NCT02048488

A Phase I/IIa Open-Label, Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and Lymphomas

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Tesaro, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TSR-011 is a potent small molecule inhibitor of tyrosine kinases involved in cancer, including: 1. Anaplastic lymphoma kinase (ALK) 2. The tropomyosin-related kinases TRKA, TRKB, and TRKC This is a sequential, open-label, non-randomized study with dose escalation in Phase 1, followed by expansion at a recommended phase 2 dose.

Conditions

• Solid Tumors
• Lymphomas

Interventions

Type	Name	Description
DRUG	TSR-011	Number of cycles until progression or unacceptable toxicity develops.

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-09-01
• Completion: 2018-06-01
• First posted: 2014-01-29
• Last updated: 2019-03-26

Locations

15 sites across 5 countries: United States, Poland, Spain, Taiwan, United Kingdom