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NCT01664000 · ClinicalTrials.gov registry record · Phase 1
A Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin in Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Cellceutix Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT01664000: Completed Phase 1 study, sponsored by Cellceutix Corporation.
NCT01664000 is a Phase 1 study that has completed, run by Cellceutix Corporation. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01664000, a Phase 1 study, has completed, sponsored by Cellceutix Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
In the laboratory, Kevetrin activates p53, a tumor suppressor protein that has an important role in protecting the body. p53 functions by activating proteins that repair DNA and kill cells that have genetic mutations such as in cancers. Research experiments showed that when cancer cells were treated with Kevetrin, it activated p53 which induced p21, a protein that inhibits cancer cell growth. p53 also induced PUMA (p53 up-regulated modulator of apoptosis), a protein that causes tumor cell death. Because of these activities, slowing cancer cell growth and causing cancer cell death, Kevetrin may help to treat tumors.
Primary Outcome
A dose will be declared the MTD if at least 1 patient out of 6 patients experience a dose limiting toxicity (DLT) at the highest dose level below the maximally administered dose. Once an MTD has been established, up to 12 additional patients may be enrolled at the MTD dose level for confirmation of safety. The maximally administered dose is if 1 or more of 6 patients experience a DLT.
Interventions
- DRUG thioureidobutyronitrile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2012-10 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
What the finished NCT01664000 record still lists
NCT01664000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 1 intervention - of which thioureidobutyronitrile is the first listed.
NCT01664000 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01664000 about?
NCT01664000 is a clinical study titled "A Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin in Patients With Advanced Solid Tumors". In the laboratory, Kevetrin activates p53, a tumor suppressor protein that has an important role in protecting the body. p53 functions by activating proteins that repair DNA and kill cells that have genetic mutations such as in cancers. Research experiments showed that when cancer cells were treated...
What is the current status of trial NCT01664000?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2012-10. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01664000?
The interventions under investigation include: thioureidobutyronitrile (DRUG).
Who is sponsoring clinical trial NCT01664000?
This trial is sponsored by Cellceutix Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01664000's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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