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NCT01417546 · ClinicalTrials.gov registry record · Phase 1
NHS-IL12 for Solid Tumors
A Phase 1 study of Epithelial Neoplasms, Malignant and Epithelial Tumors, Malignant, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT01417546: Completed Phase 1 study of Epithelial Neoplasms, Malignant and Epithelial Tumors, Malignant, sponsored by National Cancer Institute (NCI).
NCT01417546 is a Phase 1 study of Epithelial Neoplasms, Malignant and Epithelial Tumors, Malignant that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01417546, a Phase 1 study of Epithelial Neoplasms, Malignant and Epithelial Tumors, Malignant, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- The experimental drug NHS-IL12 may help the immune system become more active and kill cancer cells that have not responded to standard treatments. NHS-IL12 has been designed to cause less severe side effects than other anticancer drugs, and may be more effective. More research is needed to test NHS-IL12 in people who have solid tumors that have not responded to treatment. Objectives: \- To test the safety and effectiveness of NHS-IL12 as a treatment for solid tumors which have not responded to standard treatments. Eligibility: \- Individuals at least 18 years of age with solid tumors that have not responded to standard treatments. Design: * Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies. * Participants will receive NHS-IL12 injection every 4 weeks, and will stay in the hospital for at least one day to be monitored with frequent blood tests. * Participants will have periodic blood samples taken before treatment and during the first week after treatment for the first two cycles. They will then have blood samples taken before treatment for the rest of the cycles.
Primary Outcome
Determination of DLTs and MTD.
Conditions Studied
Interventions
- DRUG NHS-IL-12
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2011-12-12 |
| Est. Completion | 2021-10-14 |
| Phase | Phase 1 |
What the finished NCT01417546 record still lists
NCT01417546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 3 conditions, with Epithelial Neoplasms, Malignant appearing as the primary indexed condition, and to 1 intervention - of which NHS-IL-12 is the first listed.
NCT01417546 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01417546 about?
NCT01417546 is a clinical study titled "NHS-IL12 for Solid Tumors". Background: \- The experimental drug NHS-IL12 may help the immune system become more active and kill cancer cells that have not responded to standard treatments. NHS-IL12 has been designed to cause less severe side effects than other anticancer drugs, and may be more effective. More research is nee...
What is the current status of trial NCT01417546?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2011-12-12. Estimated completion is 2021-10-14.
What conditions does trial NCT01417546 study?
This clinical trial studies the following conditions: Epithelial Neoplasms, Malignant, Epithelial Tumors, Malignant, Malignant Mesenchymal Tumor.
What interventions are being tested in trial NCT01417546?
The interventions under investigation include: NHS-IL-12 (DRUG).
Who is sponsoring clinical trial NCT01417546?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01417546 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01417546's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 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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