Study of Vintafolide (MK-8109, EC145) for the Treatment of Recurrent or Refractory Solid Tumors (MK-8109-006, EC-FV-01)
NCT00308269 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2014-12-19
Summary
This is a Phase I clinical trial evaluating the safety and tolerability of escalating doses of vintafolide (EC145) in participants with relapsed or refractory advanced tumors. The primary objective of this study is to determine the safety and maximum tolerated dose of vintafolide given by intravenous bolus or infusion. The efficacy of the treatment will also be measured.
Conditions
Interventions
- DRUG
-
Vintafolide IV Bolus
Vintafolide is a folic acid desacetylvinblastine hydrazide conjugate
- DRUG
-
Vintafolide IV Infusion
Vintafolide is a folic acid desacetylvinblastine hydrazide conjugate
Sponsors & Collaborators
-
Endocyte
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-03-31
- Primary Completion
- 2007-08-31
- Completion
- 2008-07-31
Countries
- United States
Study Locations
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