NCT02314819

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P50-P75 for phase_3 colorectal-cancer

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_3 colorectal-cancer

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2017

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2019

Enrollment Period

2.1 years

First QC Date

December 8, 2014

Last Update Submit

February 13, 2020

Conditions

Colorectal Cancer

Keywords

colorectal cancer

Outcome Measures

Primary Outcomes (1)

  • overall survival

    every two months after end of treatment (EOT) observation period at 30 days after the last medication

    from randomization until death due to any cause, assessed up to 2 year

Secondary Outcomes (4)

  • progression free survival

    from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year

  • Objective Response Rate (ORR)

    from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year

  • Disease Control Rate (DCR)

    from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year

  • Safety and tolerance evaluated by incidence, severity and outcomes of AEs

    from first dose to within 30 days after the last dose

Study Arms (2)

treatment arm

ACTIVE COMPARATOR

treatment arm- subjects will receive Fruquintinib 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.

Drug: fruquintinib

control arm

PLACEBO COMPARATOR

control arm- subjects will receive Fruquintinib placebo 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.

Drug: placebo

Interventions

fruquintinibDRUG

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

Also known as: HMPL-013
treatment arm
placeboDRUG

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

Also known as: HMPL-013 placebo
control arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 and ≤ 75 years of age , with ≥ 40Kg
  • Histological or cytological confirmed colorectal cancer
  • ECOG performance status of 0-1
  • Standard regimen failed or no standard regimen available
  • Adequate hepatic, renal, heart, and hematologic functions
  • At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
  • Signed and dated informed consent
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure

You may not qualify if:

  • \- Pregnant or lactating women
  • Any factors that influence the usage of oral administration
  • Evidence of CNS metastasis
  • Intercurrence with one of the following: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure
  • Abuse of alcohol or drugs
  • Less than 4 weeks from the last clinical trial - Previous treatment with VEGFR inhibition
  • Disability of serious uncontrolled intercurrence infection
  • Proteinuria ≥ 2+ (1.0g/24hr)
  • Have evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness
  • Within 12 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc.
  • Within 6 months before the first treatment occurs acute myocardial infarction, acute coronary syndrome or CABG
  • Bone fracture or wounds that was not cured for a long time
  • Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Hutchison Medi Pharma Investigational Site

Hefei, Anhui, 230000, China

Location

Hutchison Medi pharma Investigational Site

Beijing, Beijing Municipality, 100071, China

Location

Hutchison Medi Pharma Investigational Site

Guangzhou, Guangdong, 510000, China

Location

Hutchison Medi Pharma investigational site

Shenzhen, Guangdong, 518036, China

Location

Hutchison Medi Pharma Investigational Site

Liuchow, Guangxi, 545005, China

Location

Hutchison Medi Pharma Investigational Site

Harbin, Heilongjiang, 150081, China

Location

Hutchison Medi Pharma Investigational Site

Changsha, Hunan, 410013, China

Location

Hutchison Medi Pharma Investigational Site

Changzhou, Jiangsu, 213000, China

Location

Hutchison Medi Pharma Investigational Site

Nanjing, Jiangsu, 210000, China

Location

Hutchison Medi Pharma Investigational Site

Nantong, Jiangsu, 226000, China

Location

Hutchison Medi Pharma Investigational Site

Xuzhou, Jiangsu, 221000, China

Location

Hutchison Medi Pharma Investigational Site

Changchun, Jilin, 130000, China

Location

Hutchison Medi Pharma Investigational Site

Qingdao, Shandong, 266000, China

Location

Hutchison Medi Pharma Investigational Site

Shanghai, Shanghai Municipality, 200032, China

Location

Hutchison Medi Pharma Investigational Site

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (4)

  • Li J, Qin S, Xu RH, Shen L, Xu J, Bai Y, Yang L, Deng Y, Chen ZD, Zhong H, Pan H, Guo W, Shu Y, Yuan Y, Zhou J, Xu N, Liu T, Ma D, Wu C, Cheng Y, Chen D, Li W, Sun S, Yu Z, Cao P, Chen H, Wang J, Wang S, Wang H, Fan S, Hua Y, Su W. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018 Jun 26;319(24):2486-2496. doi: 10.1001/jama.2018.7855.

    PMID: 29946728RESULT

  • Qin S, Xu RH, Shen L, Xu J, Bai Y, Yang L, Deng Y, Chen ZD, Zhong H, Pan H, Guo W, Shu Y, Yuan Y, Zhou J, Xu N, Liu T, Ma D, Wu C, Cheng Y, Chen D, Li W, Sun S, Yu Z, Cao P, Chen H, Wang J, Wang S, Wang H, Wang N, Zhang B, Zhang Q, Su W, Guo X, Li J. Subgroup Analysis by Liver Metastasis in the FRESCO Trial Comparing Fruquintinib versus Placebo Plus Best Supportive Care in Chinese Patients with Metastatic Colorectal Cancer. Onco Targets Ther. 2021 Aug 11;14:4439-4450. doi: 10.2147/OTT.S307273. eCollection 2021.

    PMID: 34408440DERIVED

  • Xu R, Qin S, Guo W, Bai Y, Deng Y, Yang L, Chen Z, Zhong H, Pan H, Shu Y, Yuan Y, Zhou J, Xu N, Liu T, Ma D, Wu C, Cheng Y, Xu J, Chen D, Li W, Sun S, Yu Z, Cao P, Li J, Chen H, Wang J, Wang S, Wang H, Wang N, Zhang B, Han R, Su W, Guo X, Li J. Subgroup analysis by prior anti-VEGF or anti-EGFR target therapy in FRESCO, a randomized, double-blind, Phase III trial. Future Oncol. 2021 Apr;17(11):1339-1350. doi: 10.2217/fon-2020-0875. Epub 2020 Dec 16.

    PMID: 33325251DERIVED

  • Li J, Guo W, Bai Y, Deng Y, Yang L, Chen Z, Zhong H, Xu R, Pan H, Shu Y, Yuan Y, Zhou J, Xu N, Liu T, Ma D, Wu C, Cheng Y, Xu J, Chen D, Li W, Sun S, Yu Z, Cao P, Shen L, Chen H, Wang S, Wang H, Fan S, Guo X, Wang N, Han R, Zhang B, Qin S. Safety Profile and Adverse Events of Special Interest for Fruquintinib in Chinese Patients with Previously Treated Metastatic Colorectal Cancer: Analysis of the Phase 3 FRESCO Trial. Adv Ther. 2020 Nov;37(11):4585-4598. doi: 10.1007/s12325-020-01477-w. Epub 2020 Sep 8.

    PMID: 32901330DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

HMPL-013

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jin Li, PhD, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 11, 2014

Study Start

December 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 17, 2017

Last Updated

February 17, 2020

Record last verified: 2019-02

Locations

CN(15)