Phase I Study of Sulfatinib(HMPL-012) in Patients With Advanced Solid Tumors (HMPL)
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|ClinicalTrials.gov Identifier: NCT02133157|
Recruitment Status : Completed
First Posted : May 7, 2014
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tumor||Drug: Sulfatinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Safety and Pharmacokinetics of Sulfatinib(HMPL-012) in Patients With Advanced Solid Tumors|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Experimental: Sulfatinib capsule
cohort 1: Sulfatinib single oral dosing;after 7days,Sulfatinib continuous oral dosing ( once a day) 28days as a cycle.
Sulfatinib is a capsule in the form of25, 50mg , 100mg; oral, once a day
Other Name: HMPL-012
- To assess number of participants with adverse events as a measure of safety and tolerability during dose escalating [ Time Frame: 1-28days after every drug administration ]The primary endpoint is evaluation of safety during the first 28-day cycle 1 of therapy following the initiation of multiple dosing of HMPL-012. 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
- To measure the plasma concentration of HMPL-012 in single and repeated doses [ Time Frame: Day 1-3 Single Dose and Day 1-56 Steady State ]In the study of single-dose, full PK profiles of HMPL-012 will be obtained following administration of a single oral dose of HMPL-012 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 and pre-dose on days 56 of the cycle 2.
- Objective Response Rate [ Time Frame: every 4 weeks until 1 year ]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.
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): NCT02133157
|Academy of Military Medical Affiliated Hopital|
|Beijing, China, 100071|
|Principal Investigator:||Ming J Xu, PHD||Academy of Military Medical Affiliated Hopital|