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NCT02423057 · ClinicalTrials.gov registry record · Phase 1
Phase I Trial of 4'-Thio-2'-Deoxycytidine (TdCyd) in Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT02423057: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT02423057 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 27 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02423057, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
Background: \- Genes are made up of DNA and are the instruction book for cells. When people have cancer, some of the genes that might have slowed the growth of tumor cells were turned off. Researchers think a drug called TdCyd might help to turn these genes back on. This may slow the growth of tumors in people with cancer. Objectives: \- To test the safety of TdCyd and to find out how it works. Also, to find out the dose of the drug that can be safely given to humans. Eligibility: \- Adults 18 years and older who have advanced cancer that has progressed after standard treatment, or for which no effective therapy exists. Design: * Participants will take TdCyd by mouth. The drug is given in 21-day cycles. TdCyd is taken once a day during week 1 for 5 days. Then for 2 days participants do not take the drug. Then they take it for 5 days during week 2. No TdCyd is taken during week 3. * Participants will keep a diary of their study drug doses. * Participants will have tests about every 3 weeks to see how the study drugs are affecting their body. They will have blood and urine tests, a medical history, and physical exams. They may have computed tomography (CT) scans to measure their tumors. They may have an electrocardiogram, which measures the heart electrical activity. * If participants develop any side effects, they may be asked to visit more often. * Participants will stay in the study as long as they are tolerating TdCyd and their tumors are either stable or getting better. One month after stopping the drug, they will have a follow-up phone call.
Interventions
- DRUG TdCyd
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2015-05-18 |
| Est. Completion | 2025-07-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02423057
The ClinicalTrials.gov registry entry for NCT02423057 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 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 TdCyd is the first listed.
NCT02423057 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02423057 about?
NCT02423057 is a clinical study titled "Phase I Trial of 4'-Thio-2'-Deoxycytidine (TdCyd) in Patients With Advanced Solid Tumors". Background: \- Genes are made up of DNA and are the instruction book for cells. When people have cancer, some of the genes that might have slowed the growth of tumor cells were turned off. Researchers think a drug called TdCyd might help to turn these genes back on. This may slow the growth of tumo...
What is the current status of trial NCT02423057?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2015-05-18. Estimated completion is 2025-07-21.
What interventions are being tested in trial NCT02423057?
The interventions under investigation include: TdCyd (DRUG).
Who is sponsoring clinical trial NCT02423057?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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