drugset / Trial / NCT01493505
TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.
Timeline
- Start
- 2012-01
- Primary completion
- 2016-03
- Completion
- 2016-12
Publications
- Background Fujiwara K, Monk BJ, Lhomme C, Coleman RL, Brize A, Oaknin A, Ray-Coquard I, Fabbro M, Provencher D, Bamias A, Vergote I, DeCensi A, Zhang K, Vogl FD, Bach BA, Raspagliesi F. Health-related quality of life in women with recurrent ovarian cancer receiving paclitaxel plus trebananib or placebo (TRINOVA-1). Ann Oncol. 2016 Jun;27(6):1006-1013. doi: 10.1093/annonc/mdw147. Epub 2016 Mar 30.
- 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.
- Vergote I, Scambia G, O'Malley DM, Van Calster B, Park SY, Del Campo JM, Meier W, Bamias A, Colombo N, Wenham RM, Covens A, Marth C, Raza Mirza M, Kroep JR, Ma H, Pickett CA, Monk BJ; TRINOVA-3/ENGOT-ov2/GOG-3001 investigators. Trebananib or placebo plus carboplatin and paclitaxel as first-line treatment for advanced ovarian cancer (TRINOVA-3/ENGOT-ov2/GOG-3001): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2019 Jun;20(6):862-876. doi: 10.1016/S1470-2045(19)30178-0. Epub 2019 May 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Trebananib | Peptide | 15 mg/kg | Intravenous |
| Comparator | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Comparator | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Comparator | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |