Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001683
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Phase I Study of Oral COL-3 NSC-683551 a Matrix Metalloproteinase Inhibitor in Patients With Refractory Metastatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Study of Oral COL-3 NSC-683551 a Matrix Metalloproteinase Inhibitor in Patients With Refractory Metastatic Cancer
Status:
COMPLETED
Status Verified Date:
2003-08
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:
Matrix metalloproteinases MMPs are a class of membrane bound enzymes that are involved in the degradation of the extracellular matrix MMP-2 and MMP-9 have been associated with the progression of cancer It is hypothesized than an imbalance between MMPs and MMP inhibitors allows the destruction of the extracellular matrix and enhances the ability of the tumor cells to grow and metastasize By inhibiting MMPs it is thought that angiogenesis and metastasis can be inhibited This is a phase I study of COL-3 an oral matrix metalloproteinase inhibitor in patients with refractory metastatic cancer COL-3 is a chemically modified tetracycline derivative Patients must have clinically progressive disease documented within 1 month prior to entry to be eligible for treatment Patients must have also failed therapy of proven efficacy for their disease and have an ECOG performance status of less or equal than 2 Patients must be willing to travel from their home to the NIH for follow-up visits Patients with brain metastases or primary CNS malignancies are not eligible Concurrent therapy for their cancer ie radiation therapy chemotherapy etc will preclude participation We will be defining the maximum tolerated dose the toxicity profile characterizing the pharmacokinetics and evaluating the effect of COL-3 on several biological endpoints
Detailed Description:
Matrix metalloproteinases MMPs are a class of membrane bound enzymes that are involved in the degradation of the extracellular matrix MMP-2 and MMP-9 have been associated with the progression of cancer It is hypothesized that an imbalance between MMPs and MMP inhibitors allows the destruction of the extracellular matrix and enhances the ability of the tumor cells to grow and metastasize By inhibiting MMPs it is thought that angiogenesis and metastasis can be inhibited This is a phase I study of COL-3 an oral matrix metalloproteinase inhibitor in patients with refractory metastatic cancer COL-3 is a chemically modified tetracycline derivative Patients must have clinically progressive disease documented within 1 month prior to entry to be eligible for treatment Patients must have also failed therapy of proven efficacy for their disease and have an ECOG performance status of less than or equal to 2 Patients must be willing to travel from their home to the NIH for follow-up visits Patients with brain metastases or primary CNS malignancies are not eligible Concurrent therapy for their cancer ie radiation therapy chemotherapy etc will preclude participation We will be defining the maximum tolerated dose the toxicity profile characterizing the pharmacokinetics and evaluating the effect of COL-3 on several biological endpoints
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 |
|---|---|---|---|
| 98-C-0015 | None | None | None |