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NCT01109069 · ClinicalTrials.gov registry record · Phase 2
Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia
A Phase 2 study, sponsored by Pharmacyclics.
- Completed
- Registry status
- Phase 2
- Development phase
- 199
- Enrollment target
NCT01109069: Completed Phase 2 study, sponsored by Pharmacyclics.
NCT01109069 is a Phase 2 study that has completed, run by Pharmacyclics. The registered enrollment target is 199 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01109069, a Phase 2 study, has completed, sponsored by Pharmacyclics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 199 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the long-term safety of a fixed-dose, daily regimen of PCI-32765 PO in subjects with B cell lymphoma or chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL).
Primary Outcome
Subjects were to receive ibrutinib once daily at the dose level the subject was receiving in the parent study until disease progression or unacceptable toxicity. The study included Screening, Treatment (from the first dose until study drug discontinuation), and Follow-up Phases.
Interventions
- DRUG PCI-32765
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2010-06 |
| Est. Completion | 2019-04-26 |
| Phase | Phase 2 |
What the finished NCT01109069 record still lists
NCT01109069 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 1 intervention - of which PCI-32765 is the first listed.
NCT01109069 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01109069 about?
NCT01109069 is a clinical study titled "Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia". The purpose of this study is to determine the long-term safety of a fixed-dose, daily regimen of PCI-32765 PO in subjects with B cell lymphoma or chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL).
What is the current status of trial NCT01109069?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 199 participants. The study started on 2010-06. Estimated completion is 2019-04-26.
What interventions are being tested in trial NCT01109069?
The interventions under investigation include: PCI-32765 (DRUG).
Who is sponsoring clinical trial NCT01109069?
This trial is sponsored by Pharmacyclics, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01109069's enrollment target sits among peer trials
199 349th of 2000 higher than 1,652 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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