ATARI

• Research type

  Research Study

• Full title

  ATr inhibitor in combination with olaparib in gynaecological cancers with ARId1A loss or no loss

• IRAS ID

  254912

• Contact name

  Susana Banerjee

• Contact email

  susana.banerjee@rmh.nhs.uk

• Sponsor organisation

  The Institute of Cancer Research

• Eudract number

  2018-003779-36

• Duration of Study in the UK

  3 years, 6 months, 1 days

• Research summary

  Gynaecological cancers include cancers of the ovary, uterus (‘endometrial’) and cervix. Together, they affect almost 20,000 women in the UK every year and over 7,000 women die of these cancers every year. Most patients with relapsed gynaecological cancers may initially respond to chemotherapy but eventually the disease becomes resistant to treatment. For women with rarer types of advanced/recurrent gynaecological cancer (including ‘clear cell’, ‘carcinosarcoma’ and cervical cancer) the chance of tumour shrinkage with current treatments is poor and there are no specific targeted treatment options.

  ATARI is a clinical trial that has been designed based on the latest lab research which shows that cancers with a specific abnormality in a gene (mutation) called ARID1A are more likely to be killed by a new class of anti-cancer therapy called ATR inhibitors. This molecular abnormality (‘ARID1A loss’) is present more commonly in some rare subtypes of gynaecological cancer. Laboratory work has also shown that some cancers without an ARID1A mutation (‘ARID1A no loss’) can be killed more by ATR inhibitors in combination with PARP inhibitors.

  ATARI tests the ATR inhibitor drug called AZD6738 and a PARP inhibitor drug called olaparib. The trial design assesses the response (tumour shrinkage) in groups of patients selected based on their cancer cell subtype and the presence of an abnormality in ARID1A.

  The treatment groups are:
  1A. Women with clear cell subtype with (ovarian/uterus) ARID1A loss treated with AZD6738
  1B. Women with clear cell subtype with (ovarian/uterus) ARID1A loss treated with AZD6738 + olaparib
  2. Women with clear cell subtype (ovarian/uterus) with no ARID1A loss treated with AZD6738 and olaparib
  3. Women with other rare gynaecological cancers (carcinosarcoma, cervical, endometrioid type) irrespective of ARID1A loss treated with AZD6738 and olaparib

  It is expected that ATARI will run internationally with patients recruited in the UK, France and Canada.

• REC name

  London - South East Research Ethics Committee

• REC reference

  19/LO/1082

• Date of REC Opinion

  23 Sep 2019

• REC opinion

  Further Information Favourable Opinion