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Completed Phase 1 Interventional Results available

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

ClinicalTrials.gov ID: NCT02326025

Public ClinicalTrials.gov record NCT02326025. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 8:06 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02326025
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Eli Lilly and Company
Industry
Enrollment
49 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 22, 2015 (Actual)
Primary completion
May 20, 2015 (Actual)
Completion
Nov 2, 2018 (Actual)
Last update posted
Nov 21, 2019

2015 – 2018

United States locations

U.S. sites
6
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
UCLA Medical Center Los Angeles California 90095 —
University of Colorado Cancer Center Aurora Colorado 80045 —
Northwestern University Chicago Illinois 60611 —
IU Simon Cancer Center Indianapolis Indiana 46202 —
Washington University Medical Center St Louis Missouri 63110 —
Seattle Cancer Care Alliance Seattle Washington 98109 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02326025, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 21, 2019 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02326025 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →