Ignite Creation Date:
2024-05-06 @ 12:48 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01661868
Status:
WITHDRAWN
Last Update Posted:
2012-08-21
First Post:
2011-10-24
Brief Title:
Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase II Study of Single Agent Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer With No Prior PARP Exposure or Prior PARP Inhibitor Exposure
Status:
WITHDRAWN
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drug not available
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is a way of gaining new knowledge about a drug called olaparib in women who have either 1never received a PARP inhibitor before to treat ovarian cancer group 1 or 2participants who have received a PARP inhibitor before to treat ovarian cancer with the exception of olaparib group 2 PARP inhibitors are drugs tht prevent cancer cells from repairing their DNA In this research study we are looking to see how well the drug olaparib works in women who have never received a PARP inhibitor for recurrent ovarian cancer as well as those who have received a prior PARP inhibitor and whose cancer has re-grown after receiving that PARP inhibitor
Detailed Description:
Olaparib tablets will be taken twice daily orally in treatment cycles lasting 4 weeks
On days 1 8 12 and 22 of the first 2 cycles and day 1 of all other cycles subjects will have a physical exam be asked questions about their general health and specific questions about any problems they might be having and any medications they are taking
Tumor will be assess by either CT or MRI scan every 2 cycles every 2 months Tumor biopsies will be optional in this study Only participants that have received a PARP inhibitor in the past will be asked to have a biopsy of their tumor
On days 1 8 12 and 22 of the first 2 cycles and day 1 of all other cycles subjects will have a physical exam be asked questions about their general health and specific questions about any problems they might be having and any medications they are taking
Tumor will be assess by either CT or MRI scan every 2 cycles every 2 months Tumor biopsies will be optional in this study Only participants that have received a PARP inhibitor in the past will be asked to have a biopsy of their tumor
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