A Phase 2 interventional study of Regorafenib and UGT1A1 genotyping (TA6/TA6) in Metastatic Colorectal Cancer, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-03-21.
Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Phase 2, Interventional, and Treatment
A prospective, multicenter, randomized in a 2:1 ratio, controlled, clinical trial with two parallel arms will be conducted to compare irinotecan dose escalated FOLFIRI according to UGT1A1 genotyping plus 120 mg regorafenib with 120 mg regorafenib alone in previously treated patients with metastatic colorectal cancer (mCRC).
Primary objective:
Progression-free survival
Secondary objective:
Overall survival, best objective response, disease control rate, time to progression, duration of treatment and adverse events
Number of Subjects: 153 patients with metastatic colorectal cancer treated with regorafenib and FOLFIRI as a third- or fourth-line setting.
Plan of the Study:
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's planned enrollment of 153 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 288 studies on the registry; 57 are open to participants now.
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Women with childbearing potential must agree to perform adequate contraception measures since informed consent till a least 12 weeks after the last study drug administration.
The investigators or designee are requested to advise the patient to achieve adequate birth control.
Adequate organ and bone marrow function as defined below:
Exclusion Criteria:
Regimen for treatment consists of irinotecan (180 mg/m2 as a 120-min IV infusion for UGT1A1 genotyping (TA6/TA6) and UGT1A1 genotyping (TA6/TA7); 120 mg/m2 as a 120-min IV infusion for UGT1A1 genotyping (TA7/TA7)), followed by Leucovorin (400 mg/m2 IV infusion over 2 hours), and fluorouracil (5-FU) (2800 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks. After every 2 cycles of each different dose of irinotecan, if adverse events (AEs) are under the grade 2, we will escalate the dose of 30 mg/m2. The estimated maximal dose of irinotecan is 260 mg/m2 for UGT1A1 genotyping (TA6/TA6); 240 mg/m2 for UGT1A1 genotyping (TA6/TA7); 180 mg/m2 for UGT1A1 genotyping (TA7/TA7). Regorafenib is administered at adjusted dosage of 120 mg daily for 3 weeks in a 4-week cycle.
Drug: Regorafenib · Genetic: UGT1A1 genotyping (TA6/TA6) · Genetic: UGT1A1 genotyping (TA6/TA7) · Genetic: UGT1A1 genotyping (TA7/TA7) · Drug: Leucovorin and 5-FU
Regorafenib is administered at adjusted dosage of 120 mg daily for 3 weeks in a 4-week cycle.
Drug: Regorafenib
Regorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle
Also known as: stivarga
The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 260 mg/m2
The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 240 mg/m2
The dosage of irinotecan in FOLFIRI is escalated from 120mg/m2 to180 mg/m2
Drug pages: Leucovorin · Fluorouracil
Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period)
Progression-free survival
Time from treatment to disease progresses and lives
Time frame: From date of initiation of treatment until the date of first documented progression, assessed up to 23 months
Overall survival
Time from treatment to death of patients
Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 23 months
Best objective response
best response recorded during treatment
Time frame: From date of initiation of treatment until the date of disease progression, assessed up to 23 months
Disease control rate
Rate of best objective response, including complete response, partial response and stable disease
Time frame: From date of initiation of treatment until the date of disease progression, assessed up to 23 months
Time to progression
Time from treatment to disease progresses
Time frame: From date of initiation of treatment until the date of disease progression, assessed up to 23 months
Duration of treatment
Time from initiation to termination of treatment
Time frame: From date of initiation of treatment until the date of disease progression, assessed up to 23 months
Plan to share: No
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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