Phase I Drug Trial for S/E of Marimastat in Disabling Malformations When no Other Options.

Vascular Anomalies Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Vascular Anomalies
• Vascular Malformations

• NCT number: NCT00261391
• Study type: Interventional
• Source: Children's Hospital Boston
• Status: Completed
• Phase: Phase 1
• Start date: October 2000
• Completion date: October 2007