Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sulfatinib · 4 trials · 3 indications
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);elimination half-life
the safety of Sulfatinib
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
The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.
| Arm | Type | Description |
|---|---|---|
| Sulfatinib ,after general diet | EXPERIMENTAL | First cycle, single oral Sulfatinib after general diet intake; Second cycle, Sulfatinib before general diet intake. |
| Sulfatinib, before general diet | EXPERIMENTAL | First cycle, single oral Sulfatinib before general diet intake;Second cycle,single oral Sulfatinib after general diet intake |
| Sulfatinib | EXPERIMENTAL | Sulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle. |
| Sulfatinib capsule | EXPERIMENTAL | cohort 1: Sulfatinib single oral dosing;after 7days,Sulfatinib continuous oral dosing ( once a day) 28days as a cycle. |
| [14C]Sulfatinib | OTHER | This is a single center and single dose in 6 volunteers. Subject would take a suspension containing 300 mg of Sulfatinib (containing about 100 μCi of radioactivity) within 1 hour after standard breakfast. |
| Name | Type | Description |
|---|---|---|
| Sulfatinib | DRUG | 250mg Sulfatinib ,single dose,oral |
| [14C]Sulfatinib | DRUG | 300 mg Sulfatinib with 100 µCi \[14C\] |
Inclusion Criteria: * Males , between 18 and 55 years of age, inclusive. * Body mass index (BMI) within the range of 20 to 30 kg/m2, inclusive. * In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs. * Adequate hep...
Sulfatinib is an investigational small molecule being studied for the treatment of advanced solid tumors, including neuroendocrine tumors. Clinical trials have evaluated it in patients with tumor conditions and neuroendocrine tumors, as well as in healthy subjects for pharmacokinetic studies. It is not yet approved and remains in clinical development.
Sulfatinib is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the stock exchange under the ticker HCM. The company has sponsored clinical trials of Sulfatinib in China, including studies in patients with advanced solid tumors and neuroendocrine tumors.
Sulfatinib is in Phase 1 clinical development. Completed trials include a Phase I study in patients with advanced solid tumors, a Phase Ib/II study in advanced neuroendocrine tumors, and early Phase 1 studies in healthy subjects. All trials are completed, and the drug remains investigational.
Sulfatinib has been studied in several completed clinical trials, including NCT02133157 (Phase I in advanced solid tumors), NCT02267967 (Phase Ib/II in neuroendocrine tumors), NCT02320409 (food effect study in healthy subjects), and NCT03627520 (mass balance study). These trials were conducted in China.
Yes, Sulfatinib is also known as HMPL-012. Clinical trial titles reference both names, such as 'Phase I Study of Sulfatinib(HMPL-012) in Patients With Advanced Solid Tumors.' This alternative name may appear in scientific literature and trial registries.