A Phase III Clinical Study of Napabucasin (GB201) Plus FOLFIRI in Adult Patients With Metastatic Colorectal Cancer
Previously Treated Metastatic Colorectal Cancer
About this trial
This is an interventional treatment trial for Previously Treated Metastatic Colorectal Cancer focused on measuring CRC
Eligibility Criteria
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
Sites / Locations
- First Affiliated Hospital of Bengbu Medical CollegeRecruiting
- The First Affiliated Hospital of Anhui Medical UniversityRecruiting
- The Second Affiliated Hospital of Anhui Medical UniversityRecruiting
- Cancer Hospital Chinese Academy of Medical SciencesRecruiting
- Beijng Cancer HospitalRecruiting
- Chinese PLA General HospitalRecruiting
- Fujian Medical University Union HospitalRecruiting
- Sun Yat-sen University Cancer CenterRecruiting
- Guangdong General HospitalRecruiting
- Nanfang HospitalRecruiting
- The Sixth Affiliated Hospital of Sun Yat - sen UniversityRecruiting
- Forth Hospital of Hebei Medical UniversityRecruiting
- Harbin Medical University Cancer HospitalRecruiting
- Henan Cancer HospitalRecruiting
- First Affiliated Hospital of Zhengzhou UniversityRecruiting
- Union Hospital of Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
- Tongji Hospital of Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
- Hunan Cancer Hospital
- The 81 Hospital of the Chinese People's Liberation ArmyRecruiting
- Nanjing Drum Tower HospitalRecruiting
- Jiangsu Cancer HospitalRecruiting
- Jiangsu Provence HospitalRecruiting
- The First Affiliated Hospital of Nanchang UniversityRecruiting
- Jilin Cancer HospitalRecruiting
- The First Bethune Hospital of Jilin UniversityRecruiting
- Liaoning Provincial Cancer HospitalRecruiting
- Shandong Cancer HospitalRecruiting
- The Affiliated Hospital Qingdao UniversityRecruiting
- Shanghai General HospitalRecruiting
- Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
- Shanghai East HospitalRecruiting
- Ren Ji Hospital, Shanghai Jiaotong University School of MedicineRecruiting
- The First Affiliated Hospital of Xi' AnJiaotong UniversityRecruiting
- The First Affiliated Hospital, Zhejiang UniversityRecruiting
- The Second Affiliated Hospital, Zhejiang UniversityRecruiting
- Sir Run Shaw Hospital, School of Medicine, Zhejiang UniversityRecruiting
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Napabucasin plus FOLFIRI
Napabucasin
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 240 mg will be administered orally, twice daily, with doses separated by approximately 8~12 hours.