An Early Phase I Study of IPdR Absorption, Metabolism, and Safety in Patients With Advanced Solid Tumors and Lymphomas
Status:
Completed
Trial end date:
2012-07-30
Target enrollment:
Participant gender:
Summary
Background:
- The experimental drug IPdR is broken down in the body to IdUrd, which has been given to
patients to find out if it can improve radiation therapy. IdUrd has to be given through a
vein; therefore this new drug (IPdR) has been made which can be taken by mouth. Researchers
are interested in determining whether IPdR should also be studied to find out if it can
improve radiation therapy. The current study is to find out if people absorb the drug given
by mouth.
Objectives:
- To evaluate the levels of drug and its breakdown products in the blood following a single
dose of IPdR by mouth. .
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with cancer (solid tumors or
lymphomas) that have not responded to standard treatment.
Design:
- This study involves an initial dosing visit, one day of admission to the hospital for
blood work, and a follow-up visit 14 days later.
- Participants will be screened with a physical examination and medical history, as well
as blood and urine samples.
- Participants will receive a single dose of IPdR, and will provide multiple blood and
urine samples for 24 hours after administration of the drug.
- Fourteen days after receiving IPdR, participants will have another physical examination
and additional blood and urine tests to evaluate how IPdR has been broken down by the
body.
- Cancer treatment will not be provided as part of this protocol.