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ATR Inhibitor

Ceralasertib + Olaparib/Durvalumab for Gynecological Cancers (ATARI Trial)

Phase 2

Recruiting

Led By Susana Banerjee

Research Sponsored by Institute of Cancer Research, United Kingdom

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ovarian and endometrial clear cell (>50% clear cell carcinoma with no serous differentiation)

Carcinosarcomas Note: patients who have an original diagnosis based on cytology only will not be eligible for entry into the study unless a biopsy confirming above histology is performed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment until disease progression - estimated 6-9 months, up to max study period (36 months)

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a new drug called ceralasertib in patients with relapsed gynaecological cancers. The drug is being tested alone and in combination with other drugs to see how patients

Who is the study for?

This trial is for women with certain types of gynecological cancers (like ovarian, endometrial clear cell, and others) that have worsened after treatment. They must have a specific gene abnormality (ARID1A), measurable disease by scans, and be in good physical condition with a life expectancy over 16 weeks.

What is being tested?

The ATARI trial is testing the effectiveness of ceralasertib alone or combined with olaparib or durvalumab on patients whose cancer cells show ARID1A loss. It aims to see how well these drugs work based on the patient's cancer subtype.

What are the potential side effects?

Possible side effects include fatigue, nausea, skin reactions from immunotherapy (durvalumab), blood count changes from the ATR inhibitor (ceralasertib), and potential organ damage related to PARP inhibition (olaparib).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is mostly clear cell type without serous features.

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My cancer is confirmed as carcinosarcoma through a biopsy.

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My cancer has grown since my last cancer treatment.

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My physical ability has been stable or better for the last 2 weeks.

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I can provide a tissue sample from my diagnosis or relapse for testing.

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My cancer can be measured by scans and does not rely solely on CA125 levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment until disease progression - estimated 6-9 months, up to max study period (36 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment until disease progression - estimated 6-9 months, up to max study period (36 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment until disease progression - estimated 6-9 months, up to max study period (36 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Confirmed overall objective response rate (complete or partial response) as defined by RECIST version 1.1.

Secondary study objectives

Disease control rate

Duration of disease control

Overall Survival (OS)

+3 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: 5: ceralasertib (AZD6738) + durvalumabExperimental Treatment2 Interventions

Women with endometrial cancers (serous, clear cell, endometroid, carcinosarcoma) with NO loss of ARID1A.

Group II: 4: ceralasertib (AZD6738) + durvalumabExperimental Treatment2 Interventions

Women with endometrial cancers (serous, clear cell, endometroid, carcinosarcoma) with ARID1A loss.

Group III: 3: ceralasertib (AZD6738) + olaparibExperimental Treatment2 Interventions

Women with other rare relapsed gynaecological cancers (endometrioid ovarian carcinoma, endometrioid endometrial carcinoma, cervical adenocarcinoma, cervical squamous, ovarian carcinosarcoma and endometrial carcinosarcoma) irrespective of ARID1A status, treated with AZD6738 in combination with olaparib.

Group IV: 2: ceralasertib (AZD6738) + olaparibExperimental Treatment2 Interventions

Women with relapsed ovarian (fallopian tube / primary peritoneal) and endometrial (uterus) clear cell carcinomas with NO loss of ARID1A expression treated with AZD6738 in combination with olaparib.

Group V: 1B: ceralasertib (AZD6738) + olaparibExperimental Treatment2 Interventions

In second stage of trial, opening of this cohort depends on response rate in cohort 1A during first stage of trial. Women with relapsed ovarian (fallopian tube / primary peritoneal) and endometrial (uterus) clear cell carcinomas with loss of ARID1A expression treated with AZD6738 in combination with olaparib.

Group VI: 1A: ceralasertib (AZD6738)Experimental Treatment1 Intervention

Women with relapsed ovarian (fallopian tube / primary peritoneal) and endometrial (uterus) clear cell carcinomas with loss of ARID1A expression treated with single agent AZD6738.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ceralasertib

2017

Completed Phase 1

~40

Durvalumab

2017

Completed Phase 2

~3750