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NCT00592046 · ClinicalTrials.gov registry record · Phase 1
A Phase I Trial of ZIO-101 in Hematologic Cancers
A Phase 1 study, sponsored by Alaunos Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00592046 is a Phase 1 study that has completed, run by Alaunos Therapeutics. The registered enrollment target is 12 participants.
The verdict
NCT00592046, a Phase 1 study, has completed, sponsored by Alaunos Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study uses a new investigational (not yet approved by the FDA for widespread use) drug called ZIO-101, an organic arsenical. You must be diagnosed to have relapsed/refractory leukemia or lymphoma (blood cancer) and have tried other standard therapies. This study is designed to determine whether ZIO-101 may be given safely. The study will also test whether ZIO-101 helps to treat blood cancer. We anticipate that approximately 22 to 35 patients will take part in this study. Arsenic has been used as a medicinal agent for centuries in many different cultures. Most recently in the United States, an inorganic arsenic compound was approved by the FDA for the treatment of patients with relapsed acute promyelocytic leukemia (APL). However, use of inorganic arsenic is limited by a narrow range of activity and systemic toxicity, most notably of the cardiac system. ZIO-101 is an organic arsenic derivative. In vitro testing in both the National Cancer Institute (NCI) cancer cell panel and in vivo testing in a leukemia animal model demonstrated substantial activity of SGLU against hematologic cancers. In vitro testing of SGLU using the NCI human cancer cell panel also detected activity against lung, colon and brain cancers, melanoma, and ovary and kidney cancers. Moderate activity was seen against breast and prostate cancers cells. Data suggest that organic arsenic generates reactive oxygen species in the cells to induce apoptosis and cell cycle arrest.
Interventions
- DRUG ZIO-101 (Darinaparsin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2005-05 |
| Est. Completion | 2008-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00592046
The ClinicalTrials.gov registry entry for NCT00592046 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alaunos Therapeutics, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ZIO-101 (Darinaparsin) is the first listed.
NCT00592046 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00592046 about?
NCT00592046 is a clinical study titled "A Phase I Trial of ZIO-101 in Hematologic Cancers". This study uses a new investigational (not yet approved by the FDA for widespread use) drug called ZIO-101, an organic arsenical. You must be diagnosed to have relapsed/refractory leukemia or lymphoma (blood cancer) and have tried other standard therapies. This study is designed to determine whethe...
What is the current status of trial NCT00592046?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2005-05. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00592046?
The interventions under investigation include: ZIO-101 (Darinaparsin) (DRUG).
Who is sponsoring clinical trial NCT00592046?
This trial is sponsored by Alaunos Therapeutics, which has 22 total clinical trials registered on ClinicalTrials.gov.
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