Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that was terminated before completion, run by Erimos Pharmaceuticals. The registered enrollment target is 21 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00664586
The ClinicalTrials.gov registry entry for NCT00664586 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Erimos Pharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Terameprocol (EM-1421) is the first listed.
NCT00664586 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.