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ATARI: A trial looking at ceralasertib for ovarian and endometrial clear cell cancers 

Enrolment of participants on hold

What is the study about?

ATARI investigates whether a new type of drug could help treat people with certain types of gynaecological cancers that have come back after treatment.

Laboratory research has found that cancer cells with an abnormality (mutation) in a gene called ARID1A can be killed by a new type of drug called an ATR inhibitor. ARID1A abnormalities are more likely to be present in certain rare types of gynaecological cancers and particularly clear cell cancers of the ovaries and womb (endometrial).

Laboratory research has also shown ATR-inhibitors may also kill cancer cells without an ARID1A mutation when taken with another type of anti-cancer drug called PARP inhibitors.

ATARI will investigate whether giving people the ATR inhibitor ceralasertib, either alone or in combination with the PARP-inhibitor olaparib, can help shrink their cancer.

Who is included in the study?

ATARI includes people with rare gynaecological cancers which have returned after treatment. People with the following types of cancer may join the trial:

  • Clear cell (ovarian, endometrial or endometriosis-related)
  • Endometrioid (ovarian or endometrial)
  • Carcinosarcoma (ovarian or endometrial)
  • Cervical cancers (adenocarcinoma or squamous cell)

Up to 116 participants will join the trial at NHS hospitals in the UK and hospitals in France and Canada.

What are the study treatments?

When people join the trial, a sample of their cancer will be tested to find out whether there is an ARID1A mutation.

  • Participants with clear cell cancers who have an ARID1A mutation will receive treatment with ceralasertib.
  • Participants with clear cell cancers who do not have an ARID1A mutation will receive ceralasertib and olaparib.
  • Participants with other rare types of gynaecological cancers will receive ceralasertib and olaparib, whether they have an ARID1A mutation or not.

Participants have regular check-ups during and after their treatment and we collect information about how they are getting on until the study is completed.

Further information for participants

Patient Information Sheet Cohort 1a

Patient Information Sheet Cohort 1b

Patient Information Sheet Cohort 2

Patient Information Sheet Cohort 3

Patient Information Sheet Tissue Screening

A detailed summary is available on Cancer Research UK’s website

Further information for healthcare professionals

Trial Summary

Contact details and regulatory information

ICR-CTSU scientific lead: Professor Judith Bliss 

Trial management contact: [email protected]

Sponsor: The Institute of Cancer Research

Trial identifiers

EUDRACT number: 2018-003779-36

REC reference: 19/LO/1082

CPMS ID: 42436

ClinicalTrial.gov: NCT04065269

Publications and presentations

There have been no presentations or publications to date.

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