A Phase II Study on Dose Optimization of Fruquintinib in Elderly mCRC Patients Refractory to Standard Treatment（DOFEMCRC）

NCT ID: NCT05025631

Last Updated: 2023-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-06
• Study Completion Date: 2022-10-30

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fruquintinib dose-optimization

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.

Group Type: EXPERIMENTAL

Fruquintinib

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 65 years and older;

2. Histologically or cytologically confirmed unresectable metastatic colorectal cancer refractory to or unfit for standard therapies;

3. ECOG PS 0-1;

4. 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;

5. Life expectancy ≥ 3 months;

6. Cooperative in observation of adverse events and curative effect;

7. No other anti-tumor concomitant treatment (including steroid drugs);

8. Adequate organ and bone marrow functions;

9. At least one measurable lesion(s);

10. Signed the written informed consent and completed the geriatric questionnaire (G8 screening form) at the time of enrollment.

Exclusion Criteria

1. Active upper gastrointestinal ulcer, obvious vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc which may affect drug absorption, distribution, metabolism, or clearance;

2. Evidence of central nervous system metastasis;

3. One of the following complications: uncontrolled hypertension, coronary artery disease, arrhythmia and heart failure;

4. Abuse of alcohol or drugs;

5. Less than 4 weeks from the last clinical trial;

6. Previous treatment with VEGFR inhibitors;

7. Severe uncontrolled disability with concurrent infection;

8. Proteinuria ≥ 2 + (1.0g / 24hr);

9. Uncontrollable gastrointestinal bleeding;

10. Arterial / venous thromboembolic events such as cerebrovascular accident (including transient ischemic attack) occurred within 12 months before the first dose;

11. Acute myocardial infarction, acute coronary syndrome or coronary artery bypass grafting occurred within 6 months before the first dose;

12. Fracture or wound that has not been cured for a long time;

13. Coagulation dysfunction, bleeding tendency or receiving anticoagulation treatment;

14. Congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (HBV DNA ≥ 103copies / ml after regular antiviral therapy);

15. Patients who are not suitable for the study judged by the researchers.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhen-Yu Ding

OTHER

Sponsor Role: lead

Responsible Party

Zhen-Yu Ding

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

China West Hospital

Chengdu, Sichuan, China

Countries

China

Other Identifiers

HMPL-013-FLAG-C110

Identifier Type: -

Identifier Source: org_study_id