A Phase 2 interventional study of Fruquintinib in Colorectal Cancer, sponsored by Zhen-Yu Ding. Completed at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-04-28.
Sponsored by Zhen-Yu Ding · Phase 2, Interventional, and Treatment
A Phase II study on dose optimization of fruquintinib in elderly metastatic colorectal cancer patients refractory to standard treatment.
This is a prospective, multi-center, single arm, phase II study. In this study, the low-dose initial dose incremental optimization scheme was used in the first cycle in patients ≥65 years old who need to receive fruquintinib. The aim is to observe the safety, tolerability and efficacy of fruquintinib in elderly patients with mCRC refractory to standard treatment. The correlation between the efficacy, toxicity and geriatric evaluation of fruquintinib will also be analysed.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's enrollment of 29 is below the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Zhen-Yu Ding is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Fruquintinib was administered orally on 21 consecutive days in a 28-day treatment cycle. All patients were dose-optimized for the first cycle of fruquintinib - oral fruquintinib 3 mg/day in the first week; if tolerated, oral fruquintinib 4 mg/day in the second week; if still tolerated, then the dose was increased to 5 mg/day in the third week. From the second cycle, patients were given the maximum dose that they have tolerated in the first cycle.
Drug: Fruquintinib
Fruquintinib was administered for 21 consecutive days of a 28-day treatment cycle. The starting dose of fruquintinib was 3 mg/day, weekly incremental dose escalation occurred up to the maximum of 5 mg/day if no significant drug-related toxicities were observed. The highest tolerated dose from cycle 1 would be administered in cycle 2 and all subsequent cycles.
PFS
Progression-free survival is determined from the date of treatment to PD or death from any cause
Time frame: about a year
Safety and tolerability
Version 5.0 and AEs leading to dose interruption or discontinuation.
Time frame: about a year
ORR
Objective Response Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Time frame: about a year
DCR
Disease Control Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Time frame: about a year
OS
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
Time frame: about a year
Correlation between geriatric assessment and efficacy and safety
Statistical results obtained by analyzing the patient's geriatric assessment against efficacy and safety
Time frame: about a year
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Zhen-Yu Ding