Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-02 @ 3:32 PM
Study NCT ID:
NCT04065269
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2019-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ATr Inhibitor in Combination With Olaparib/Durvalumab (MEDI4736) in Gynaecological Cancers With ARId1A Loss or no Loss
Sponsor:
Institute of Cancer Research, United Kingdom
Organization:
Study Overview
Official Title:
ATARI: ATr Inhibitor in Combination With Olaparib/Durvalumab (MEDI4736) in Gynaecological Cancers With ARId1A Loss or no Loss
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATARI
Brief Summary:
ATARI trial tests the ATR inhibitor drug ceralasertib (AZD6738) alone and in combination with either a PARP inhibitor drug called olaparib, or an anti-PD-L1 immunotherapy called durvalumab (MEDI4736) in patients with relapsed gynaecological cancers to assess the response in groups of patients selected based on their cancer cell subtype and the presence of an abnormality in the ARID1A gene.
Detailed Description:
ATARI is a multi-centre, open-label, multiple two-stage parallel cohorts phase II clinical trial for patients with relapsed gynaecological cancers, with ARID1A-deficient ('loss') and "no loss."
The trial tests the ATR inhibitor drug ceralasertib (AZD6738) alone and in combination with either a PARP inhibitor drug called olaparib, or an anti-PD-L1 immunotherapy called durvalumab (MEDI4736) to assess the response 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 ceralasertib. 1B - Women with clear cell subtype with (ovarian/uterus) ARID1A loss treated with ceralasertib and 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 ceralasertib and olaparib. 4 - Women with endometrial cancers (serous, clear cell, endometroid, carcinosarcoma) with ARID1A loss treated with ceralasertib and durvalumab. 5 - Women with endometrial cancers (serous, clear cell, endometroid, carcinosarcoma) with no ARID1A loss treated with ceralasertib and durvalumab.
The trial tests the ATR inhibitor drug ceralasertib (AZD6738) alone and in combination with either a PARP inhibitor drug called olaparib, or an anti-PD-L1 immunotherapy called durvalumab (MEDI4736) to assess the response 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 ceralasertib. 1B - Women with clear cell subtype with (ovarian/uterus) ARID1A loss treated with ceralasertib and 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 ceralasertib and olaparib. 4 - Women with endometrial cancers (serous, clear cell, endometroid, carcinosarcoma) with ARID1A loss treated with ceralasertib and durvalumab. 5 - Women with endometrial cancers (serous, clear cell, endometroid, carcinosarcoma) with no ARID1A loss treated with ceralasertib and durvalumab.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2018-003779-36 | EUDRACT_NUMBER | None | View |