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NCT01752426 · ClinicalTrials.gov registry record · Phase 1
Pilot Study to Determine Effects of the Btk Inhibitor PCI-32765 on Leukemia Cell Kinetics and Trafficking, Using Heavy Water Labeling in Subjects With CLL and SLL
A Phase 1 study of Leukemia, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01752426: Completed Phase 1 study of Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT01752426 is a Phase 1 study of Leukemia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 30 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01752426, a Phase 1 study of Leukemia, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to learn how PCI-32765 (ibrutinib) may affect the life cycle of blood-cancer cells. Cancer cells will be "labeled" with heavy water to learn about their birth rates and death rates. Ibrutinib is a type of drug called a kinase inhibitor. Kinases are proteins inside cells that help cells live and grow. The study drug is designed to inhibit or "block" the activity of a type of kinase that helps blood-cancer cells live and grow. By blocking the activity of this specific kinase, it is possible that the study drug may kill the cancer cells or stop them from growing. Heavy water (2H2O) is a special type of water that is designed to help researchers learn how quickly cancer cells in the body reproduce.
Primary Outcome
Stable isotopic labeling with deuterated water (2\^H2O) to measure directly the effects of PCI-32765 (ibrutinib) on leukemia cell death in the peripheral blood of participants .
Conditions Studied
Interventions
- DRUG PCI-32765
- OTHER Heavy Water (2H2O)
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-12-17 |
| Est. Completion | 2018-08-09 |
| Phase | Phase 1 |
What the finished NCT01752426 record still lists
NCT01752426 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 2 interventions - of which PCI-32765 is the first listed.
NCT01752426 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01752426 about?
NCT01752426 is a clinical study titled "Pilot Study to Determine Effects of the Btk Inhibitor PCI-32765 on Leukemia Cell Kinetics and Trafficking, Using Heavy Water Labeling in Subjects With CLL and SLL". The goal of this clinical research study is to learn how PCI-32765 (ibrutinib) may affect the life cycle of blood-cancer cells. Cancer cells will be "labeled" with heavy water to learn about their birth rates and death rates. Ibrutinib is a type of drug called a kinase inhibitor. Kinases are protei...
What is the current status of trial NCT01752426?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2012-12-17. Estimated completion is 2018-08-09.
What conditions does trial NCT01752426 study?
This clinical trial studies the following conditions: Leukemia.
What interventions are being tested in trial NCT01752426?
The interventions under investigation include: PCI-32765 (DRUG), Heavy Water (2H2O) (OTHER).
Who is sponsoring clinical trial NCT01752426?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01752426 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01752426's enrollment target sits among peer trials
30 159th of 233 higher than 69 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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