Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
Study NCT ID:
NCT00412412
Status:
COMPLETED
Last Update Posted:
2012-06-08
First Post:
2006-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CNF2024 (BIIB021) HER2- (QD) HER2+ (BIW w/Herceptin) PK/PD Study
Sponsor:
Biogen
Organization:
Study Overview
Official Title:
A Ph1 Open-Label,Dose-Escalation,Safety,PK & PD Study of CNF2024 as a Single-Agent Treatment in Subjects w/HER2- Adv Breast Cancer or in Combo w/Trastuzumab in Subjects w/HER2+ Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2011-12
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:
The goal of this clinical research study is to study the drug CNF2024 as a single agent or in combination with trastuzumab in patients with advanced breast cancer and to:
* find the highest dose of the drug CNF2024 as a single agent or in combination with trastuzumab that can be given safely
* measure levels of CNF2024 as a single agent or in combination with trastuzumab in blood
* determine if CNF2024 as a single agent or in combination with trastuzumab can stop breast cancer cells from growing
* find the highest dose of the drug CNF2024 as a single agent or in combination with trastuzumab that can be given safely
* measure levels of CNF2024 as a single agent or in combination with trastuzumab in blood
* determine if CNF2024 as a single agent or in combination with trastuzumab can stop breast cancer cells from growing
Detailed Description:
A Phase 1 Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CNF2024 as a Single-Agent Treatment in Subjects with HER2- Advanced Breast Cancer or in Combination with Trastuzumab in Subjects with HER2+ Advanced Breast Cancer
Study Oversight
Has Oversight DMC:
False
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?: