Ignite Creation Date:
2024-05-06 @ 1:42 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01874353
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2013-06-07
Brief Title:
Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Phase III Randomised Double Blind Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03079687
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
None
Brief Summary:
A Phase III randomised double-blind placebo-controlled multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer HGSOC patients including patients with primary peritoneal and or fallopian tube cancer or high grade endometrioid cancer with BRCA mutations documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious known or predicted to be detrimentallead to loss of function who have responded following platinum based chemotherapy
Detailed Description:
Comparison of olaparib against a placebo in patients with ovarian cancer whose cancer has already improved by taking platinum based chemotherapy The patients must also have a fault in their DNA which codes for the BRCA protein The BRCA protein helps mend broken DNA in the cells of the body if this protein doesnt work properly it can increase the chance of getting cancer The aim of this study is to see whether patients taking olaparib tablets last longer until their cancer gets worse compared to those taking the placebo tablet The study is also looking to see if there is an overall improvement to how long the patients survive whilst taking olaparib tablets compared to the placebo tablets and the quality of their life whilst living with ovarian cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 2013-001211-75 | EUDRACT_NUMBER | None | None |