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| Name | Class |
|---|---|
| Fudan University | OTHER |
| Sun Yat-sen University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fruquintinib | Drug | Fruquintinib is a capsule in the form of 1mg and 5mg, orally, daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from day 1 of first dosing to 30days after permanent discontinuation of HMPL-013 |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate(ORR) | using RECIST version 1.1 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China | ||
| Fudan University Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28103904 | Derived | 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. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000591844 | HMPL-013 |
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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.
| Day 1-84 steady state |
| disease control rate (DCR) | using RECIST version 1.1 | 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 | 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 | every 2 months since end of treatment |
| Shanghai |
| Shanghai Municipality |
| 200032 |
| China |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |