NCT01931943

A Phase Ib Study of Selatinib Ditosilate Tablets in Patients With Advanced Breast Cancer

A Phase Ib Study to Evaluate the Tolerability and Pharmacokinetics of Selatinib Ditosilate Tablets in Patients With Advanced Breast Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Brief Description: This study is designed to evaluate the safety and tolerability of oral Selatinib Ditosilate Tablets, and explore the maximum tolerated dose (MTD) and dose-limiting toxicity in patients with advanced breast cancer.

Detailed description

1. To evaluate the safety and tolerability of oral Selatinib Ditosilate Tablets, and explore the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). 2. To determine the pharmacokinetic profile of single and multi oral Selatinib Ditosilate Tablets . 3. To determine preliminary dose and regimen for phase II study of oral Selatinib Ditosilate Tablets. 4. To assess preliminary antitumor activity .

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	selatinib ditosilate tablets

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-12-01
• First posted: 2013-08-30
• Last updated: 2013-08-30

Locations

1 site across 1 country: China