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NCT00308269 · ClinicalTrials.gov registry record · Phase 1
Study of Vintafolide (MK-8109, EC145) for the Treatment of Recurrent or Refractory Solid Tumors (MK-8109-006, EC-FV-01)
A Phase 1 study, sponsored by Endocyte.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT00308269: Completed Phase 1 study, sponsored by Endocyte.
NCT00308269 is a Phase 1 study that has completed, run by Endocyte. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00308269, a Phase 1 study, has completed, sponsored by Endocyte.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study 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.
Primary Outcome
Maximum Tolerated Dose (MTD) was defined as the highest dose that can safely be administered to a patient to produce acceptable, manageable and reversible toxicity. This level was further defined as the dose level at which no more than 1 of 6 participants had dose-limiting toxicity (DLT) and the level below the dose at which ≥2 of 6 participants had DLT.
Interventions
- DRUG Vintafolide IV Bolus
- DRUG Vintafolide IV Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2006-03 |
| Est. Completion | 2008-07 |
| Phase | Phase 1 |
What the finished NCT00308269 record still lists
NCT00308269 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Vintafolide IV Bolus is the first listed.
NCT00308269 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00308269 about?
NCT00308269 is a clinical study titled "Study of Vintafolide (MK-8109, EC145) for the Treatment of Recurrent or Refractory Solid Tumors (MK-8109-006, EC-FV-01)". 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 intravenou...
What is the current status of trial NCT00308269?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2006-03. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00308269?
The interventions under investigation include: Vintafolide IV Bolus (DRUG), Vintafolide IV Infusion (DRUG).
Who is sponsoring clinical trial NCT00308269?
This trial is sponsored by Endocyte, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00308269's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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