AZD1775 in patients with Ovarian, Fallopian Tube, or Peritoneal Cancer

• Research type

  Research Study

• Full title

  A Multicentre Randomised Phase II Study of AZD1775 plus Chemotherapy Versus Chemotherapy Alone in Patients with Platinum-Resistant TP53-Mutated Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

• IRAS ID

  168445

• Sponsor organisation

  AstraZeneca UK Ltd

• Eudract number

  2015-000886-30

• Clinicaltrials.gov Identifier

  NCT02272790

• Duration of Study in the UK

  2 years, 9 months, 16 days

• Research summary

  This is a randomised phase II study of AZD1775 plus chemotherapy versus chemotherapy alone in patients with platinum-resistant TP53-Mutated epithelial ovarian, fallopian tube, or primary peritoneal cancer. This study will be conducted in two parts:
  Part 1 Randomised Lead-In Safety and Efficacy Selection. Patients will be randomised 1:1:1 to AZD1775 plus Paclitaxel, Gemcitabine, or Carboplatin. In this study, one chemotherapy drug will be combined with AZD1775 to treat your type of cancer. Three different chemotherapy and AZD1775 schedules will be tested.
  Approximately 69 patients will be randomised in Part 1 to one of three treatments (23 patients in each treatment arm).
  The three treatment arms in Part 1 of this study are:
  Arm A AZD1775 plus Gemcitabine chemotherapy
  Arm B AZD1775 plus weekly Paclitaxel chemotherapy
  Arm C AZD1775 plus Carboplatin chemotherapy
  The selected “Best Regimen” will be used in Part 2 for comparison with chemotherapy alone.
  Part 2 Randomised Comparison of AZD1775 plus Chemotherapy versus Chemotherapy Alone. Approximately 108 total patients will be enrolled at 30 global investigational sites.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  15/LO/0958

• Date of REC Opinion

  29 Jul 2015

• REC opinion

  Further Information Favourable Opinion