Colorectal CancerPhase 1/2NCT01975077
A Phase Ib Study of Fruquintinib in 3rd Line mCRC
A Phase 1/2 study testing fruquintinib in people with Colorectal Cancer, run by Hutchison Medipharma Limited at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- fruquintinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2012to Oct 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Fudan University Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- fruquintinib
- Keywords
- patients with mCRC who failed 2nd therapy or more
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fruquintinibDrug
Also called HMPL-013
Fruquintinib is a capsule in the form of 1mg and 5mg, orally, daily
| Study group | Role | What they receive |
|---|---|---|
| A- 4mg QD | Experimental | arm A- fruquintinib 4mg once daily, p.o.,continuous;given in 28-days cycles until disease progress, intolerable toxicity or patients withdrawal of consent Receives: Drug: fruquintinib |
| B- 5mg once daily, 3wks on/1wk off | Experimental | 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 Receives: Drug: fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability
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
Measured: from day 1 of first dosing to 30days after permanent discontinuation of HMPL-013
Secondary outcomes (5)
objective response rate(ORR)
using RECIST version 1.1
Measured: 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
pharmacokinetic profiles
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.
Measured: Day 1-84 steady state
disease control rate (DCR)
using RECIST version 1.1
Measured: 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
progression-free survival (PFS)
using RECIST version 1.1
Measured: 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
overall survival (OS)
from first dosing until death due to any cause, assessed up to 2 years
Measured: every 2 months since end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startDec 2012
- Primary completionApr 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University, Sun Yat-sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975077
- Sponsor's protocol ID
- 2012-013-00CH3
- Status last verified
- Feb 2019
- First submitted
- 29 Sep 2013
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xu RH, Li J, Bai Y, Xu J, Liu T, Shen L, Wang L, Pan H, Cao J, Zhang D, Fan S, Hua Y, Su W. Safety and efficacy of fruquintinib in patients with previously treated metastatic colorectal cancer: a phase Ib study and a randomized double-blind phase II study. J Hematol Oncol. 2017 Jan 19;10(1):22. doi: 10.1186/s13045-016-0384-9.
PubMed 28103904
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01975077
- Acronym / sponsor ID
- 2012-013-00CH3
- Conditions
- Colorectal Cancer
- Keywords
- patients with mCRC who failed 2nd therapy or more
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Fudan University, Sun Yat-sen University
- Study start
- Dec 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A- 4mg QD | Experimental | Drug: fruquintinibarm A- fruquintinib 4mg once daily, p.o.,continuous;given in 28-days cycles until disease progress, intolerable toxicity or patients withdrawal of consent |
| B- 5mg once daily, 3wks on/1wk off | Experimental | Drug: fruquintinibarm 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fruquintinibAlso: HMPL-013Fruquintinib is a capsule in the form of 1mg and 5mg, orally, daily | Drug | A- 4mg QD, B- 5mg once daily, 3wks on/1wk off |
Primary outcome
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
5 secondary outcomes
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
pharmacokinetic profiles
Time frame: Day 1-84 steady state
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
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
overall survival (OS)
Time frame: every 2 months since end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Derived from this study: PubMed 28103904Xu RH, Li J, Bai Y, Xu J, Liu T, Shen L, Wang L, Pan H, Cao J, Zhang D, Fan S, Hua Y, Su W. Safety and efficacy of fruquintinib in patients with previously treated metastatic colorectal cancer: a phase Ib study and a randomized double-blind phase II study. J Hematol Oncol. 2017 Jan 19;10(1):22. doi: 10.1186/s13045-016-0384-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing fruquintinib in people with Colorectal Cancer, run by Hutchison Medipharma Limited at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and tolerability (time frame: from day 1 of first dosing to 30days after permanent discontinuation of HMPL-013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01975077, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.