Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01534598 · ClinicalTrials.gov registry record · Phase 1
FdCyd and THU for Advanced Solid Tumors
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
NCT01534598: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01534598 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 59 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01534598, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
Study Summary
Background: \- FdCyd (also called 5-fluoro-2'-deoxycytidine) and THU (also called tetrahydrouridine) are experimental cancer treatment drugs. FdCyd may change how genes work in cancer cells. THU helps keep FdCyd from being broken down by the body. FdCyd and THU have been given to people on other cancer treatment trials, usually by vein. Researchers want to give FdCyd and THU by mouth to see if they work against cancers that have not responded to earlier treatments. Objectives: \- To test oral FdCyd and THU on advanced solid tumors that have not responded to earlier treatments. Eligibility: \- Individuals at least 18 years of age who have advanced solid tumors that have not responded to standard treatments. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and tumor samples will used to study the cancer before treatment. * FdCyd and THU will be given in 21-day cycles. THU should be taken 30 minutes before taking FdCyd. * Participants will take FdCyd and THU by mouth, once a day, for 3 days at the beginning of the first and second weeks of each cycle (days 1 3 and 8 10). The drugs will not be taken during the entire third week of each cycle. * Treatment will be monitored with frequent blood tests and imaging studies. * Treatment will continue as long as the cancer is responding to the drugs and serious side effects do not develop.
Interventions
- DRUG FdCyd + THU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2012-03-05 |
| Est. Completion | 2025-07-21 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01534598
The ClinicalTrials.gov registry entry for NCT01534598 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 59 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 FdCyd + THU is the first listed.
NCT01534598 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01534598 about?
NCT01534598 is a clinical study titled "FdCyd and THU for Advanced Solid Tumors". Background: \- FdCyd (also called 5-fluoro-2'-deoxycytidine) and THU (also called tetrahydrouridine) are experimental cancer treatment drugs. FdCyd may change how genes work in cancer cells. THU helps keep FdCyd from being broken down by the body. FdCyd and THU have been given to people on other ca...
What is the current status of trial NCT01534598?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2012-03-05. Estimated completion is 2025-07-21.
What interventions are being tested in trial NCT01534598?
The interventions under investigation include: FdCyd + THU (DRUG).
Who is sponsoring clinical trial NCT01534598?
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
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.