Colorectal cance
Conditions
Interventions
Standard Dosing(Group A)
Fruquintinib 5 mg once daily for 21 days, followed by 7 days off, repeated every cycle.
Dose-Escalation Dosing (Group B)
Fruquintinib 3-5 mg once daily for 21 days, followed b
Sponsors
Taniguchi Hiroya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed colorectal adenocarcinoma. 2)Unresectable Stage IV or recurrent colorectal cancer. 3)Age =>18 years on the date of consent. 4)ECOG PS 0-2(Phase II part: 0-1 only). 5)With measurable lesion(not required for Phase III part). 6)Refractory, intolerant,or unsuitable for standard treatments including fluoropyrimidine,oxaliplatin,irinotecan,anti-VEGF antibody,and anti-EGFR antibody (if indicated). Previous administration of trifluridine/tipiracil or regorafenib is not mandatory 7)No previous administration with fruquintinib 8)Ability to safely receive the protocol treatment. 9)Written informed consent obtained from the patient.
Exclusion criteria
Exclusion criteria: 1)Pregnant or breastfeeding women, women who may be pregnant, or those not willing to use contraception. 2)Judged ineligible for trial participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| P2:Disease control rate, P3:Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| P2:Objective response rate, 12-week treatment continuation rate, Adverse events, Dose intensity, Plasma drug concentration, Patient-reported outcomes (PRO), QOL P3:Progression-free survival, Response rate, Disease control rate, Time to treatment failure, 12-week treatment continuation rate, Adverse events, Grade =>3 adverse events, Treatment-related serious adverse events, Dose intensity, Plasma drug concentration, Cumulative dose of fruquintinib, PRO, QOL | — |
Contacts
Public ContactHiroyuki Kodama
Osaka Medical and Pharmaceutical University Hospital
Outcome results
None listed