DICE version 1.0

• Research type

  Research Study

• Full title

  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)

• IRAS ID

  196718

• Contact name

  Jonathan Krell

• Contact email

  j.krell@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Eudract number

  2016-000065-23

• Duration of Study in the UK

  3 years, 6 months, 0 days

• Research summary

  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.

  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).

  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 stops study treatment, or up to 18 months after the last patient is randomised, whichever is sooner.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  18/LO/0512

• Date of REC Opinion

  5 Jun 2018

• REC opinion

  Further Information Favourable Opinion