drugset / Trial / NCT00261391

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

NCT00261391

Phase 1 Completed 9 enrolled Boston Children's Hospital
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2000-10
Primary completion
Completion
2007-10

Drugs

EvaluationDrugModalityDoseRoute
Subject marimastat Small molecule

Indications