A Phase III Clinical Study of Napabucasin (GB201) Plus FOLFIRI in Adult Patients With Metastatic Colorectal Cancer
NCT ID: NCT03522649
Last Updated: 2019-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
668 participants
INTERVENTIONAL
2018-04-12
2021-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Napabucasin
Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 8\~12 hours.
Fluorouracil
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
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
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.
Napabucasin
Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 8\~12 hours.
Napabucasin
Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 8\~12 hours.
Interventions
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Napabucasin
Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 8\~12 hours.
Fluorouracil
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
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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1Globe Health Institute LLC
INDUSTRY
Responsible Party
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Locations
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First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijng Cancer Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Nanfang Hospital
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat - sen University
Guangzhou, Guangdong, China
Forth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The 81 Hospital of the Chinese People's Liberation Army
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Provence Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Liaoning Provincial Cancer Hospital
Shenyang, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
The Affiliated Hospital Qingdao University
Qingdao, Shandong, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Ren Ji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi' AnJiaotong University
Xi’an, Shanxi, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
The Second Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Sir Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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STEMNESS-CRC
Identifier Type: -
Identifier Source: org_study_id
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