An Early Phase I Study of IPdR Absorption, Metabolism, and Safety in Patients With Advanced Solid Tumors and Lymphomas

Completed · Phase 1

Conditions studied: Neoplasms, Lymphoma

In brief

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.

Key facts

Study ID

NCT01240577

Run by

National Cancer Institute (NCI)

People needed

10

Starts

2010-10-26

Expected to finish

2012-07-30

Last updated by the study team

2018-10-18

Who can join

Age: 18 and older, up to 110. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients may not be receiving any other investigational agents.
• Uncontrolled intercurrent illness including, but not limited to, ongoing uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, GI conditions limiting absorption, serious skin conditions, or psychiatric illness/social situations that would limit compliance with study requirements.
• Women who are pregnant or nursing.
• INCLUSION OF WOMEN AND MINORITIES:
• Both men and women and members of all races and ethnic groups are eligible for this trial.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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