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NCT01832974 · ClinicalTrials.gov registry record · Phase 1
Possible New Therapy for Advanced Cancer
A Phase 1 study, sponsored by INSYS Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01832974: Clinical Trial Phase 1 study, sponsored by INSYS Therapeutics.
NCT01832974 is a Phase 1 study that was terminated before completion, run by INSYS Therapeutics. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01832974, a Phase 1 study, was terminated before completion, sponsored by INSYS Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
IL-13-PE is a chemical similar to one made by the body that is connected to a toxin to specifically attack cancer cells. Researchers want to look at different doses of IL-13-PE to find one that may be safe and effective against cancer that has returned, spread to other organs, or that cannot be surgically removed. Participants will receive physical exams and report side effects. Blood and urine samples will be collected. Imaging studies, tissue samples, and other tests will be used to study the tumor before the start of treatment and during the study. IL-13-PE therapy will be given to each participant on days 1, 3 and 5 of each monthly cycle for up to 4 monthly cycles. The study will be done in two parts, with a six-month period between them. If the cancer continues to grow, participants will stop taking IL-13-PE. If the cancer continues to shrink or not grow the study will continue, even into a follow-up period after the second part of the study. The first part of this study will determine how much IL-13-PE can be tolerated. For this part, the study is recruiting adult patients with various types of cancer. After six participants have taken the lowest dose with no more than one experiencing dose-limiting toxicity, two participants may begin the study taking the medium dose. If they tolerate the medium dose for a month, up to four more may begin at that dose. When at least three participants have tolerated the medium dose, two may attempt the highest dose. When they have tolerated the highest dose for one monthly cycle, 1-4 more may begin the study, receiving the highest dose. Adrenal cortex cancer (ACC) is a rare tumor in the gland above the kidney. It affects only 1-2 people per million each year and causes hormone problems. This tumor affects children under age 5 and adults aged 30-40, causing death within five years for up to 80% of them. During the second part of the study, all participants will be ACC patients. They will receive the highest dose tolerated
Interventions
- DRUG IL-13-PE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2012-12 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
Why NCT01832974 stopped before completion
NCT01832974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which IL-13-PE is the first listed.
NCT01832974 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01832974 about?
NCT01832974 is a clinical study titled "Possible New Therapy for Advanced Cancer". IL-13-PE is a chemical similar to one made by the body that is connected to a toxin to specifically attack cancer cells. Researchers want to look at different doses of IL-13-PE to find one that may be safe and effective against cancer that has returned, spread to other organs, or that cannot be surg...
What is the current status of trial NCT01832974?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2012-12. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01832974?
The interventions under investigation include: IL-13-PE (DRUG).
Who is sponsoring clinical trial NCT01832974?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01832974's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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