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NCT01441115 · ClinicalTrials.gov registry record · Phase 1
ECI301 and Radiation for Advanced or Metastatic Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT01441115: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01441115 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01441115, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
Background: \- ECI301 is a drug that may help make cancer cells more visible to the immune system after radiation. The drug may also help the immune system destroy the cancer at sites that have not received radiation therapy. Researchers want to study ECI301 in people with advanced cancer or cancer that has spread in the body (metastatic). Objectives: \- To test ECI301 with radiation therapy for advanced or metastatic cancer. Eligibility: \- People at least 18 years of age with either metastatic or advanced cancer that may benefit from radiation therapy. Design: * Participants will be screened with a medical history and physical exam. They will also have blood and urine tests, and imaging studies. * All participants will have radiation therapy 5 days a week for 2 weeks. * They will have different doses of ECI301 to test its safety and effectiveness. ECI301 will be given in a vein during the second week of radiation therapy. Frequent blood tests and imaging studies will monitor the treatment. * After participants have ECI301, tumor samples may be taken from the site that had radiation and another site that did not have radiation. * Follow-up visits will include blood tests and imaging studies.
Primary Outcome
MTD is defined as the highest dose level at which no more than 1 of 6 participants experience dose-limiting toxicity (DLT) during treatment or the first three weeks after treatment, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of the drug. Examples of DLT is any grade 3 or greater non-hematologic toxicity, ang grade 3 neutropenia or thrombocytopenia, any grade 4 anemia, and toxicity requiring a cumulative radiation treatment delay of 4 or more days.
Interventions
- PROCEDURE Radiation Therapy
- DRUG ECI301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2011-09-06 |
| Est. Completion | 2013-04-24 |
| Phase | Phase 1 |
Why NCT01441115 stopped before completion
NCT01441115 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Radiation Therapy is the first listed.
NCT01441115 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01441115 about?
NCT01441115 is a clinical study titled "ECI301 and Radiation for Advanced or Metastatic Cancer". Background: \- ECI301 is a drug that may help make cancer cells more visible to the immune system after radiation. The drug may also help the immune system destroy the cancer at sites that have not received radiation therapy. Researchers want to study ECI301 in people with advanced cancer or cancer...
What is the current status of trial NCT01441115?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2011-09-06. Estimated completion is 2013-04-24.
What interventions are being tested in trial NCT01441115?
The interventions under investigation include: Radiation Therapy (PROCEDURE), ECI301 (DRUG).
Who is sponsoring clinical trial NCT01441115?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01441115's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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