Fruquintinib Combined With TAS-102 in the Treatment of Patients With Advanced Metastatic CRC

Metastatic Colorectal Cancer Clinical Trial

Official title:

Phase II Study of Fruquintinib Combined With TAS-102 in the Treatment of Patients With Advanced Metastatic CRC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05004831
• Other study ID #: HMPL-013-FLAG-C106
• Status: Recruiting
• Phase: Phase 2
• Start date: March 11, 2022
• Est. completion date: September 2024

Study information

• Verified date: August 2022
• Source: Sun Yat-sen University
• Contact: Jianjun Peng, M.D.
• Phone: +8613602263939
• Email: pjianj[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II study aims to explore the efficacy and safety of fruquintinib combined with TAS-102 in the third-line treatment of patients with advanced metastatic colorectal cancer.

Description:

This is a prospective, single center, one-arm phase II study. A total of 54 advanced mCRC patients refractory to standard therapies will be enrolled and administered with fruquintinib (4mg/d, qd po, D1-21, Q4W) combined with TAS-102 (70mg/m2/d, bid po, D1-5, 8-12, Q4W) until intolerable toxicity, disease progression or death. Primary endpoint of this study is PFS and secondary endpoints are OS, ORR, DCR and safety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: September 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. = 18 and = 75 years of age;

2. Histological or cytological confirmed advanced metastatic colorectal cancer;

3. Refractory to at least second line standard treatment containing fluorouracil, oxaliplatin and irinotecan;

4. At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan or 20mm by conventional CT scan);

5. ECOG performance status of 0-1;

6. Life expectancy = 12 weeks;

7. No previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitor (TKI);

8. Signed and dated informed consent;

9. Adequate hepatic, renal, heart, and hematologic functions;

10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria:

1. Pregnant or lactating women;

2. Any factors that influence the usage of oral administration or any disease or condition that affects drug absorption;

3. Previous treatment with TAS-102;

4. Participated in clinical trials of other drugs within four weeks before enrollment;

5. Received other systemic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy;

6. International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN;

7. Clinically significant electrolyte abnormalities;

8. Subjected with hypertension that cannot be controlled by drugs, which is specified as:

systolic blood pressure = 140 mmHg and / or diastolic blood pressure = 90 mmHg;

9. Unrelieved toxic reactions higher than CTCAE V5.0 grade 1 caused by any previous anti-cancer treatment;

10. Incomplete healing of skin wound, surgical site, traumatic site, severe mucosal ulcer or fracture;

11. Conditions that may cause gastrointestinal bleeding and perforation determined by the researcher;

12. History of arterial thrombosis or deep venous thrombosis within 6 months before enrollment;

13. Stroke and / or transient cerebral ischemia occurred within 12 months before enrollment;

14. Cardiovascular diseases with significant clinical significance;

15. LVEF<50%;

16. Congestive heart failure New York Heart Association (NYHA) grade > 2;

17. Evidence of CNS metastasis;

18. Previous treatment with VEGFR inhibition;

19. Ventricular arrhythmias requiring drug treatment;

20. Proteinuria = 2+ (1.0g/24hr);

21. Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy;

22. Other malignant tumors in the past 5 years, except skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;

23. Active infection that is not controlled clinically, such as acute pneumonia, active hepatitis B or hepatitis C;

24. By judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• fruquintinib plus TAS-102
fruquintinib 4mg/d, qd po, D1-21, Q4W; TAS-102 70mg/m2/d, bid po, D1-5, 8-12, Q4W

Locations

Country	Name	City	State
China	the first affiliated hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression-free Survival	from randomization up to progressive disease or EOT due to any cause, up to 2 years
Secondary	OS	Overall Survival	from randomization until death due to any cause, assessed up to 3 years
Secondary	DCR	Disease Control Rate	from randomization up to progressive disease or EOT due to any cause, up to 2 years
Secondary	ORR	Objective Response Rate	from randomization up to progressive disease or EOT due to any cause, up to 2 years
Secondary	Safety and tolerance	Safety and tolerance evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0	from first dose to within 30 days after the last dose