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NCT01240577 · ClinicalTrials.gov registry record · Phase 1
An Early Phase I Study of IPdR Absorption, Metabolism, and Safety in Patients With Advanced Solid Tumors and Lymphomas
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01240577: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01240577 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01240577, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study 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.
Interventions
- DRUG IPdR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2010-10-26 |
| Est. Completion | 2012-07-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01240577
The ClinicalTrials.gov registry entry for NCT01240577 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which IPdR is the first listed.
NCT01240577 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01240577 about?
NCT01240577 is a clinical study titled "An Early Phase I Study of IPdR Absorption, Metabolism, and Safety in Patients With Advanced Solid Tumors and Lymphomas". 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...
What is the current status of trial NCT01240577?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2010-10-26. Estimated completion is 2012-07-30.
What interventions are being tested in trial NCT01240577?
The interventions under investigation include: IPdR (DRUG).
Who is sponsoring clinical trial NCT01240577?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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