Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT01724320
Status:
UNKNOWN
Last Update Posted:
2012-11-09
First Post:
2012-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I, First-in-man Study of OTX008 Given Subcutaneously as a Single Agent to Patients With Advanced Solid Tumors
Sponsor:
Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Organization:
Study Overview
Official Title:
A Phase I, First-in-man Study of OTX008 Given Subcutaneously as a Single Agent to Patients With Advanced Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2012-11
Last Known Status:
RECRUITING
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 purpose of this study is to determine the recommended dose (RD) for further phase II studies, of the Galectin-1 inhibitor OTX008 given subcutaneously in patients with advanced solid tumors
Detailed Description:
Overexpression of galectin-1 protein is well documented in different types of cancers, with associated bad prognostic and enhanced metastases spreading.
In-vitro/in-vivo preclinical studies showed that OTX008 inhibits galectin-1 expression. In different cancer models in animals, OTX008 reduced tumor growing and metastases spreading and it was observed a blood vessels architecture normalization.
Thus, OTX008 appears to be an innovating approach to treat cancers and this clinical phase I study aims to evaluate OTX008 therapy in patients with advanced solid tumors.
In-vitro/in-vivo preclinical studies showed that OTX008 inhibits galectin-1 expression. In different cancer models in animals, OTX008 reduced tumor growing and metastases spreading and it was observed a blood vessels architecture normalization.
Thus, OTX008 appears to be an innovating approach to treat cancers and this clinical phase I study aims to evaluate OTX008 therapy in patients with advanced solid tumors.
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?: