NCT02076451

Open-label Study of DS-8273a to Assess Its Safety and Tolerability, and Assess Its Pharmacokinetic and Pharmacodynamic Properties in Subjects With Advanced Solid Tumors or Lymphomas

PHASE 1, OPEN-LABEL STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF DS-8273A IN SUBJECTS WITH ADVANCED SOLID TUMORS OR LYMPHOMAS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a Phase 1, open-label study of DS-8273a to assess its safety and tolerability, identify the Maximum Tolerated Dose and/or Maximum Administered Dose, and assess its properties in subjects with advanced solid tumors or lymphomas. Up to 5 US sites are planned for participation in Part 1 (Dose Escalation) and Part 2 (Dose Expansion) in subjects with solid tumors or lymphomas.

Conditions

• Advanced Solid Tumor
• Lymphoma

Interventions

Type	Name	Description
DRUG	DS-8273a	DS-8273a will be administered as an intravenous (IV) solution. Subjects will receive DS-8273a on Day 1 of a 21 day cycle (once every 3 weeks

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-03-03
• Last updated: 2019-02-12

Locations

1 site across 1 country: United States