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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.

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.

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.

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.

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.

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.

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.

BBI608

Regorafenib

Boston Biomedical

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.

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. A study cycle will consist of daily and continuous oral administration of BBI608 for four weeks (28 days) in combination with FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib, or irinotecan.

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

A Phase Ib/II Clinical Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer

Assessment of safety of napabucasin administered in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib, or irinotecan in participants with advanced gastrointestinal malignancies by reporting of adverse events and serious adverse events

Assessment of the objective response rate (ORR) of napabucasin administered in combination with FOLFIRI in patients with FOLFIRI/XELIRI-refractory metastatic colorectal cancer. The Objective Response Rate (ORR) is the proportion of participants with a complete response or partial response who have measurable disease at baseline imaging.

To determine the maximum concentration of napabucasin and the area under the plasma concentration vs. time curve of napabucasin when administered in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib.

To determine the response (increase or decrease) of biomarkers from biopsied tumors following the administration of napabucasin

To determine the anti-tumor activity (specifically the disease control rate) of napabucasin administered in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib, or irinotecan. Percentage of participants with a documented complete response, partial response and stable disease based on RECIST 1.1.

To determine the disease control rate of napabucasin administered in combination with FOLFIRI in patients with FOLFIRI/XELIRI-refractory metastatic colorectal cancer. Percentage of participants with a documented complete response, partial response and stable disease based on RECIST 1.1.

The effect of napabucasin given in combination with FOLFIRI on Progression Free Survival (PFS) of patients with FOLFIRI/XELIRI-refractory metastatic colorectal cancer. PFS of patients with FOLFIRI/XELIRI-refractory metastatic colorectal cancer.

The effect of napabucasin given in combination with FOLFIRI on Overall Survival (OS) of patients with FOLFIRI/XELIRI-refractory metastatic colorectal cancer.

Sumitomo Pharma America, Inc.

All participants who received at least 1 dose of napabucasin administered orally, twice daily, in combination with FOLFOX6 regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously starting on Day 1 of Cycle 1, after the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous intravenous (IV) infusion.

Napabucasin Plus FOLFOX6

All participants who received at least 1 dose of napabucasin administered orally, twice daily, in combination with FOLFOX6 plus bevacizumab regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously over 2 hours starting on Day1 of Cycle 1, following the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous IV infusion. Bevacizumab 5 mg/kg was administered intravenously following the oxaliplatin/leucovorin infusion.

Napabucasin Plus FOLFOX6 Plus Bevacizumab

All participants who received at least 1 dose of napabucasin administered orally, twice daily, in combination with CAPOX regimen. The CAPOX regimen was administered orally (capecitabine) and by IV (oxaliplatin). Starting on Day 1 of Cycle 1, capecitabine 850 mg/m2 was administered orally BID following the first daily dose of napabucasin for 14 consecutive days and repeated every 21 days. Oxaliplatin 130 mg/m2 was administered intravenously over 2 hours, following the first daily dose of napabucasin starting on Day 1 of Cycle 1 and repeated every 21 days thereafter. If capecitabine was tolerated at the 850 mg/m2 BID dose, the dosage could have been increased to 1000 mg/m2 BID as tolerated after the first cycle.

Napabucasin Plus CAPOX

All participants who received at least 1 dose of napabucasin administered orally, twice daily, in combination with FOLFIRI regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. This regimen was repeated every 14 days thereafter.

Napabucasin Plus FOLFIRI

All participants who received at least 1 dose of napabucasin administered orally, twice daily, in combination with FOLFIRI plus bevacizumab regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5 FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. Bevacizumab 5 mg/kg was administered intravenously following the irinotecan/leucovorin infusion. This regimen was repeated every 14 days thereafter.

Napabucasin Plus FOLFIRI Plus Bevacizumab

All participants who received at least 1 dose of napabucasin administered orally, twice daily, in combination with regorafenib 120 mg, administered orally once daily with a low-fat meal, starting on Day 1 of Cycle 1 for 21 consecutive days of every 28 days thereafter. If regorafenib was tolerated in the first cycle, the dosage could have been increased to 160 mg once daily as tolerated after the first cycle.

Napabucasin Plus Regorafenib

All participants who received at least 1 dose of napabucasin administered orally, twice daily, in combination with irinotecan 180 mg/m2, administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. This regimen was repeated every 14 days thereafter.

Napabucasin Plus Irinotecan

All participants who were enrolled to Arm A to receive napabucasin administered orally, twice daily, in combination with FOLFOX6 regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously starting on Day 1 of Cycle 1, after the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous intravenous (IV) infusion.

All participants who were enrolled to Arm B to receive napabucasin administered orally, twice daily, in combination with FOLFOX6 plus bevacizumab regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously over 2 hours starting on Day1 of Cycle 1, following the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous IV infusion. Bevacizumab 5 mg/kg was administered intravenously following the oxaliplatin/leucovorin infusion.

