A Study of Soft Tissue Sarcoma with Olaratumab, Gemcitabine and Docetaxel

A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma - ANNOUNCE 2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001316-34-HU

Enrollment

215

Registered

2015-11-12

Start date

2016-01-26

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

soft tissue sarcoma MedDRA version: 15.1 Level: HLGT Classification code 10041299 Term: Soft tissue sarcomas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Code: LY3012207 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Olaratumab CAS Number: 1024603-93-7 Current Sponsor code: LY3012207 Other descriptive name: OLAR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients at least 16 years of age, ECOG PS 0 to 1, gemcitabine, docetaxel, and olaratumab naïve, with histologically confirmed, locally advanced, unresectable or metastatic STS, and not amenable to curative treatment with surgery or radiotherapy Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 95 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

Exclusion criteria: Patients with gastrointestinal stromal tumor or Kaposi’s sarcoma will be excluded. Patients previously enrolled in Study I5B-MC-JGDJ or any other blinded study with olaratumab are not eligible to participate in this trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: Overall Survival (OS);Secondary Objective: Progression-Free Survival (PFS) ;Primary end point(s): Overall Survival;Timepoint(s) of evaluation of this end point: This study will be considered complete following final analysis of the OS endpoint (at least 108 OS events) has been performed and evaluated, as determined by Lilly.	—

Secondary

Measure	Time frame
Secondary end point(s): Progression Free Survival (OS);Timepoint(s) of evaluation of this end point: Conclusion of phase II trial	—

Countries

Australia, France, Germany, Hungary, Israel, Italy, Poland, Spain, United Kingdom, United States

Contacts

Public ContactClinical Trial Registry Office

Eli Lilly

EU_Lilly_Clinical_Trials@lilly.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026