Fruquintinib Plus Capecitabine as Maintenance Treatment of RAS / BRAF Wild-type Metastatic Colorectal Cancer

NCT05016869 | Unknown Phase 1

• 1 other identifier: HMPL-013-FLAG-C102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I/II study was designed to evaluate the efficacy and safety of fruquintinib combination with capecitabine in maintenance treatment after first-line chemotherapy combined with cetuximab.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• recommended phase 2 dose (RP2D)

  RP2D is determined according to DLT and MTD in the phase 1 study

  up to 1 year

• progression-free survival (PFS)

  PFS is defined as the time from the start of maintenance treatment to the earliest evidence of disease progression (per RECIST v1.1), or death from any cause

  up to 3 years

Secondary Outcomes (4)

• disease control rate (DCR)

  up to 3 years

• objective response rate (ORR)

  up to 3 years

• overall survival (OS)

  up to 3 years

• Adverse events (AEs)

  up to 3 years

Study Arms (1)

Experimental

EXPERIMENTAL

fruquintinib plus capecitabine

Drug: fruquintinib plus capecitabine

Interventions

fruquintinib plus capecitabine DRUG

Ⅰb: capecitabine: 1000 mg/m²，PO BID, d1-14，Q3W; fruquintinib 3mg/4mg/5mg, d1-14, PO QD, Q3W. ⅠⅠ: fruquintinib RP2D, d1-14, PO QD, Q3W, capecitabine: 1000 mg/m²，PO BID, d1-14，Q3W

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed metastatic colorectal adenocarcinoma;
• years old;
• Eastern Cooperation Oncology Group (ECOG) performance score 0-1;
• At least one evaluable lesion for disease assessment according to RECIST version 1.1;
• Able to take oral medications;
• Patient have achieved CR, PR or SD after up to 8 cycles of first-line standard FOLFOX / - FOLFIRI / XELOX / xeliri + cetuximab treatment, and remained unresectable;
• If radiotherapy has been performed before enrollment, at least one lesion should be located outside the radiation field;
• Adequate organ functions as assessed by the following laboratory requirements: Leukocytes≥3.0x10\^9/L, absolute neutrophil count≥1.5x10\^9/L, platelet count≥100x10\^9/L, hemoglobin≥9g/dL; serum bilirubin≤1.5x the upper limit of normal(ULN);Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)≤2.5x ULN; serum creatinine≤1.5x ULN.
• An expected survival of at least 12 weeks;
• Fertile male or female patients volunteered to use effective contraceptive methods during the study period and within 6 months after the end of treatment;
• Willing to provide written informed consent to study procedures.

You may not qualify if:

• Patients who have received fruquintinib;
• Patients who have received TACE within 6 weeks before enrollment;
• Participated in other unapproved or unlisted drug clinical trials in China within 4 weeks before enrollment, and received corresponding experimental drug treatment;
• Patients with dysphagia, active peptic ulcer, intestinal obstruction, active gastrointestinal bleeding, peptic perforation, malabsorption syndrome or uncontrolled intestinal inflammatory diseases;
• International normalized ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \> 1.5 × ULN；
• The researchers judged clinically significant electrolyte abnormalities;
• At present, the patient has hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg;
• Patients currently have poorly controlled diabetes (fasting glucose level is greater than CTCAE grade 2 after regular treatment);
• Have received any surgery or invasive treatment or operation within 4 weeks before enrollment (except venous catheterization, puncture and drainage, etc.);
• Active or uncontrolled severe infection ≥ grade 2 according to National Cancer Institute Common Toxicity (NCI-CTC) criteria;
• Uncontrolled central nervous system metastasis or previous brain metastasis;
• Other malignant tumors in the past 5 years, except for skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
• Any kind of concurrent cardiac disease with clinical meanings, such as cardiovascular accident, myocardial infarction, thromboembolism or hemorrhage within 6 months before enrollment, congestive heart failure ≤New York Heart Association (NYHA) class 2; ventricular arrhythmias requiring drug treatment; LVEF \< 50%;
• With positive urine protein and 24-hour urinary protein content\>1g;
• Have a tendency of bleeding or clotting;

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Center/Cancer Hospital, China Academy of Medical Science and Peking Union Medical College

Beijing, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

HMPL-013; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Lin Yang, M.D.

CONTACT

13681015148; lyang69@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 23, 2021
• Study Start: April 12, 2022
• Primary Completion: February 1, 2023
• Study Completion: August 1, 2024
• Last Updated: August 18, 2022

Record last verified: 2022-08

Locations

CN (1)