Clinical Trial: Phase I Drug Trial for S/E of Marimastat in Disabling Malformations When no Other Options.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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 Summary:
Sponsor: Boston Children’s Hospital
Current Primary Outcome:
- History
- Physical Examination
- Laboratory studies
- Vital Signs
- EKG
- Urine studies
Original Primary Outcome: Same as current
Current Secondary Outcome: Individualized. Change in the predetermined measure of the vascular anomaly.
Original Secondary Outcome: Same as current
Information By: Boston Children’s Hospital
Dates:
Date Received: December 2, 2005
Date Started: October 2000
Date Completion: October 2007
Last Updated: January 8, 2008
Last Verified: May 2005
