Trials / Completed
CompletedNCT00261391
Phase I Drug Trial for S/E of Marimastat in Disabling Malformations When no Other Options.
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (planned)
- Sponsor
- Boston Children's Hospital · Academic / Other
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Marimastat |
Timeline
- Start date
- 2000-10-01
- Completion
- 2007-10-01
- First posted
- 2005-12-05
- Last updated
- 2008-01-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00261391. Inclusion in this directory is not an endorsement.