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

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    1Globe Health Institute LLC
Updated on 23 January 2021


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.

Condition Previously Treated Metastatic Colorectal Cancer
Treatment fluorouracil, Irinotecan, Leucovorin, Napabucasin
Clinical Study IdentifierNCT03522649
Sponsor1Globe Health Institute LLC
Last Modified on23 January 2021


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Inclusion Criteria

Histologically confirmed adenocarcinoma of the colon or rectum that is metastatic (Stage IV)
Progression during or within 3 months following the last administration of standard chemotherapy based regimens containing a fluoropyrimidine, irinotecan and oxaliplatin. Patients treated with oxaliplatin or irinotecan in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy
Patients who are candidates for and have access to anti-VEGF therapy (i.e. bevacizumab and regorafenib) and anti-EGFR therapy (i.e. cetuximab and panitumumab) and/or TAS-102 must have received appropriate therapy
Patients with measurable or non measurable disease
Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1
Adequate bone marrow, liver and renal function

Exclusion Criteria

Anti-cancer chemotherapy, biologic therapy or any other systemic therapy if administered prior to the first planned dose of study medication within period of time equivalent to the usual cycle length of the regimen. An exception is made for oral fluoropyrimidines (e.g. capecitabine, S-1), where a minimum of 10 days since last dose must be observed prior to the first planned dose of protocol treatment
Major surgery within 4 weeks prior to randomization
Any known brain or leptomeningeal metastases are excluded, even if treated
Known hypersensitivity to 5-FU/LV or patients who as a result of toxicity had to reduce or stop 5-FU infusion at the dose of 900 mg/m^2/day (total 1800 mg/m^2/day)
Known hypersensitivity to irinotecan or patients who as a result of toxicity had to reduce or stop irinotecan infusion at the dose of 120 mg/m^2
Known history of human immunodeficiency virus (HIV) infection. Known chronic hepatitis B or C active infection
Known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
Known dihydropyrimidine dehydrogenase (DPD) deficiency
Patients with QTc interval > 470 millisecond
Uncontrolled intercurrent illness
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