All participants who were enrolled to Arm C to receive napabucasin administered orally, twice daily, in combination with CAPOX regimen. The CAPOX regimen was administered orally (capecitabine) and by IV (oxaliplatin). Starting on Day 1 of Cycle 1, capecitabine 850 mg/m2 was administered orally BID following the first daily dose of napabucasin for 14 consecutive days and repeated every 21 days. Oxaliplatin 130 mg/m2 was administered intravenously over 2 hours, following the first daily dose of napabucasin starting on Day 1 of Cycle 1 and repeated every 21 days thereafter. If capecitabine was tolerated at the 850 mg/m2 BID dose, the dosage could have been increased to 1000 mg/m2 BID as tolerated after the first cycle.

All participants who were enrolled to Arm D to receive napabucasin administered orally, twice daily, in combination with FOLFIRI regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. This regimen was repeated every 14 days thereafter.

All participants who were enrolled to Arm E to receive napabucasin administered orally, twice daily, in combination with FOLFIRI plus bevacizumab regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5 FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. Bevacizumab 5 mg/kg was administered intravenously following the irinotecan/leucovorin infusion. This regimen was repeated every 14 days thereafter.

All participants who were enrolled to Arm F to receive napabucasin administered orally, twice daily, in combination with regorafenib 120 mg, administered orally once daily with a low-fat meal, starting on Day 1 of Cycle 1 for 21 consecutive days of every 28 days thereafter. If regorafenib was tolerated in the first cycle, the dosage could have been increased to 160 mg once daily as tolerated after the first cycle.

All participants who were enrolled to Arm G to receive napabucasin administered orally, twice daily, in combination with irinotecan 180 mg/m2, administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. This regimen was repeated every 14 days thereafter.

Total

Age, Continuous

Sex: Female, Male

American Indian or Alaska Native

Asian

Black

Native Hawaiian or Other Pacific Islander

White

Other

Race/Ethnicity, Customized

Tegan Nguyen

Napabucasin administered orally, twice daily, in combination with FOLFOX6 regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously starting on Day 1 of Cycle 1, after the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous intravenous (IV) infusion. Patients included in this group received at least one dose of study drug.

Napabucasin administered orally, twice daily, in combination with FOLFOX6 plus bevacizumab regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously over 2 hours starting on Day1 of Cycle 1, following the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous IV infusion. Bevacizumab 5 mg/kg was administered intravenously following the oxaliplatin/leucovorin infusion. Patients included in this group received at least one dose of study drug.

Napabucasin administered orally, twice daily, in combination with CAPOX regimen. The CAPOX regimen was administered orally (capecitabine) and by IV (oxaliplatin). Starting on Day 1 of Cycle 1, capecitabine 850 mg/m2 was administered orally BID following the first daily dose of napabucasin for 14 consecutive days and repeated every 21 days. Oxaliplatin 130 mg/m2 was administered intravenously over 2 hours, following the first daily dose of napabucasin starting on Day 1 of Cycle 1 and repeated every 21 days thereafter. If capecitabine was tolerated at the 850 mg/m2 BID dose, the dosage could have been increased to 1000 mg/m2 BID as tolerated after the first cycle. Patients included in this group received at least one dose of study drug.

Napabucasin administered orally, twice daily, in combination with FOLFIRI regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. This regimen was repeated every 14 days thereafter. Patients included in this group received at least one dose of study drug.

Napabucasin administered orally, twice daily, in combination with FOLFIRI plus bevacizumab regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5 FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. Bevacizumab 5 mg/kg was administered intravenously following the irinotecan/leucovorin infusion. This regimen was repeated every 14 days thereafter. Patients included in this group received at least one dose of study drug.

Napabucasin administered orally, twice daily, in combination with regorafenib 120 mg, administered orally once daily with a low-fat meal, starting on Day 1 of Cycle 1 for 21 consecutive days of every 28 days thereafter. If regorafenib was tolerated in the first cycle, the dosage could have been increased to 160 mg once daily as tolerated after the first cycle. Patients included in this group received at least one dose of study drug.

Napabucasin administered orally, twice daily, in combination with irinotecan 180 mg/m2, administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. This regimen was repeated every 14 days thereafter. Patients included in this group received at least one dose of study drug.

Number of Participants With Adverse Events and Serious Adverse Events

Napabucasin administered orally, twice daily, in combination with FOLFIRI regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. This regimen was repeated every 14 days thereafter . Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.

Analysis limited to a subset of group D in which patients had FOLFIRI/XELIRI refractory metastatic colorectal cancer. Patients in this subgroup also had a baseline scan and at least 1 disease assessment following the initiation of therapy.

