NCT02231723

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, multi-center, multi-arm, dose-escalation study of BBI608 administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin.

Detailed description

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.

Conditions

• Metastatic Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	BBI608	Administered continuously twice daily with doses separated by 12 hours
DRUG	Nab-paclitaxel	Nab-paclitaxel 125 mg/m\^2 I.V. infusion on Days 1, 8, and 15 of every 28-day cycle
DRUG	Gemcitabine	Gemcitabine 1000 mg/m\^2 I.V. infusion on Days 1, 8, and 15 of every 28-day cycle
DRUG	Oxaliplatin	Oxaliplatin 85 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle
DRUG	Leucovorin	Arm C, D: Leucovorin 400 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle
DRUG	Irinotecan	Arm B: Irinotecan 165 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle, Arm C: Irinotecan 165 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle
DRUG	Fluorouracil	Arm B, D: Fluorouracil 2400 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle, Arm C: Fluorouracil 400 mg/m\^2 I.V. bolus followed by 2400 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle
DRUG	MM-398	MM-398 70 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle

Timeline

• Start date: 2014-08-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2014-09-04
• Last updated: 2023-11-18

Locations

12 sites across 1 country: United States