5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Sep 30, 2026 → Sep 30, 2028
See other at-risk trials from National Cancer Institute (NCI)

Record History

The 50 most recent of 503 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 30, 2026 to Sep 30, 2028
  2. Re-verified, no change to tracked fields
  3. Eligibility criteria shortened, about 9 words
  4. 9 versions Re-verified since Aug 6, 2026, no change to tracked fieldsv492-v500
  5. Enrollment increased: 65 → 75 participantsv491
Show 37 earlier versionsHide 37 earlier versions
  1. 20 versions Re-verified since Jan 21, 2026, no change to tracked fieldsv471-v490
  2. Study Status, Study Description, Eligibilityv470
  3. 16 versions Re-verified since Jul 31, 2025, no change to tracked fieldsv454-v469
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Blood, tissue, and tumor cells contain genes. Genes are made up of DNA. DNA is the "instruction book" for each cell. In some people with cancer, the genes that might have slowed the growth of their tumor were "turned off." Researchers want to see if a new drug can turn the genes back on and slow the tumor growth. The drug is called Aza-TdC. Objective: To test the safety of Aza-TdC, and to find out the dose of this drug that can be safely given to humans. Eligibility: People ages 18 and older who have advanced cancer that has gotten worse after standard treatment, or for which no effective therapy exists Design: Participants will be screened with: Medical history Blood and urine tests Scans to measure their tumors Test to measure the electrical activity of the heart Participants will take the study drug by mouth. The drug is given in cycles. Each cycle is 21 days (3 weeks) long. Week 1 and week 2: participants will take the study drug once a day for 5 days. Then they will have 2 days without the drug. Week 3: no study drug is taken. This completes one cycle of treatment. For cycle 1, participants will repeat the screening tests several times. For all other cycles, participants will have blood tests and pregnancy tests. They will have scans of their tumor every 6 weeks. The cycle will be repeated as long as the participant tolerates the drug and the cancer is either stable or gets better. Sponsoring Institute: National Cancer Institute
Trial Details
NCT Number NCT03366116
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Neoplasms, Solid Tumors
Related terms Neoplasms
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov