Ignite Creation Date:
2024-05-06 @ 1:35 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04065269
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2019-08-01
Brief Title:
ATr Inhibitor in Combination With OlaparibDurvalumab MEDI4736 in Gynaecological Cancers With ARId1A Loss or no Loss
Sponsor:
Institute of Cancer Research United Kingdom
Organization:
Institute of Cancer Research United Kingdom
Study Overview
Official Title:
ATARI ATr Inhibitor in Combination With OlaparibDurvalumab MEDI4736 in Gynaecological Cancers With ARId1A Loss or no Loss
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
Recruiting
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 ovarianuterus ARID1A loss treated with ceralasertib 1B - Women with clear cell subtype with ovarianuterus ARID1A loss treated with ceralasertib and olaparib 2 - Women with clear cell subtype ovarianuterus 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 ovarianuterus ARID1A loss treated with ceralasertib 1B - Women with clear cell subtype with ovarianuterus ARID1A loss treated with ceralasertib and olaparib 2 - Women with clear cell subtype ovarianuterus 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-003779-36 | EUDRACT_NUMBER | None | None |