A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma
Summary
The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with advanced or metastatic soft tissue sarcoma.
Timeline
- Start
- 2015-09-14
- Primary completion
- 2018-12-05
- Completion
- 2024-06-27
Outcome
Missed primary endpoint
registry analysis (superiority test); Doxorubicin + Olaratumab vs Doxorubicin + Placebo; p = 0.6945; Hazard Ratio (HR) 1.047 (95% CI 0.841 to 1.303); Log Rank NCT02451943 ↗
registry analysis (superiority test); Doxorubicin + Olaratumab vs Doxorubicin + Placebo; p = 0.7618; Hazard Ratio (HR) 0.951 (95% CI 0.690 to 1.312); Log Rank NCT02451943 ↗
paper No statistically significant difference in overall survival was observed between the doxorubicin plus olaratumab group vs the doxorubicin plus placebo group in either population PMID 32259228 ↗
release “ANNOUNCE trial, which studied olaratumab in combination with doxorubicin in soft tissue sarcoma. Unfortunately, this study did not confirm a survival benefit” lilly.com ↗
Publications
- Jones RL, Wagner AJ, Kawai A, Tamura K, Shahir A, Van Tine BA, Martin-Broto J, Peterson PM, Wright J, Tap WD. Prospective Evaluation of Doxorubicin Cardiotoxicity in Patients with Advanced Soft-tissue Sarcoma Treated in the ANNOUNCE Phase III Randomized Trial. Clin Cancer Res. 2021 Jul 15;27(14):3861-3866. doi: 10.1158/1078-0432.CCR-20-4592. Epub 2021 Feb 25.
- Tap WD, Wagner AJ, Schoffski P, Martin-Broto J, Krarup-Hansen A, Ganjoo KN, Yen CC, Abdul Razak AR, Spira A, Kawai A, Le Cesne A, Van Tine BA, Naito Y, Park SH, Fedenko A, Papai Z, Soldatenkova V, Shahir A, Mo G, Wright J, Jones RL; ANNOUNCE Investigators. Effect of Doxorubicin Plus Olaratumab vs Doxorubicin Plus Placebo on Survival in Patients With Advanced Soft Tissue Sarcomas: The ANNOUNCE Randomized Clinical Trial. JAMA. 2020 Apr 7;323(13):1266-1276. doi: 10.1001/jama.2020.1707.
- Tobias A, O'brien MP, Agulnik M. Olaratumab for advanced soft tissue sarcoma. Expert Rev Clin Pharmacol. 2017 Jul;10(7):699-705. doi: 10.1080/17512433.2017.1324295. Epub 2017 May 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Olaratumab | Monoclonal antibody | 15 mg/kg | Intravenous |