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A Phase III Trial Evaluating Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients （FRESCO)

NCT02314819 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2020-02-17

No results posted yet for this study

Summary

Fruquintinib administered at 5mg once daily(QD) in 4 weeks treatment cycle (three weeks on and one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with metastatic colorectal cancer (CRC) in phase Ib and phase 2 study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of patients with metastatic CRC who have progressed after second line or above standard chemotherapy

Conditions

Interventions

DRUG

fruquintinib

fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off

DRUG

placebo

fruquintinib placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Eighty-One Hospital of People's Liberation Army

    collaborator OTHER

  • Hutchison Medipharma Limited

    lead INDUSTRY

Principal Investigators

  • Jin Li, PhD, MD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-01-31
Completion
2017-01-17

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02314819 on ClinicalTrials.gov