Ignite Creation Date:
2024-05-06 @ 2:06 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01968213
Status:
COMPLETED
Last Update Posted:
2023-06-09
First Post:
2013-10-17
Brief Title:
Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer ARIEL3
Sponsor:
pharmaand GmbH
Organization:
pharmaand GmbH
Study Overview
Official Title:
A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive High-Grade Serous or Endometrioid Epithelial Ovarian Primary Peritoneal or Fallopian Tube Cancer ARIEL3
Status:
COMPLETED
Status Verified Date:
2023-06
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:
ARIEL3
Brief Summary:
Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue The purpose of this study is to evaluate patient response to maintenance treatment with rucaparib versus placebo Response to treatment will be analyzed based on homologous recombination HR status of tumor samples
Detailed Description:
Rucaparib is an orally available small molecule inhibitor of poly-adenosine diphosphate ADP ribose polymerase PARP being developed for treatment of ovarian cancer associated with homologous recombination HR DNA repair deficiency HRD Clinical data have shown that ovarian cancer patients with and without evidence of a gBRCA mutation benefit from treatment with a PARP and that maintenance treatment with a PARP inhibitor following a response to platinum-based treatment increases PFS in patients with ovarian cancer While patients with a BRCA mutation derived the most benefit patients without evidence of a BRCA mutation also derived significant benefit
Patients enrolled into this study will be stratified into 3 groups based on tumor HRD status The purpose of this study is to identify which of these groups of patients will most likely benefit from treatment with rucaparib It is anticipated that rucaparib will provide therapeutic benefit and increase PFS in patients with HRD associated with a BRCA gene mutation or other HR gene alteration
Patients enrolled into this study will be stratified into 3 groups based on tumor HRD status The purpose of this study is to identify which of these groups of patients will most likely benefit from treatment with rucaparib It is anticipated that rucaparib will provide therapeutic benefit and increase PFS in patients with HRD associated with a BRCA gene mutation or other HR gene alteration
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 |
|---|---|---|---|
| 2013-000518-39 | EUDRACT_NUMBER | None | None |