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

Colorectal Cancer Clinical Trial

— DOFEMCRC  

Official title:

A Phase II Study on Dose Optimization of Fruquintinib in Elderly Metastatic Colorectal Cancer Patients Refractory to Standard Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05025631
• Other study ID #: HMPL-013-FLAG-C110
• Status: Completed
• Phase: Phase 2
• Start date: November 6, 2020
• Est. completion date: October 30, 2022

Study information

• Verified date: April 2023
• Source: Sichuan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase II study on dose optimization of fruquintinib in elderly metastatic colorectal cancer patients refractory to standard treatment.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	China West Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Zhen-Yu Ding

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression-free survival is determined from the date of treatment to PD or death from any cause	about a year
Secondary	Safety and tolerability	Version 5.0 and AEs leading to dose interruption or discontinuation.	about a year
Secondary	ORR	Objective Response Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1	about a year
Secondary	DCR	Disease Control Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1	about a year
Secondary	OS	OS is the time interval from the start of treatment to death due to any reason or lost of follow-up	about a year
Secondary	Correlation between geriatric assessment and efficacy and safety	Statistical results obtained by analyzing the patient's geriatric assessment against efficacy and safety	about a year