Phase I Study of Fruquintinib(HMPL-013) in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01645215|
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tumor||Drug: Fruquintinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Safety and Pharmacokinetics of Fruquintinib(HMPL-013) in Patients With Advanced Solid Tumors|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Experimental: Fruquintinib capsule
cohort 1: fruquintinb continuous oral dosing (1mg once a day) cohort 2: fruquintinb continuous oral dosing (2mg once a day) cohort 3: fruquintinb continuous oral dosing (4mg once a day) cohort 4: fruquintinb continuous oral dosing (6mg once a day) cohort 5: fruquintinb continuous oral dosing (5mg once a day) cohort 6: fruquintinb oral dosing, 3 weeks on/1 week off (5mg once a day) cohort 7: fruquintinb oral dosing, 3 weeks on/1 week off (6mg once a day)
Fruquintinib is a capsule in the form of 0.25mg , 1mg and 5mg, oral, once a day.
Other Name: HMPL-013
- Safety in the first 28-Days of Therapy [ Time Frame: 28-Days after Permanent Discontinuation of HMPL-013 ]The primary endpoint is evaluation of safety during the first 28-day cycle of therapy following the initiation of multiple dosing of HMPL-013. The safety variables to be evaluated in this study are adverse events, physical examinations, vital signs (specifically including blood pressure), clinical laboratory evaluations including serum chemistry, hematology , and urinalysis (with detailed sediment analysis, proteinuria, and 24-hour urine for collection for protein), and electrocardiograms (ECGs) in triplicate.
- Objective Response Rate （ORR) [ Time Frame: every 8 weeks until end of treatment ]Anti-tumoral efficacy will be assessed by best radiographic response based on Response Evaluation Criteria in Solid Tumors (RECIST v 1.0) at baseline (Day -14 to -1) and at the end of two 28-Day cycles of therapy . For patients that continue on repeat 28-Day cycles after the primary evaluation period, progression will be assessed after each two 28-Day cycles of therapy.
- Pharmacokinetic Assessments for AUC, Cmax and Tmax [ Time Frame: Day 1-3 Single Dose and Day 1-28 Steady State ]In the study of single-dose, full PK profiles of HMPL-013 will be obtained following administration of a single oral dose of HMPL-013 on Day 1 to Day 3. At multiple-dose, PK sampling will include a pre-dose and at the 1,4,8,12 hour time points on days 1,14,28 of dosing in the first 28-Day cycle of therapy, and pre-dose on days 2, 3, 7, 15 and 29 of the first 28-Day cycle of 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): NCT01645215
|Fudan University Cancer Center|
|Shanghai, Shanghai, China, 200032|