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
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Condition or disease | Intervention/treatment | Phase |
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Colorectal Cancer | Drug: fruquintinib | Phase 1 Phase 2 |
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 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 |
Arm | Intervention/treatment |
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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
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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 |
- 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
- 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
- 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.
- 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
- 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
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
China, Guangdong | |
Sun Yat-sen University Cancer Center | |
Guangzhou, Guangdong, China, 510060 | |
China, Shanghai | |
Fudan University Cancer Center | |
Shanghai, Shanghai, China, 200032 |
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 |
patients with mCRC who failed 2nd therapy or more |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |