Solid Tumor, Adult Clinical Trial
Official title:
A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of Telatinib, a Selective Inhibitor of the Vascular Endothelial Growth Factor (VEGF) Receptor, in Adult Chinese Patients With Advanced Solid Tumors
The purpose of this China Phase I bridging study is to to evaluate the safety, tolerability and pharmacokinetic profile of telatinib in China patients with advanced solid tumor
This is an open-label, nonrandomized, phase I, escalating dose study to evaluate the safety,
tolerability and pharmacokinetic profile of telatinib. .
This study is comprised of two stages. The 1st stage follows the traditional 3+3
dose-escalation design. Telatinib mesylate tablets will be administrated orally to patient
twice daily at a starting dose of 600 mg bid. Patients will be successively enrolled into
three cohorts from low-dose to high-dose (600 mg bid, 900 mg bid, and 1200 mg bid). For each
cohort, patient will be first enrolled for single-dose PK and safety observation. After
one-day interval, patient will then be resumed for a 21-day continuous treatment to assess
safety, tolerability and PK profile with multiple dosing.
The dose-limiting toxicity (DLT) observation period will be 23 days, starting from the first
day of single dosing till the end of the 21-day continuous treatment.
If first 3 subjects at a dose level complete a cohort without experiencing any DLT, subjects
for the next higher cohort will be recruited. If 1 of the first 3 subjects experiences DLT,
then up to three additional subjects (total up to six subjects) will enrolled at that dose
level. If more than 2 patients at a dose level experienced DLT, dose escalation will be
halted. And the dose level will be declared the toxic dose. The MTD is defined as the
previous (lower dose) dose level.
If MTD is not observed even at 1200 mg bid, dose-escalation will not be continued.
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