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NCT00057512 · ClinicalTrials.gov registry record · Phase 1
Study of Intralesional Injection of M4N in Patients With Refractory Malignant Tumors of the Head and Neck
A Phase 1 study of Head and Neck Neoplasms, sponsored by Erimos Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT00057512 is a Phase 1 study of Head and Neck Neoplasms that has completed, run by Erimos Pharmaceuticals. The registered enrollment target is 9 participants, below the 265-participant average among 23 other Head and Neck Neoplasms trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00057512, a Phase 1 study of Head and Neck Neoplasms, has completed, sponsored by Erimos Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study will be to determine the safety and tolerability of intratumoral M4N. Patients suffering from cancer of the head and neck that is recurrent after primary treatment with surgery, radiation therapy, and/or chemotherapy may be eligible. The design is a Phase 1 dose escalation study of M4N administered intratumorally once weekly, initially for three weeks. Dose will be escalated on the starting schedule to a target of 20 mg/cm3 tumor volume and then, new patient cohorts will have their schedule extended to weekly M4N for 4 weeks. Dose escalation will continue, assuming tolerability, so that cohorts will be treated for 6 weeks, and finally, 8 weeks.
Conditions Studied
Interventions
- DRUG M4N
Study Locations (1)
South Carolina
- MUSC - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2003-01 |
| Est. Completion | 2003-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00057512
The ClinicalTrials.gov registry entry for NCT00057512 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 265-participant average among 23 other Head and Neck Neoplasms trials with a reported enrollment target (97% lower). The listed sponsor is Erimos Pharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Head and Neck Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which M4N is the first listed.
NCT00057512 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.
Frequently Asked Questions
What is clinical trial NCT00057512 about?
NCT00057512 is a clinical study titled "Study of Intralesional Injection of M4N in Patients With Refractory Malignant Tumors of the Head and Neck". The purpose of this study will be to determine the safety and tolerability of intratumoral M4N. Patients suffering from cancer of the head and neck that is recurrent after primary treatment with surgery, radiation therapy, and/or chemotherapy may be eligible. The design is a Phase 1 dose escalation ...
What is the current status of trial NCT00057512?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2003-01. Estimated completion is 2003-12.
What conditions does trial NCT00057512 study?
This clinical trial studies the following conditions: Head and Neck Neoplasms.
What interventions are being tested in trial NCT00057512?
The interventions under investigation include: M4N (DRUG).
Who is sponsoring clinical trial NCT00057512?
This trial is sponsored by Erimos Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00057512 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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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.