Phase I Trial of 4'-Thio-2'-Deoxycytidine (TdCyd) in Patients With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Neoplasms, Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT02423057
- Run by
- National Cancer Institute (NCI)
- People needed
- 27
- Starts
- 2015-05-18
- Expected to finish
- 2025-07-21
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Patients who are receiving any other investigational agents.
- Pregnant women and women who are breastfeeding are excluded from this study.
- Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to active or uncontrolled infection, immune deficiencies, known HIV infection requiring protease inhibitor therapy, Hepatitis B, Hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for greater than or equal to 1 month after treatment of the brain metastases. Patients should not be on anti-seizure medications. These patients may be enrolled at the discretion of the Principal Investigator.
- Malabsorption syndrome or other conditions that would interfere with intestinal absorption.
- INCLUSION OF WOMEN AND MINORITIES:
- Both men and women of all races and ethnic groups are eligible for this trial.
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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