease progression, unacceptable toxicity or another discontinuation criterion is met. BBI608 may be continued post-progression if the patient is obtaining potential clinical benefit, in the opinion of the investigator. If administration of Gemcitabine and/or nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin is discontinued due to chemotherapy backbone-related toxicities, the administration of BBI608 can be continued.
Status Flow
Change History
14 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE1
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Sep 2024 — Present [monthly]
Completed PHASE1
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
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Dec 2023 — Jul 2024 [monthly]
Completed PHASE1
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Nov 2023 — Dec 2023 [monthly]
Completed PHASE1
▶ Show 9 earlier versions
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May 2022 — Nov 2023 [monthly]
Completed PHASE1
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Jan 2021 — May 2022 [monthly]
Completed PHASE1
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Aug 2020 — Jan 2021 [monthly]
Completed PHASE1
Status: Active Not Recruiting → Completed
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Apr 2019 — Aug 2020 [monthly]
Active Not Recruiting PHASE1
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Oct 2018 — Apr 2019 [monthly]
Active Not Recruiting PHASE1
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Jun 2018 — Oct 2018 [monthly]
Active Not Recruiting PHASE1
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Oct 2017 — Jun 2018 [monthly]
Active Not Recruiting PHASE1
Status: Recruiting → Active Not Recruiting
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Feb 2017 — Oct 2017 [monthly]
Recruiting PHASE1
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Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE1
First recorded
Aug 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Sumitomo Pharma America, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .