ANNOUNCE - Olaratumab and Doxorubicin in Soft Tissue Sarcoma (JDGJ)
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Doxorubicin plus Olaratumab versus Doxorubicin plus Placebo in Patients with Advanced or Metastatic Soft Tissue Sarcoma
IRAS ID
186964
Contact name
Robin Jones
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2015-000134-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 3 days
Research summary
Study I5B-MC-JGDJ is a global, multicentre, randomised, double-blind, placebo-controlled Phase 3 trial comparing the efficacy and safety of Doxorubicin + Olaratumab with Doxorubicin + Placebo in patients with advanced or metastatic soft tissue sarcoma (STS). The study will run for about 45 months and is planning to recruit around 460 patients.
Eligible patients will be randomised 1:1 into the 2 treatment options and defined by all combinations of the following:
• Number of prior systemic therapies for advanced/metastatic disease (0 versus ≥1)
• Histological tumour type (leiomyosarcoma versus liposarcoma versus pleomorphic versus other STS types)
• Eastern Cooperative Oncology Group performance status (0 versus 1)
• Region (North America versus Europe versus Rest of World).Olaratumab/Placebo will be administered to patients as an IV infusion. Patients will receive a loading dose of Olaratumab (20 mg/kg) on Days 1 and 8 in Cycle 1, followed by a dose of 15 mg/kg on Days 1 and 8 in subsequent 21-day cycles. Commercial formulations of Doxorubicin (75 mg/m2) will be administered on Day 1 of each 21-day cycle, for 8 cycles. Commercially available Dexrazoxane may be administered starting at Cycle 1 at a 10:1 ratio (Dexrazoxane:Doxorubicin) at the investigator’s discretion, prior to the Doxorubicin infusion for the prevention of cardiotoxicity and its use is recommended in patients receiving 5 or more cycles of Doxorubicin.
Patients will receive combination treatment (Olaratumab/Placebo + Doxorubicin) for 8 cycles. Patients who discontinue Doxorubicin due to unacceptable toxicity prior to the completion of the planned 8 cycles, may continue receiving only Olaratumab/placebo. Patients who complete 8 cycles of combination treatment will continue to receive Olaratumab/placebo monotherapy at the same dose and schedule. Treatment will continue until there is documentation of disease progression, death, intolerable toxicity, or other discontinuation criteria are met.
No crossover will be permitted.REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0676
Date of REC Opinion
1 Dec 2015
REC opinion
Favourable Opinion