Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04502602
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2020-08-04
Brief Title:
Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
A Phase 11b Clinical Trial of Niraparib and Neratinib in Advanced Solid Tumors With an Expansion Cohort in Platinum-resistant Ovarian Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
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:
iNNOVATE
Brief Summary:
To determine the recommended phase 2 dose RP2D of niraparib and neratinib in combination in patients with advanced solid tumors during Phase 1 To evaluate clinical benefit 4-month progression-free survival PFS of niraparib and neratinib in patients with platinum-resistant ovarian cancer in Phase 1b
Detailed Description:
This study is a single-arm open-label phase 11b trial to determine the RP2D of neratinib and niraparib when given in combination to patients with advanced solid tumors The RP2D will be identified during the phase 1 dose escalation portion of the study using a modified 33 design and evaluated in a phase 1b dose expansion cohort of up to 12 patients with platinum-resistant ovarian cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2020-05315 | OTHER | NCI CTRP | None |