drugset / Trial / NCT03699449
An uMbrella Study of BIomarker-driven Targeted Therapy In Patients With Platinum-resistant Recurrent OvariaN Cancer(AMBITION)
Phase 2
Unknown
104 enrolled
Yonsei University
AstraZeneca · collabKorean Gynecologic Oncology Group · collabSamsung Genomic Institute · collabSamsung Medical Center · collabSeoul National University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a pilot study of biomarker-driven targeted therapy in patients with platinum-resistant recurrent ovarian cancer. More specifically, this is a randomized, multi-center, open label, phase II study for Homologous Recombination Deficiency(HRD)+ patients and a biomarker-driven multiple-arm phase II study for Homologous Recombination Deficiency(HRD)- patients. This study will consist of a number of study modules (substudies), each evaluating the antitumor activity of targeted agents in patients whose tumors express specific phenotype relevant to the molecules under investigation.
Timeline
- Start
- 2018-11-26
- Primary completion
- 2022-09
- Completion
- 2022-09
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.
- Lee JY, Kim BG, Kim JW, Lee JB, Park E, Joung JG, Kim S, Choi CH, Kim HS; Korean Gynecologic Oncology Group (KGOG) investigators. Biomarker-guided targeted therapy in platinum-resistant ovarian cancer (AMBITION; KGOG 3045): a multicentre, open-label, five-arm, uncontrolled, umbrella trial. J Gynecol Oncol. 2022 Jul;33(4):e45. doi: 10.3802/jgo.2022.33.e45. Epub 2022 Mar 4.
- Lee JY, Yi JY, Kim HS, Lim J, Kim S, Nam BH, Kim HS, Kim JW, Choi CH, Kim BG; KGOG investigators. An umbrella study of biomarker-driven targeted therapy in patients with platinum-resistant recurrent ovarian cancer: a Korean Gynecologic Oncology Group study (KGOG 3045), AMBITION. Jpn J Clin Oncol. 2019 Aug 1;49(8):789-792. doi: 10.1093/jjco/hyz085.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cediranib | Small molecule | 30 mg | Oral |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Olaparib | Small molecule | 200 mg | Oral |
| Subject | Olaparib | Small molecule | 300 mg | Oral |
| Subject | Tremelimumab | Monoclonal antibody | 75 mg | Intravenous |
| Subject | Tremelimumab | Monoclonal antibody | 300 mg | Intravenous |
| Background | Doxorubicin | Other / unclassified | 40 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 60 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Background | Topotecan | Small molecule | 4 mg/m2 | — |
Indications
No indication recorded.