A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer

Conditions

• Advanced Gastrointestinal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BBI608 — DRUG
• Fluorouracil — DRUG
• Oxaliplatin — DRUG
• Leucovorin — DRUG
• Irinotecan — DRUG
• Bevacizumab — DRUG
• Capecitabine — DRUG
• Regorafenib — DRUG

Study Details

This is an open label, multi-center, Phase 1/2 dose escalation study of BBI608 administered in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib, or irinotecan.

Key Dates

Start date

Jan 31, 2014

Status verified

Nov 2023

Primary completion

Mar 31, 2019

Completion

Nov 30, 2019

Study Design

Enrollment

495 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: ARM A- BBI608 in combination with FOLFOX6
  BBI608 is administered orally twice daily, continuously. Oxaliplatin 85 mg/m\^2 together with leucovorin 400 mg/m\^2 will be administered intravenously. 5-FU 400 mg/m\^2 bolus will be administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m\^2/day (total 2400 mg/m\^2 over 46-48 hours) continuous intravenous infusion. This regimen will be repeated every 14 days thereafter.
• Experimental: ARM B- BBI608 in combination with FOLFOX6 and Bevacizumab
  BBI608 is administered orally twice daily, continuously. Oxaliplatin 85 mg/m\^2 together with leucovorin 400 mg/m\^2 will be administered intravenously. 5-FU 400 mg/m\^2 bolus will be administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m\^2/day (total 2400 mg/m\^2 over 46-48 hours) continuous intravenous infusion. Bevacizumab 5 mg/kg will be administered intravenously following oxaliplatin/leucovorin infusion. This regimen will be repeated every 14 days thereafter.
• Experimental: ARM C- BBI608 in combination with CAPOX
  BBI608 is administered orally twice daily, continuously. CAPOX regimen will be administered orally (capecitabine) and IV (oxaliplatin). Capecitabine 850 mg/m\^2 will be administered orally twice-daily for 14 consecutive days and be repeated every 21 days. Oxaliplatin will be administered IV and be repeated every 21 days thereafter. If capecitabine is tolerated at the 850 mg/m\^2 twice daily dose, dosage may be increased to 1000 mg/m\^2 twice daily as tolerated after the first cycle.
• Experimental: ARM D- BBI608 in combination with FOLFIRI
  BBI608 is administered orally twice daily, continuously. Irinotecan 180 mg/m\^2 together with leucovorin 400 mg/m\^2 will be administered intravenously. 5-FU 400 mg/m\^2 bolus will be administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m\^2/day (total 2400 mg/m\^2) continuous infusion. This regimen will be repeated every 14 days thereafter.
• Experimental: ARM E- BBI608 in combination with FOLFIRI and Bevacizumab
  BBI608 is administered orally twice daily, continuously. Irinotecan 180 mg/m\^2 together with leucovorin 400 mg/m\^2 will be administered intravenously 5-FU 400 mg/m\^2 bolus will be administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m\^2/day (total 2400 mg/m\^2) continuous infusion. Bevacizumab 5 mg/kg will be administered intravenously following oxaliplatin/leucovorin infusion. This regimen will be repeated every 14 days thereafter.
• Experimental: ARM F- BBI608 in combination with Regorafenib
  BBI608 is administered orally twice daily, continuously. Regorafenib 120 mg will be administered orally once daily, with a low-fat meal and be continued for 21 consecutive days of every 28 days thereafter. If regorafenib is tolerated in the first cycle, dosage may be increased to 160 mg once daily as tolerated after the first cycle.
• Experimental: Arm G- BBI608 in combination with Irinotecan
  BBI608 is administered orally twice daily, continuously. Irinotecan 180 mg/m\^2 will be administered intravenously. This regimen will be repeated every 14 days thereafter.

Primary Outcome Measure

Number of Participants With Adverse Events and Serious Adverse Events [ Time Frame: The time from the date of first treatment, while the patient is taking napabucasin, and for 30 days after stopping therapy, an average of 4 months. ]

Locations (14)

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