Ignite Creation Date:
2024-05-06 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03434158
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2018-01-26
Brief Title:
Olaparib Maintenance in Patients With MCRPC After Docetaxel Treatment Reaching Partial or Stable Response IMANOL
Sponsor:
Spanish Oncology Genito-Urinary Group
Organization:
Spanish Oncology Genito-Urinary Group
Study Overview
Official Title:
Phase II Trial Evaluating Olaparib Maintenance in Patients With MCRPC After Docetaxel Treatment Reaching Partial or Stable Response
Status:
COMPLETED
Status Verified Date:
2022-10
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:
IMANOL
Brief Summary:
A number of important systemic therapies have been developed to treat mCRPC and have received regulatory approval and now comprise the current therapeutic landscape Durable and complete response following first-line chemotherapy in patients with advanced PC are uncommon Most patients will ultimately experience disease progression within 6-9 months after initial response Optimal Second line therapy in mCRPC is not well established and several options are possible
Olaparib has demonstrated anti-tumour activity in non-comparative studies in patients with germline BReast CAncer gene gBRCA mutated cancers including ovarian breast pancreas and prostate Olaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed Breast Cancer gene-mutated germline andor somatic high grade serous epithelial ovarian fallopian tube or primary peritoneal cancer who are in response complete response or partial response to platinum-based chemotherapy
This phase II study is developed to assess the effect of maintenance treatment with olaparib on radiologic progression free survival rPFS in patients with mCRPC who have received at least 6 cycles of docetaxel and achieved partial or complete response or disease stabilization according RECIST 11 criteria and PCWG3
Olaparib has demonstrated anti-tumour activity in non-comparative studies in patients with germline BReast CAncer gene gBRCA mutated cancers including ovarian breast pancreas and prostate Olaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed Breast Cancer gene-mutated germline andor somatic high grade serous epithelial ovarian fallopian tube or primary peritoneal cancer who are in response complete response or partial response to platinum-based chemotherapy
This phase II study is developed to assess the effect of maintenance treatment with olaparib on radiologic progression free survival rPFS in patients with mCRPC who have received at least 6 cycles of docetaxel and achieved partial or complete response or disease stabilization according RECIST 11 criteria and PCWG3
Detailed Description:
None
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 |
|---|---|---|---|
| 2017-001469-26 | EUDRACT_NUMBER | None | None |