NCT03648489: DICE

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)

Completed Phase 2 Last updated 20 September 2024

What this trial tests

Phase 2 trial testing Paclitaxel in Ovarian Cancer in 134 participants. Completed in 30 November 2023.

Timeline

21 September 2018

Primary endpoint
30 November 2023

30 November 2023

Quick facts

Lead sponsor	Imperial College London
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	134
Start date	21 September 2018
Primary completion	30 November 2023
Estimated completion	30 November 2023
Sites	15 locations across United Kingdom, Germany

Drugs / interventions tested

• Paclitaxel — full drug profile →
• TAK228 — full drug profile →

Conditions studied

• Ovarian Cancer — all drugs for Ovarian Cancer →
• Ovarian Neoplasms — all drugs for Ovarian Neoplasms →
• Ovarian Carcinosarcoma — all drugs for Ovarian Carcinosarcoma →
• Ovarian Serous Adenocarcinoma — all drugs for Ovarian Serous Adenocarcinoma →

Sponsor

Imperial College London

Who can join

18 and older, female only, with Ovarian Cancer or Ovarian Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Drug resistance in ovarian cancer: from mechanism to clinical trial.
   Wang L, Wang X, Zhu X, Zhong L, et al · · 2024 · cited 139× · PMID 38539161 · DOI 10.1186/s12943-024-01967-3
2. PI3K-AKT-mTOR and NFκB Pathways in Ovarian Cancer: Implications for Targeted Therapeutics.
   Ghoneum A, Said N. · · 2019 · cited 118× · PMID 31284467 · DOI 10.3390/cancers11070949
3. Recent advances and limitations of mTOR inhibitors in the treatment of cancer.
   Ali ES, Mitra K, Akter S, Ramproshad S, et al · · 2022 · cited 115× · PMID 36109789 · DOI 10.1186/s12935-022-02706-8
4. Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
   Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6
5. Efficacy and Safety of Weekly Paclitaxel Plus Vistusertib vs Paclitaxel Alone in Patients With Platinum-Resistant Ovarian High-Grade Serous Carcinoma: The OCTOPUS Multicenter, Phase 2, Randomized Clinical Trial.
   Banerjee S, Giannone G, Clamp AR, Ennis DP, et al · · 2023 · cited 26× · PMID 36928279 · DOI 10.1001/jamaoncol.2022.7966
6. Molecular Targeting of the Phosphoinositide-3-Protein Kinase (PI3K) Pathway across Various Cancers.
   Shan KS, Bonano-Rios A, Theik NWY, Hussein A, et al · · 2024 · cited 19× · PMID 38396649 · DOI 10.3390/ijms25041973
7. Frontiers of Ovarian Carcinosarcoma.
   Ismail A, Choi S, Boussios S. · · 2023 · cited 18× · PMID 37938504 · DOI 10.1007/s11864-023-01138-4
8. Review the progression of ovarian clear cell carcinoma from the perspective of genomics and epigenomics.
   Tong A, Di X, Zhao X, Liang X. · · 2023 · cited 11× · PMID 36873929 · DOI 10.3389/fgene.2023.952379