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NCT00978250 · ClinicalTrials.gov registry record · Phase 2
A Multi-Histology Phase II Study of 5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine (FdCyd + THU)
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
NCT00978250: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00978250 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 95 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00978250, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
Study Summary
Background: * Two experimental drugs, FdCyd (also called 5-fluoro-2'-deoxcytidine), and THU (also called tetrahydrouridine), are undergoing trials to test their effectiveness in treating cancer that has not responded to standard therapies. FdCyd is thought to work by changing how genes work in cancer cells. THU does not have any anticancer effects on its own, but it helps keep the other drug, FdCyd, from being broken down by the body. * These drugs are being tested in several separate clinical trials. Objectives: * To determine if FdCyd and THU can work together to control tumor growth. * To evaluate the safety and tolerability of FdCyd and THU when given together. Eligibility: \- Individuals 18 years of age and older who have advanced non-small cell lung cancer, breast cancer, bladder cancer, or head and neck cancer that has progressed after receiving standard treatment or for which no effective therapy exists. Design: * The drugs are given over 28-day periods called cycles. FdCyd and THU are given through a vein for about 3 hours each day on days 1, 5 and 8, 12 of each cycle. * Clinical Center visits: FdCyd and THU will be given through a vein on days 1, 5 and 8, 12 of each cycle. During the Clinical Center visits, researchers will perform study tests and procedures to see how the study drugs are affecting the body. * Patients will undergo a number of tests and procedures during the treatment cycle, including physical examinations, blood and urine samples for standard tests, imaging studies (ultrasound, magnetic resonance imaging (MRI) or computed tomography (CT) scans) to evaluate tumor growth, and blood and urine samples to evaluate the amount of FdCyd and THU in the body and the body's response to the drugs. * Patients may continue to receive FdCyd and THU if their cancer does not grow, if they do not have too many side effects, and if they are willing to do so.
Interventions
- DRUG 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2009-08-20 |
| Est. Completion | 2019-04-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00978250
The ClinicalTrials.gov registry entry for NCT00978250 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU) is the first listed.
NCT00978250 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00978250 about?
NCT00978250 is a clinical study titled "A Multi-Histology Phase II Study of 5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine (FdCyd + THU)". Background: * Two experimental drugs, FdCyd (also called 5-fluoro-2'-deoxcytidine), and THU (also called tetrahydrouridine), are undergoing trials to test their effectiveness in treating cancer that has not responded to standard therapies. FdCyd is thought to work by changing how genes work in canc...
What is the current status of trial NCT00978250?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2009-08-20. Estimated completion is 2019-04-11.
What interventions are being tested in trial NCT00978250?
The interventions under investigation include: 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU) (DRUG).
Who is sponsoring clinical trial NCT00978250?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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