5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors
Status:
Recruiting
Trial end date:
2022-09-30
Target enrollment:
Participant gender:
Summary
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