drugset / Trial / NCT03648489
Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma)
Phase 2
Completed
134 enrolled
Imperial College London
North Eastern German Society of Gynaecological Oncology · collabTakeda Pharmaceuticals International, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
DICE is a randomised study recruiting 126 women over 3 years from hospitals in the UK and Germany. Eligible patients will have tissue based diagnosis of advanced/recurrent ovarian cancer (clear cell, endometrioid or high grade serous or carcinosarcoma), have had chemotherapy before, and be platinum-resistant (the cancer has returned/grown significantly during or within 6 months of platinum-containing chemotherapy).
Timeline
- Start
- 2018-09-21
- Primary completion
- 2023-11-30
- Completion
- 2023-11-30
Publications
- Fiorentino F, Krell J, de la Rosa CN, Webber L. DICE: Dual mTorc Inhibition in advanCed/recurrent Epithelial ovarian cancer resistant to standard treatment-a study protocol for a randomised trial investigating a novel therapy called TAK228. Trials. 2022 Apr 5;23(1):261. doi: 10.1186/s13063-022-06201-3.
- de la Rosa CN, Krell J, Day E, Clarke A, Reddi M, Webber L, Fiorentino F. Statistical analysis plan for the Dual mTorc Inhibition in advanCed/recurrent Epithelial ovarian, fallopian tube or primary peritoneal cancer (of clear cell, endometrioid and high-grade serous type, and carcinosarcoma) trial (DICE). Trials. 2022 Jan 5;23(1):13. doi: 10.1186/s13063-021-05669-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sapanisertib | Small molecule | 4 mg | Oral |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |