A Phase III Clinical Study of Napabucasin (GB201) Plus FOLFIRI in Adult Patients With Metastatic Colorectal Cancer

Sponsor
1Globe Health Institute LLC
Study ID
NCT03522649
Phase
PHASE3
Status
Unknown

Conditions

  • Previously Treated Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Napabucasin — DRUG
    Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 8\~12 hours.
  • Fluorouracil — DRUG
    Fluorouracil 400 mg/m\^2 bolus will be administered intravenously immediately following irinotecan/leucovorin infusion, followed by Fluorouracil 1200 mg/m\^2/day (total 2400 mg/m\^2) continuous infusion.
  • Leucovorin — DRUG
    Irinotecan 180 mg/m\^2 followed by or concurrent with leucovorin 400 mg/m\^2 will be administered intravenously, over approximately 90 minutes and 2 hours, respectively.
  • Irinotecan — DRUG
    Irinotecan 180 mg/m\^2 followed by or concurrent with leucovorin 400 mg/m\^2 will be administered intravenously, over approximately 90 minutes and 2 hours, respectively.

Study Details

This is a randomized, open-label, multi-center, phase III study of Napabucasin plus bi-weekly FOLFIRI (Arm 1) vs. Napabucasin (Arm 2) for adult patients with metastatic CRC who have failed standard chemotherapy regimens. For patients who have failed bevacizumab with irinotecan-based chemotherapies (treatment failure is defined as radiologic progression of disease during or within 3 months following the last dose), bevacizumab maybe administered in combination with FOLFIRI to patients randomized to Arm 1.

Key Dates

Start date
Apr 12, 2018
Status verified
May 2019
Primary completion
Nov 30, 2021
Completion
Nov 30, 2021

Study Design

Enrollment
668 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Napabucasin plus FOLFIRI
    Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 8\~12 hours. For patients who have failed bevacizumab with irinotecan-based chemotherapies, bevacizumab may be administered with FOLFIRI. FOLFIRI infusion will start at least 2 hours following the first daily dose of napabucasin and will be administered every 2 weeks, starting on C1D1. If bevacizumab is added to FOLFIRI, bevacizumab infusion should start at least 2 hours following the first daily dose of napabucasin and will be administered every 2 weeks. Irinotecan/leucovorin infusion will follow bevacizumab infusion. 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 continuous infusion. For patients who could not tolerate FOLFIRI at the full dose previously, FOLFIRI should be started at the same dose level the patient tolerated FOLFIRI previously.
  • Other: Napabucasin
    Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 8\~12 hours.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: 43 months ]

Central Contacts