The Objective Response Rate of Napabucasin Administered in Combination in FOLFIRI in Patients With FOLFIRI/XELIRI-refractory Metastatic Colorectal Cancer

Sponsor's decision to terminate further development of the napabucasin program. Data collection and analysis were therefore not conducted as planned.

Determination of the Maximum Observed Concentration (Cmax) and Area Under the Plasma Concentration vs. Time Curve (AUClast)

No on-treatment biopsies were performed therefore no pharmacodynamic testing on tumor tissue was conducted.

Pharmacodynamics

Napabucasin administered orally, twice daily, in combination with FOLFOX6 regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously starting on Day 1 of Cycle 1, after the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous intravenous (IV) infusion. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.

All participants who were enrolled to Arm B to receive napabucasin administered orally, twice daily, in combination with FOLFOX6 plus bevacizumab regimen administered every 14 days. The regimen consisted of oxaliplatin 85 mg/m2 together with leucovorin 400 mg/m2 administered intravenously over 2 hours starting on Day1 of Cycle 1, following the first daily dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following oxaliplatin/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2 over 46-48 hours) by continuous IV infusion. Bevacizumab 5 mg/kg was administered intravenously following the oxaliplatin/leucovorin infusion. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.

All participants who were enrolled to Arm C to receive napabucasin administered orally, twice daily, in combination with CAPOX regimen. The CAPOX regimen was administered orally (capecitabine) and by IV (oxaliplatin). Starting on Day 1 of Cycle 1, capecitabine 850 mg/m2 was administered orally BID following the first daily dose of napabucasin for 14 consecutive days and repeated every 21 days. Oxaliplatin 130 mg/m2 was administered intravenously over 2 hours, following the first daily dose of napabucasin starting on Day 1 of Cycle 1 and repeated every 21 days thereafter. If capecitabine was tolerated at the 850 mg/m2 BID dose, the dosage could have been increased to 1000 mg/m2 BID as tolerated after the first cycle. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.

All participants who were enrolled to Arm D to receive napabucasin administered orally, twice daily, in combination with FOLFIRI regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. This regimen was repeated every 14 days thereafter. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.

All participants who were enrolled to Arm E to receive napabucasin administered orally, twice daily, in combination with FOLFIRI plus bevacizumab regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5 FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. Bevacizumab 5 mg/kg was administered intravenously following the irinotecan/leucovorin infusion. This regimen was repeated every 14 days thereafter. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.

All participants who were enrolled to Arm F to receive napabucasin administered orally, twice daily, in combination with regorafenib 120 mg, administered orally once daily with a low-fat meal, starting on Day 1 of Cycle 1 for 21 consecutive days of every 28 days thereafter. If regorafenib was tolerated in the first cycle, the dosage could have been increased to 160 mg once daily as tolerated after the first cycle. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.

All participants who were enrolled to Arm G to receive napabucasin administered orally, twice daily, in combination with irinotecan 180 mg/m2, administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. This regimen was repeated every 14 days thereafter. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.

Patients who received at least 1 cycle of study treatment and had at least 1 disease assessment following the initiation of therapy. Patients missing imaging assessment following the initiation of treatment are not included in the assessment for DCR.

Disease Control Rate

Patients with FOLFIRI/XELIRI refractory metastatic colorectal cancer who received at least 1 cycle of study treatment and had at least 1 disease assessment following the initiation of therapy. Patients missing imaging assessment following the initiation of treatment are not included in the assessment for DCR.

Disease Control Rate of Patients With FOLFIRI/XELIRI-refractory Metastatic Colorectal Cancer

Napabucasin administered orally, twice daily, in combination with FOLFIRI regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. This regimen was repeated every 14 days thereafter. Patients in this group had a baseline scan and at least one on study scan or died from any cause.

Analysis limited to a subset of group D in which patients had FOLFIRI/XELIRI refractory metastatic colorectal cancer. Patients in this subgroup also had a baseline scan and at least 1 on study scan or died from any cause.

Progression Free Survival of Patients With FOLFIRI/XELIRI-refractory Metastatic Colorectal Cancer

Napabucasin administered orally, twice daily, in combination with FOLFIRI regimen. Irinotecan 180 mg/m2 together with leucovorin 400 mg/m2 was administered intravenously starting on Day 1 of Cycle 1, following the first dose of napabucasin. A 5-FU 400 mg/m2 bolus was administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/m2/day (total 2400 mg/m2) by continuous infusion. This regimen was repeated every 14 days thereafter . The patients in this subgroup were assessed to have FOLFIRI/XELIRI refractory metastatic colorectal cancer prior to enrollment.

Analysis limited to a subset of group D in which patients had FOLFIRI/XELIRI refractory metastatic colorectal cancer.

Spots Global Cancer Trial Database for A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer

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