A Phase III Clinical Study of Napabucasin (GB201) Plus FOLFIRI in Adult Patients With Metastatic Colorectal Cancer
A Phase III, Randomized, Open-Label Clinical Study of Napabucasin (GB201) in Combination With FOLFIRI Versus Napabucasin in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC)
1 other identifier
interventional
668
1 country
37
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2018
Typical duration for phase_3
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 12, 2018
CompletedFirst Submitted
Initial submission to the registry
May 1, 2018
CompletedFirst Posted
Study publicly available on registry
May 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedJune 18, 2019
May 1, 2019
3.6 years
May 1, 2018
June 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
To assess the effect of Napabucasin plus biweekly FOLFIRI versus Napabucasin on the Overall Survival of patients with previously treated metastatic colorectal cancer.
43 months
Secondary Outcomes (9)
Progression free survival (PFS)
43 months
Objective response rate (ORR)
43 months
Disease control rate (DCR)
43 months
Number of Patients with Adverse Events
43 months
Quality of Life (QoL)
43 months
- +4 more secondary outcomes
Study Arms (2)
Napabucasin plus FOLFIRI
EXPERIMENTALNapabucasin 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.
Napabucasin
OTHERNapabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 8\~12 hours.
Interventions
Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 8\~12 hours.
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.
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Beijng Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
Nanfang Hospital
Guangzhou, Guangdong, 510515, China
The Sixth Affiliated Hospital of Sun Yat - sen University
Guangzhou, Guangdong, 510655, China
Forth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150040, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430023, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
The 81 Hospital of the Chinese People's Liberation Army
Nanjing, Jiangsu, 210002, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
Jiangsu Provence Hospital
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jilin Cancer Hospital
Changchun, Jilin, 130021, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021, China
Liaoning Provincial Cancer Hospital
Shenyang, Liaoning, 110042, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
The Affiliated Hospital Qingdao University
Qingdao, Shandong, 266103, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120, China
Ren Ji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
The First Affiliated Hospital of Xi' AnJiaotong University
Xi’an, Shanxi, 710061, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, 310006, China
The Second Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, 310009, China
Sir Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310016, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2018
First Posted
May 11, 2018
Study Start
April 12, 2018
Primary Completion
November 1, 2021
Study Completion
November 1, 2021
Last Updated
June 18, 2019
Record last verified: 2019-05