NCT02192567

Open Label Study of DS-5573a

Phase 1, Open Label Study to Assess the Safety and Pharmacokinetics of DS-5573a in Japanese Patients With Advanced Solid Malignant Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, sequential dose escalation and expansion study to evaluate the safety, and pharmacokinetics of DS-5573a in Japanese patients with advanced solid malignant tumors.

Conditions

• Advanced Solid Malignant Tumors

Interventions

Type	Name	Description
DRUG	DS-5573a	Step 1 of this study will use a starting intravenous (IV) dose of 0.1 mg/kg. Eight dose levels are planned, level 1: 0.1 mg/kg, level 1.5: 0.1 mg/kg, 0.3 mg/kg, level 2: 0.3 mg/kg, level 3: 1 mg/kg, level 4: 3 mg/kg, level 5: 10 mg/kg, level 6: 20 mg/kg, level 7: 30 mg/kg. Step 2: 30 subjects will use the dose determined in Step 1.

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2014-07-17
• Last updated: 2017-03-03

Locations

1 site across 1 country: Japan