Phase I Study of the Volitinib (HMPL-504) in Patients With Advanced Solid Tumors (HMPL-504)
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|ClinicalTrials.gov Identifier: NCT01985555|
Recruitment Status : Completed
First Posted : November 15, 2013
Last Update Posted : July 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tumors||Drug: Volitinib(HMPL-504)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open-label, Multicenter Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of Volitinib in Patients With Advanced Solid Tumors|
|Actual Study Start Date :||May 2013|
|Actual Primary Completion Date :||April 2019|
|Actual Study Completion Date :||April 2019|
There are 5 dose cohorts,including600 QD,800QD and 400BID mg,500BID in the dose escalation stage and HMPL-504 will be administered orally to patients once daily for each dose cohort., in the dose expansion stage 500BID will be administered orally to patients.
Volitinib(HMPL-504) is a tablet in the form of 25 mg ,100mg and 200 mg,oral,once daily or 2 times a day.
- The primary endpoint is evaluation of safety and tolerability during all the study of therapy following the initiation of multiple dosing of Volitinib (HMPL-504). [ Time Frame: up to 20 months ]The primary endpoint is evaluation of safety and tolerability during all the study of therapy following the initiation of multiple dosing of HMPL-504. The safety and tolerability 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(Maximum Tolerated Dose) , and urinalysis (with detailed sediment analysis, proteinuria, and 24-hour urine for collection for protein), and electrocardiograms (ECGs) in triplicate,Incidence and nature of DLTs(Dose-Limiting Toxicity),To determine the MTD (Maximum Tolerated Dose).
- Pharmacokinetic Assessments for area under curve (AUC), Cmax and Tmax . [ Time Frame: Day 1-3 Single Dose and Day 1-21 Steady State ]In the study of single-dose, full Pharmacokinetics(PK) profiles of HMPL-504 will be obtained following administration of a single oral dose of HMPL-504 on Day 1 to Day 3. At multiple-dose, Pharmacokinetics(PK) sampling will include a pre-dose and at the 0.5,2,4,6,8 hour time points on days 1,15,21of dosing in the first 21-Day cycle of therapy, and pre-dose on days 2,8,16,and 22 of the first 21-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): NCT01985555
|Beijing, Beijing, China|
|Principal Investigator:||Lin Shen, MD.PHD||Investigator|