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)
Who can take part
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Women may be able to participate if they have:
- ovarian, fallopian tube or primary peritoneal cancer of clear-cell, endometrioid or high-grade serous type, or carcinosarcoma.
- had chemotherapy previously, but the cancer is resistant to platinum (carboplatin or cisplatin) chemotherapy (cancer has grown or come back within 6 months of completing the last round of chemotherapy).
This is not an exhaustive list. Women interested in participating in a clinical trial should speak to their own doctor about what other criteria might apply.
About the trial
This study is looking at using a new drug called TAK228 (new drug) in combination with paclitaxel (a chemotherapy drug) to see if it is a more effective way of treating ovarian cancer. If you were to take part in this trial you would be randomised to receive either paclitaxel on its own or paclitaxel and TAK228.
You would be monitored throughout the trial to see how your cancer is responding to treatment and to learn more about the side effects of adding TAK228 to paclitaxel, and how these compare to paclitaxel on its own.
The study will also look at DNA to try and find 'biomarkers'. In cancer, a biomarker is anything in the body that can be used to measure or predict the activity of the cancer or the effects of treatment. This will help our understanding of which people may benefit from receiving TAK228 and paclitaxel in future. Another purpose of this study is to see how differences in the genetic makeup of the cancer may influence the way women respond to or develop side effects from TAK228 when it's given in combination with paclitaxel. This will help scientists to understand in which women these drugs might be most effective and safe to use.
Drugs being used in this trial:
- TAK228 (new drug) – an oral medication that is thought to interfere with cell growth and may slow or stop cancer cells from dividing. Studies in the laboratory and in clinical trials in a small number of participants have shown that TAK228 works together with paclitaxel chemotherapy to produce a larger than expected anti-cancer effect in the laboratory and also in smaller clinical trials in participants with various forms of cancer.
- Paclitaxel – a standard chemotherapy drug used to treat ovarian cancer.