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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05004831
Recruitment Status : Recruiting
First Posted : August 13, 2021
Last Update Posted : August 18, 2022
Sponsor:
Information provided by (Responsible Party):
Peng Jian-jun, Sun Yat-sen University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: fruquintinib plus TAS-102 Phase 2

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Fruquintinib Combined With TAS-102 in the Treatment of Patients With Advanced Metastatic CRC
Actual Study Start Date : March 11, 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: fruquintinib plus TAS-102
fruquintinib plus TAS-102, orally given, Q4W
 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


Outcome Measures
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Primary Outcome Measures :
  1. PFS [ Time Frame: from randomization up to progressive disease or EOT due to any cause, up to 2 years ]
    Progression-free Survival


Secondary Outcome Measures :
  1. OS [ Time Frame: from randomization until death due to any cause, assessed up to 3 years ]
    Overall Survival

  2. DCR [ Time Frame: from randomization up to progressive disease or EOT due to any cause, up to 2 years ]
    Disease Control Rate

  3. ORR [ Time Frame: from randomization up to progressive disease or EOT due to any cause, up to 2 years ]
    Objective Response Rate

  4. Safety and tolerance [ Time Frame: from first dose to within 30 days after the last dose ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05004831


Contacts
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Contact: Jianjun Peng, M.D. +8613602263939 pjianj@mail.sysu.edu.cn

Locations
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China, Guangdong
the first affiliated hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: JIANJUN PENG, PhD    86-20-87332200 ext 8211    aidigua@hotmail.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Jianjun Peng, M.D. First Affiliated Hospital, Sun Yat-Sen University
More Information
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Responsible Party: Peng Jian-jun, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT05004831    
Other Study ID Numbers: HMPL-013-FLAG-C106
First Posted: August 13, 2021    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases