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).
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
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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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