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A Phase Ib Study of Fruquintinib in 3rd Line mCRC

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ClinicalTrials.gov Identifier: NCT01975077
Recruitment Status : Completed
First Posted : November 3, 2013
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
Fudan University
Sun Yat-sen University
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Study Description
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Brief Summary:
Fruquintinib is a novel oral small molecule compound discovered and developed by Hutchison MediPharma that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor xenografts.Based on first-in-human study, both 4mg QD and 5mg 3wks on/1wk off are safety and efficacy, this phase Ib study is to evaluable the safety, tolerability and efficacy of these 2 regimens with mCRC failed 2nd therapy or more and to determine the recommended dose and regimen in phase II/III study.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: fruquintinib Phase 1 Phase 2

Detailed Description:

This is a phase Ib, randomize, interventional, open-label, multicenter study to provide fruquintinib to subjects diagnosed with metastatic colorectal cancer who have failed after standard therapy and for whom no therapy alternatives exist.

The primary endpoint of this study will be safety.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Phase Ib Trial of Fruquintinib "4mg Once Daily Continuous"Versus "5mg Once Daily 3wks on/1wk Off" in Patients With Metastatic Colorectal Carcinoma as 3rd Therapy
Study Start Date : December 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : October 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: A- 4mg QD
arm A- fruquintinib 4mg once daily, p.o.,continuous;given in 28-days cycles until disease progress, intolerable toxicity or patients withdrawal of consent
 Drug: fruquintinib
Fruquintinib is a capsule in the form of 1mg and 5mg, orally, daily
Other Name: HMPL-013
Experimental: B- 5mg once daily, 3wks on/1wk off
arm B-fruquintinb 5mg once daily,p.o.,3 weeks on/1 week off, given in 28-day cycles until disease progress,intolerable toxicity or patients withdrawal of consent
 Drug: fruquintinib
Fruquintinib is a capsule in the form of 1mg and 5mg, orally, daily
Other Name: HMPL-013


Outcome Measures
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Primary Outcome Measures :
  1. safety and tolerability [ Time Frame: from day 1 of first dosing to 30days after permanent discontinuation of HMPL-013 ]
    The primary objective is evaluation of safety and tolerabilty with 2 regimens. The primary endpoint is the incidence of AEs, SAEs, Gr3/4 AEs and AEs led to dose interruption and dose discontinued


Secondary Outcome Measures :
  1. objective response rate(ORR) [ Time Frame: every 8 weeks until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months ]
    using RECIST version 1.1

  2. pharmacokinetic profiles [ Time Frame: Day 1-84 steady state ]

    At QD regimen, PK sampling will include a pre-dose and at the 1,2,4,8,24 hour time points on day 1 and day 21;a pre-dose and at the 2 hour time point on day 28,42,70,84.

    At 3wks on/1wk off regimen,PK sampling will include a pre-dose and at the 1,2,4,8,24 hour time points on day 1 and day 21; a pre-dose and at the 2 hour time point on day 42 and day 70; only pre-dose on day 28,56,84.


  3. disease control rate (DCR) [ Time Frame: every 8 weeks until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months ]
    using RECIST version 1.1

  4. progression-free survival (PFS) [ Time Frame: every 8 weeks until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months ]
    using RECIST version 1.1

  5. overall survival (OS) [ Time Frame: every 2 months since end of treatment ]
    from first dosing until death due to any cause, assessed up to 2 years


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 and ≤ 70 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

Exclusion Criteria:

  • 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)
  • Uncontrolled hemorrhage in GI
  • 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
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): NCT01975077


Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
China, Shanghai
Fudan University Cancer Center
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Hutchison Medipharma Limited
Fudan University
Sun Yat-sen University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT01975077    
Other Study ID Numbers: 2012-013-00CH3
First Posted: November 3, 2013    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2019
Keywords provided by Hutchison Medipharma Limited:
patients with mCRC who failed 2nd therapy or more
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