Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Volitinib · 5 trials · 6 indications
the grade of AE event according to CTC AE 4.0
* Incidence and nature of DLTs * Incidence and severity of AE/SAEs
The following PK parameters will be derived from the plasma concentration-time profile of Volitinib following administration:Area Under Curve (AUC), both from time zero to time with last observation and from time zero to infinity;;Maximum plasma concentration (Cmax);Time to reach the Cmax (Tmax);Apparent oral Clearance (CL/F);Apparent oral Volume of distribution (Vz/F);Other parameters, such as elimination half-life
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).
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).
| Arm | Type | Description |
|---|---|---|
| Volitinib (AZD6094) 600mg + gefitinib 250 mg | EXPERIMENTAL | Cohort 1: Volitinib（AZD6094） 600 mg od + gefitinib 250 mg od |
| Volitinib (AZD6094) 800mg + gefitinib 250 mg | EXPERIMENTAL | Cohort 2: Volitinib（AZD6094） 800 mg od + gefitinib 250 mg od |
| Volitinib+docetaxel | EXPERIMENTAL | Dose escalation stage: oral administration, Volitinib 600mg/800 QD + docetaxel 75mg/m2. If the dose of docetaxel 75mg/m2 is not tolerable, docetaxel dose will be reduced to 60mg/m2 while keep volitinib at 600mg QD as the initial dose. Volitinib dose escalation will be re-started and end at the dose of 800mg QD. Dose expansion Stage:Volitinib with docetaxel. Use the prefer dose from escalation stage |
| Volitinib ,after high fat meal intake | EXPERIMENTAL | A:single oral Volitinib after high fat meal intake |
| Volitinib,after general diet | EXPERIMENTAL | B:single oral Volitinib, after general diet |
| 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. |
| Name | Type | Description |
|---|---|---|
| Volitinib | DRUG | 600mg or 800mg QD: Patients may continue to receive the treatment as long as they are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria. |
| gefitinib | DRUG | 250mg QD: Patients may continue to receive the treatment as long as they are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria. |
| Docetaxel | DRUG | intravenous injection |
| 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. |
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures. If a patient declines to participate in any voluntary exploratory research and/or genetic component of the study there will be no penalty or loss of benefit to the patient and he or she will not be excluded...
Volitinib is an investigational small molecule being studied for gastric cancer, non-small cell lung cancer, and advanced solid tumors. It has also been evaluated in a food effect study in healthy subjects. Volitinib is in Phase 1 clinical development and is not yet approved by the FDA.
Volitinib is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the stock exchange under the ticker HCM. The company is conducting clinical trials of Volitinib in China.
Volitinib is in Phase 1 clinical development. All four clinical trials listed for Volitinib are Phase 1 studies and have been completed. Volitinib is an investigational drug and has not received FDA approval.
Volitinib has been studied in four completed Phase 1 trials: NCT01985555 in advanced solid tumors, NCT02017236 in healthy subjects for food effect, NCT02252913 in gastric cancer with docetaxel, and NCT02374645 in EGFR-positive non-small cell lung cancer with gefitinib.
Yes, Volitinib is also known as HMPL-504. The Phase 1 study NCT01985555 is titled 'Phase I Study of the Volitinib (HMPL-504) in Patients With Advanced Solid Tumors,' confirming that both names refer to the same drug.