NCT03175497

Telatinib Safety and Pharmacokinetics Study in China Patients With Advanced Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Taizhou EOC Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	Telatinib Mesylate	Telatinib mesylate tablets will be administrated twice a day orally

Timeline

• Start date: 2017-07-25
• Primary completion: 2018-08-15
• Completion: 2018-08-15
• First posted: 2017-06-05
• Last updated: 2019-05-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study