NCT01806376

A Phase I Study of Subutinib Maleate Capsules on Toleration and Pharmacokinetics

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

1. purpose: to explore the maximum tolerated dose, dose-limiting toxicity of oral Subutinib Maleate capsules and rational dosage regimen for phase Ⅱ study 2. Experimental Design： A phase Ⅰ study of single-center 3. Test drug: Subutinib Maleate capsules 4. Sample size≥20

Detailed description

The primary objective of this study is to explore the maximum tolerated dose, dose-limiting toxicity of oral Subutinib Maleate capsules and rational dosage regimen for phase Ⅱ study, to investigate the pharmacokinetics of single and multiple oral doses of Subutinib Maleate capsules.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Subutinib Maleate capsules	Dose escalation will be dependent on any dose limiting toxicities

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-03-07
• Last updated: 2013-03-08

Locations

1 site across 1 country: China