Ignite Creation Date:
2024-05-06 @ 3:56 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02418624
Status:
COMPLETED
Last Update Posted:
2019-01-16
First Post:
2015-03-09
Brief Title:
Phase I of Carboplatin-Olaparib Followed by Olaparib Monotherapy in Advanced Cancer
Sponsor:
The Netherlands Cancer Institute
Organization:
The Netherlands Cancer Institute
Study Overview
Official Title:
A Phase I Followed by a Randomized Phase II Trial of Two Cycles Carboplatin-Olaparib Followed by Olaparib Monotherapy Versus Capecitabine in BRCA-1 or -2 Mutated Her2 Negative Advanced Breast Cancer as First Line Treatment
Status:
COMPLETED
Status Verified Date:
2019-01
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:
REVIVAL
Brief Summary:
A phase I trial to determine the recommended phase two dose of the combination of carboplatin and olaparib
Detailed Description:
A 33 dose escalation trial of 2 cycles 21 days carboplatin and olaparib combination therapy followed by olaparib monotherapy until progression or unacceptable toxicity in patients with advanced 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 |
|---|---|---|---|
| 2013-005590-41 | EUDRACT_NUMBER | Netherlands CCMO | None |
| NL5061003114 | OTHER | None | None |