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NCT00664586 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Continuous Intravenous Infusion Study of Terameprocol (EM-1421) in Subjects With Refractory Solid Tumors
A Phase 1 study, sponsored by Erimos Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT00664586: Clinical Trial Phase 1 study, sponsored by Erimos Pharmaceuticals.
NCT00664586 is a Phase 1 study that was terminated before completion, run by Erimos Pharmaceuticals. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00664586, a Phase 1 study, was terminated before completion, sponsored by Erimos Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This is a Phase I continuous infusion study designed to explore if constant concentration over time adds to the effectiveness of terameprocol without increasing toxicity. It will also explore weekly dosing as an option. Tumor response assessments will be performed following every two (2) cycles of therapy. All subjects will undergo a follow-up visit 30 days following their last dose of terameprocol. Circulating tumor cells (CTC) will be quantified pre dosing and on day 15 after first dose of each cycle. Needle biopsy specimens will be taken prior to therapy and one week after first dose, if possible, to assess for tumor markers (cdc-2 and survivin). Tumor markers, for example prostate specific antigen (PSA) will also be measured on day 15 of each cycle (if elevated on study entry). Pharmacokinetic parameters will be derived from analysis of blood samples collected during the first 24 hour infusion.
Interventions
- DRUG Terameprocol (EM-1421)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2007-05 |
| Est. Completion | 2009-06 |
| Phase | Phase 1 |
Why NCT00664586 stopped before completion
NCT00664586 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which Terameprocol (EM-1421) is the first listed.
NCT00664586 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00664586 about?
NCT00664586 is a clinical study titled "A Phase 1 Continuous Intravenous Infusion Study of Terameprocol (EM-1421) in Subjects With Refractory Solid Tumors". This is a Phase I continuous infusion study designed to explore if constant concentration over time adds to the effectiveness of terameprocol without increasing toxicity. It will also explore weekly dosing as an option. Tumor response assessments will be performed following every two (2) cycles of ...
What is the current status of trial NCT00664586?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2007-05. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00664586?
The interventions under investigation include: Terameprocol (EM-1421) (DRUG).
Who is sponsoring clinical trial NCT00664586?
This trial is sponsored by Erimos Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00664586's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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