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The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of volitinib administered to patients with locally advanced or metastatic solid tumors and determine MTD (Maximum Tolerated Dose) or RPTD(recommended Phase 2 dose).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volitinib(HMPL-504) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volitinib(HMPL-504) | Drug | Volitinib(HMPL-504) is a tablet in the form of 25 mg ,100mg and 200 mg,oral,once daily or 2 times a day. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | up to 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Assessments for area under curve (AUC), Cmax and Tmax . | 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 |
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Inclusion Criteria:
Metastatic or locally advanced gastric cancer patients with cMet positive b)Metastatic or locally advanced EGFR wild type NSCLC patients and with cMet positive.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lin Shen, MD.PHD | Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BeijingCancer Hospital | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000593259 | 1-(1-(imidazo(1,2-a)pyridin-6-yl)ethyl)-6-(1-methyl-1H-pyrazol-4-yl)-1H-(1,2,3)triazolo(4,5-b)pyrazine |
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| Day 1-3 Single Dose and Day 1-21 Steady State |