Ignite Creation Date:
2024-05-05 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00526045
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2007-09-05
Brief Title:
Phase I-II Study to Determine the Maximum Tolerated Dose MTD of AUY922 in Advanced Solid Malignancies and Efficacy in HER2 or ER Locally Advanced or Metastatic Breast Cancer Patients
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase I Dose Escalation Multi-center Open-label Study of AUY922 Administered IV on a Once Weekly Schedule in Adult Patients With Advanced Solid Malignancies Including Phase II Expansion Arms in Patients With Either HER2 Positive or ER Positive Locally Advanced or Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-05
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 III open-label multicenter study of AUY922 administered intravenously in patients with advanced solid malignancies to determine the maximum tolerated dose Phase II expansion arms will investigate efficacy in patients with either HER2 positive or ER positive locally advanced or metastatic breast cancer Additional patients with advanced solid malignancies will also be investigated in a separate expansion arm Safety pharmacokinetics and pharmacodynamics will be assessed
Detailed Description:
None
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 |
|---|---|---|---|
| 2006-002766-20 | EUDRACT_NUMBER | None | None |