Ignite Creation Date:
2024-05-05 @ 11:28 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01339650
Status:
COMPLETED
Last Update Posted:
2018-01-02
First Post:
2011-04-04
Brief Title:
Study of ABT-767 in Subjects With Breast Cancer 1 and Breast Cancer 2 BRCA 1 and BRCA 2 Mutations and Solid Tumors or High Grade Serous Ovarian Fallopian Tube or Primary Peritoneal Cancer
Sponsor:
AbbVie prior sponsor Abbott
Organization:
AbbVie
Study Overview
Official Title:
A Phase 1 Study of ABT-767 in BRCA1 or BRCA2 Mutation Carriers With Advanced Solid Tumors and in Subjects With High Grade Serous Ovarian Fallopian Tube or Primary Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2017-12
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:
None
Brief Summary:
This is a Phase 1 dose escalation trial evaluating the tolerability pharmacokinetics and pharmacodynamics of ABT-767 in subjects with advanced Breast Cancer 1 or 2 gene BRCA1 or BRCA2-mutated solid tumors and high grade serous ovarian fallopian tube or primary peritoneal cancer
Detailed Description:
This is a Phase 1 dose escalation trial evaluating the tolerability pharmacokinetics and pharmacodynamics of ABT-767 in subjects with advanced BRCA1 or BRCA2-mutated solid tumors and high grade serous ovarian fallopian tube or primary peritoneal cancer ABT-767 is a potent oral inhibitor of the enzymes poly ADP-ribose polymerase 1 and 2 PARP-1 and PARP-2 Malignancies with deficiencies in homologous repair such as BRCA-1 and BRCA-2 deficient tumors are more dependent on PARP for deoxyribonucleic acid DNA repair than normal cells and thus are thought to be more sensitive to PARP inhibition The study design is a single-arm dose escalation study to determine dose-limiting toxicities maximum tolerated dose and the recommended Phase 2 dose RPTD of orally administered ABT-767 in subjects with BRCA mutations and malignancies In order to further evaluate the safety and tolerability of ABT-767 at the RPTD 20 additional subjects will be enrolled in an expanded safety cohort consisting of BRCA1- or BRCA2-mutated Breast cancer and Ovarian cancer
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-020795-37 | EUDRACT_NUMBER | None | None |