A study of Doxorubicin plus Olaratumab versus Doxorubicin plus Placebo in Patients with Soft Tissue Sarcoma

Phase 1

• Conditions: Advanced or Metastatic Soft Tissue Sarcoma; MedDRA version: 18.1Level: HLTClassification code 10041298Term: Soft tissue sarcomas histology unspecifiedSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000134-30-FR
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-06
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

18 years or older at study entry
Histologically confirmed diagnosis of locally advanced unresectable or metastatic STS not amenable to curative treatment with surgery or radiotherapy. Grade 1 liposarcoma are eligible if there is histological or radiographic evidence of evolution to more aggressive disease. (excludes GIST & Kaposi)
Measurable or nonmeasurable but evaluable disease by RECIST 1.1
ECOG 0-1
May have had any number of prior systemic therapies for advanced/metastatic disease, however may not have received any previous treatment with anthracyclines. All previous therapies must have been completed = 4 weeks (28 days) prior to randomization.
Consent to provide archived FFPE tumor tissue or be subject to a pre-treatment re-biopsy of primary or metastatic tumor tissue future central pathology review and translational research (if archived tissue is unavailable)
LVEF ›= 50%
Life expectancy, in opinion of the investigator, is at least 3 months
Females of child-bearing potential must have a negative serum pregnancy test within 7 days prior to randomization.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

Diagnosed with GIST or Kaposi sarcoma
Active CNS or brain metastasis at randomization
The patient has received prior treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones; the patient has received prior olaratumab treatment.
Prior radiotherapy of the mediastinal/pericardial area or whole pelvis radiation
Electively planned or required major surgery during the study
Uncontrolled intercurrent illness including, but not limited to, an ongoing/active infection requiring parenteral antibiotics, symptomatic congestive heart failure (CHF), left ventricular dysfunction (LVEF<50%), severe myocardial insufficiency, cardiac arrhythmia, cardiomyopathy, or a psychiatric illness/social situation that would limit compliance with study requirements
Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction
Resting heart rate of ›= 100 bpm
QTc interval ›= 450 msec and ›= 470 msec for males and females, respectively, on screening ECG
Current hematologic malignancies
Pregnant or breastfeeding
Active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified