NCT02326025

A Study of Olaratumab and Doxorubicin in Participants With Advanced Soft Tissue Sarcoma

An Open-Label Study to Evaluate the Pharmacokinetics of Doxorubicin Following the Concomitant Intravenous Administration of Olaratumab (IMC-3G3) to Patients With Advanced Soft Tissue Sarcoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess how the body handles olaratumab when it is given with another drug called doxorubicin. The safety and tolerability of these drugs will be studied. Each participant will complete two 21-day cycles in a fixed order. Participants who complete Cycle 2 may continue to receive olaratumab + doxorubicin for an additional six 21-day cycles and then may receive olaratumab alone until discontinuation criteria are met. Screening is required within 21 days prior to first dose. Part B was added in October, 2015 to assess how the body handles a higher dose of olaratumab when given with doxorubicin. Participants may only enroll in one part.

Conditions

• Sarcoma, Soft Tissue

Interventions

Type	Name	Description
DRUG	Olaratumab	Administered IV
DRUG	Doxorubicin	Administered IV

Timeline

• Start date: 2015-01-22
• Primary completion: 2015-05-20
• Completion: 2018-11-02
• First posted: 2014-12-25
• Last updated: 2019-11-21
• Results posted: 2019-11-21

Locations

6 sites across 1 country: United States