Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443573
Status:
SUSPENDED
Last Update Posted:
2008-05-07
First Post:
2007-03-02
Brief Title:
Safety Study of Recombinant NAPc2 to Prevent Tumor Progression and Metastases in Metastatic Colon Cancer
Sponsor:
ARCA Biopharma Inc
Organization:
ARCA Biopharma Inc
Study Overview
Official Title:
Multicenter Two-Stage Study to Evaluate the Safety and Efficacy of Second-Line Metastatic Colorectal Carcinoma Treatment With Recombinant NAPc2
Status:
SUSPENDED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company suspended development of product
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter two-stage trial with the goal of evaluating up to 100 subjects This trial will be performed to initiate identification of a safe and effective dose of twice-weekly subcutaneous rNAPc2 for the second-line treatment of metastatic colorectal carcinoma in combination with contemporary 5-FU-based chemotherapy
Detailed Description:
Cytotoxic chemotherapy combining 5-fluorouracil and leucovorin with irinotecan FOLFIRI or oxaliplatin FOLFOX or more recently treatment with XELOX Roche capecitabine oxaliplatin has been the main approach for the treatment of metastatic colorectal carcinoma mCRC but with the advent of targeted therapies biologic treatments are becoming an area of intense interest Tissue factor TF is a transmembrane glycoprotein expressed by upwards of 85 of mCRCs
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