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)

An International Multi-centre Randomised Phase II Study to Assess the Efficacy of TAK228 in Combination With Intravenous Weekly Paclitaxel Compared With Weekly Paclitaxel Alone in Women With Advanced/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study is for women with ovarian cancer that has come back following treatment, and is resistant to platinum chemotherapy. Weekly paclitaxel chemotherapy is standard for these women, but there is a need to provide more effective treatments. TAK228 is an unlicensed oral drug that blocks the PI3K/AKT/mTOR pathway, which is important to the survival and spread of cancer cells. When TAK228 is combined with paclitaxel in the laboratory, the anti-cancer effect of both is increased. The DICE trial will show whether using TAK228 in combination with weekly paclitaxel is more effective at treating the patient population than weekly paclitaxel alone. DICE will also look for 'biomarkers' that measure the activity of the cancer and the effects of treatment. This may help us understand which women might benefit from receiving TAK228 and weekly paclitaxel in future. Randomisation will be to one of 2 groups (63 women in each). Treatment is divided into 4 week 'cycles': Group 1: weekly paclitaxel for 3 weeks followed by 1 week rest each cycle Group 2: weekly paclitaxel (see Group 1) plus TAK228 for 12 days each cycle Women will stop treatment when the cancer grows significantly, there are unacceptable side effects, or the investigator and/or patient decides to stop. Women will be followed up until 6 months after the last patient receiving study treatment stops that treatment.

Conditions

• Ovarian Cancer
• Ovarian Neoplasms
• Ovarian Carcinosarcoma
• Ovarian Serous Adenocarcinoma
• Ovarian Endometrioid Adenocarcinoma
• Ovarian Clear Cell Adenocarcinoma
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Primary Peritoneal Carcinoma
• Primary Peritoneal Serous Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Paclitaxel	Please refer to arm/group description
DRUG	TAK228	Please refer to arm/group description

Timeline

• Start date: 2018-09-21
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2018-08-27
• Last updated: 2024-09-20

Locations

15 sites across 2 countries: Germany, United Kingdom