Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261391
Status:
COMPLETED
Last Update Posted:
2008-01-09
First Post:
2005-12-02
Brief Title:
Phase I Drug Trial for SE of Marimastat in Disabling Malformations When no Other Options
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Phase I Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Marimastat in Patients With Disabling Malformations and No Other Treatment Options
Status:
COMPLETED
Status Verified Date:
2005-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
3 patients were enrolled in each of 3 study cohorts There three cohorts were given differing incrementally larger doses of this phase I drug The same safety measures are being obtained on all patients Efficacy measures were individualized as enrolllees do not have the same underlying vascular anomaly The study is structured to include a 24 month drug-phase and a 24 month follow-up phase The study is now closed to enrollment
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