Phase I Study of the Volitinib (HMPL-504) in Patients With Advanced Solid Tumors
- Conditions
- Histologically or cytologically documented, incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior systemic therapyCancer - Any cancer
- Registration Number
- ACTRN12613000133730
- Lead Sponsor
- Hutchison Medipharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
Signed Informed Consent Form ,locally advanced, or metastatic solid malignancy ;Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1;Male or female patients of child-producing potential must agree to take contraception measures to avoidance of pregnancy during the study and for 90 days after the last day of treatment;
Patients with gastric cancer , NSCLC, colorectal cancer, breast cancer and hepatocellular carcinoma(HCC) are preferred to be enrolled into the study.
Inadequate hematologic and organ function, defined by the following ;
Clinical significant active infection;
Adverse events from prior anti-cancer therapy that have not resolved to Grade = 1, except for alopecia;
Pregnant or lactating women;
History of myocardial infarction ;
Active or untreated brain metastasis;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The safety and tolerability of single and multiple doses of HMPL-504 administered to patients,The safety and tolerability variables to be evaluated in this study are adverse events, physical examinations, vital signs ,clinical laboratory evaluations including serum chemistry, hematology , and urinalysis , and electrocardiograms (ECGs) in triplicate,Incidence and nature of DLTs(Dose-Limiting Toxicity),To determine the MTD (Maximum Tolerated Dose).[up to 20 months]
- Secondary Outcome Measures
Name Time Method Pharmacokinetic Assessments for area under curve (AUC), Cmax and Tmax [Day 1-3 Single Dose and Day 1-21 Steady State]