drugset / Trial / NCT00913835
A Study of Liposomal Doxorubicin With or Without Olaratumab (IMC-3G3) in Platinum-Refractory or Resistant Advanced Ovarian Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine if participants with platinum-refractory or platinum-resistant advanced ovarian cancer have a better outcome when treated with Olaratumab (IMC-3G3) in combination with Liposomal Doxorubicin than when treated with Liposomal Doxorubicin alone.
Timeline
- Start
- 2009-06
- Primary completion
- 2011-10
- Completion
- 2014-02
Outcome
Missed primary endpoint
registry p = 0.8049; Hazard Ratio (HR) 1.054 (90% CI 0.751 to 1.478); Log Rank NCT00913835 ↗
paper The addition of olaratumab to liposomal doxorubicin did not result in significant prolongation of PFS or OS PMID 30591028 ↗
Publications
- Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
- McGuire WP, Penson RT, Gore M, Herraez AC, Peterson P, Shahir A, Ilaria R Jr. Randomized phase II study of the PDGFRalpha antibody olaratumab plus liposomal doxorubicin versus liposomal doxorubicin alone in patients with platinum-refractory or platinum-resistant advanced ovarian cancer. BMC Cancer. 2018 Dec 27;18(1):1292. doi: 10.1186/s12885-018-5198-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 40 mg/m2 | Intravenous |
| Subject | Olaratumab | Monoclonal antibody | 20 mg/kg | Intravenous |