Back to resultsA Phase II Study on Dose Optimization of Fruquintinib in Elderly mCRC Patients Refractory to Standard Treatment（DOFEMCRC） (DOFEMCRC)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fruquintinib
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- 65 years and older;
- Histologically or cytologically confirmed unresectable metastatic colorectal cancer refractory to or unfit for standard therapies;
- ECOG PS 0-1;
- At least 4 weeks after the last anti-tumor therapy (chemotherapy, radiotherapy, biotherapy or hormone therapy) and more than 3 months after operation treatment before enrollment;
- Life expectancy ≥ 3 months;
- Cooperative in observation of adverse events and curative effect;
- No other anti-tumor concomitant treatment (including steroid drugs);
- Adequate organ and bone marrow functions;
- At least one measurable lesion(s);
- Signed the written informed consent and completed the geriatric questionnaire (G8 screening form) at the time of enrollment.
Exclusion Criteria:
- Active upper gastrointestinal ulcer, obvious vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc which may affect drug absorption, distribution, metabolism, or clearance;
- Evidence of central nervous system metastasis;
- One of the following complications: uncontrolled hypertension, coronary artery disease, arrhythmia and heart failure;
- Abuse of alcohol or drugs;
- Less than 4 weeks from the last clinical trial;
- Previous treatment with VEGFR inhibitors;
- Severe uncontrolled disability with concurrent infection;
- Proteinuria ≥ 2 + (1.0g / 24hr);
- Uncontrollable gastrointestinal bleeding;
- Arterial / venous thromboembolic events such as cerebrovascular accident (including transient ischemic attack) occurred within 12 months before the first dose;
- Acute myocardial infarction, acute coronary syndrome or coronary artery bypass grafting occurred within 6 months before the first dose;
- Fracture or wound that has not been cured for a long time;
- Coagulation dysfunction, bleeding tendency or receiving anticoagulation treatment;
- Congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (HBV DNA ≥ 103copies / ml after regular antiviral therapy);
- Patients who are not suitable for the study judged by the researchers.
Sites / Locations
- China West Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fruquintinib dose-optimization
Arm Description
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.
Outcomes
Primary Outcome Measures
PFS
Progression-free survival is determined from the date of treatment to PD or death from any cause
Secondary Outcome Measures
Safety and tolerability
Version 5.0 and AEs leading to dose interruption or discontinuation.
ORR
Objective Response Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
DCR
Disease Control Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
OS
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
Correlation between geriatric assessment and efficacy and safety
Statistical results obtained by analyzing the patient's geriatric assessment against efficacy and safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05025631
Brief Title
A Phase II Study on Dose Optimization of Fruquintinib in Elderly mCRC Patients Refractory to Standard Treatment（DOFEMCRC）
Acronym
DOFEMCRC
Official Title
A Phase II Study on Dose Optimization of Fruquintinib in Elderly Metastatic Colorectal Cancer Patients Refractory to Standard Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 6, 2020 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhen-Yu Ding
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A Phase II study on dose optimization of fruquintinib in elderly metastatic colorectal cancer patients refractory to standard treatment.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fruquintinib dose-optimization
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fruquintinib
Intervention Description
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.
Primary Outcome Measure Information:
Title
PFS
Description
Progression-free survival is determined from the date of treatment to PD or death from any cause
Time Frame
about a year
Secondary Outcome Measure Information:
Title
Safety and tolerability
Description
Version 5.0 and AEs leading to dose interruption or discontinuation.
Time Frame
about a year
Title
ORR
Description
Objective Response Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Time Frame
about a year
Title
DCR
Description
Disease Control Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Time Frame
about a year
Title
OS
Description
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
Title
Correlation between geriatric assessment and efficacy and safety
Description
Statistical results obtained by analyzing the patient's geriatric assessment against efficacy and safety
Time Frame
about a year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
65 years and older;
Histologically or cytologically confirmed unresectable metastatic colorectal cancer refractory to or unfit for standard therapies;
ECOG PS 0-1;
At least 4 weeks after the last anti-tumor therapy (chemotherapy, radiotherapy, biotherapy or hormone therapy) and more than 3 months after operation treatment before enrollment;
Life expectancy ≥ 3 months;
Cooperative in observation of adverse events and curative effect;
No other anti-tumor concomitant treatment (including steroid drugs);
Adequate organ and bone marrow functions;
At least one measurable lesion(s);
Signed the written informed consent and completed the geriatric questionnaire (G8 screening form) at the time of enrollment.
Exclusion Criteria:
Active upper gastrointestinal ulcer, obvious vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc which may affect drug absorption, distribution, metabolism, or clearance;
Evidence of central nervous system metastasis;
One of the following complications: uncontrolled hypertension, coronary artery disease, arrhythmia and heart failure;
Abuse of alcohol or drugs;
Less than 4 weeks from the last clinical trial;
Previous treatment with VEGFR inhibitors;
Severe uncontrolled disability with concurrent infection;
Proteinuria ≥ 2 + (1.0g / 24hr);
Uncontrollable gastrointestinal bleeding;
Arterial / venous thromboembolic events such as cerebrovascular accident (including transient ischemic attack) occurred within 12 months before the first dose;
Acute myocardial infarction, acute coronary syndrome or coronary artery bypass grafting occurred within 6 months before the first dose;
Fracture or wound that has not been cured for a long time;
Coagulation dysfunction, bleeding tendency or receiving anticoagulation treatment;
Congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (HBV DNA ≥ 103copies / ml after regular antiviral therapy);
Patients who are not suitable for the study judged by the researchers.
Facility Information:
Facility Name
China West Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study on Dose Optimization of Fruquintinib in Elderly mCRC Patients Refractory to Standard Treatment（DOFEMCRC）
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