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NCT01614821 · ClinicalTrials.gov registry record · Phase 2
Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT01614821: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT01614821 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01614821, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug, PCI-32765, to learn whether PCI-32765 works in treating a specific cancer. "Investigational" means that PCI-32765 is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if PCI-32765 is effective for treating different types of cancer. It also means that the FDA has not yet approved PCI-32765 for use in patients, including people with Waldenstrom's Macroglobulinemia. PCI-32765 is a newly discovered drug that is being developed as an anti-cancer agent. PCI-32765 is a Bruton's tyrosine kinase (Btk) inhibitor drug which interrupts B cell receptor (BCR) signaling in lymphomas by selectively and irreversibly binding to the Btk protein, which then results in malignant cell death. This drug has been used in laboratory experiments and other research studies in B-cell malignancies and information from those other research studies suggests that PCI-32765 may be a treatment strategy for B-cell malignancies, including Waldenstrom's Macroglobulinemia. In this research study, the investigators are testing the safety and efficacy of PCI-32765 as a treatment option for relapsed or refractory Waldenstrom's Macroglobulinemia.
Primary Outcome
To assess the overall response rate (\>25% reduction in serum IgM from baseline).
Interventions
- DRUG PCI-32765
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2012-05 |
| Est. Completion | 2018-09-15 |
| Phase | Phase 2 |
What the finished NCT01614821 record still lists
NCT01614821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which PCI-32765 is the first listed.
NCT01614821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01614821 about?
NCT01614821 is a clinical study titled "Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia". This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug, PCI-32765, to learn whether PCI-32765 works in treating a specific cancer. "Investigational" means that PCI-32765 is still being studied and that research doctors are trying ...
What is the current status of trial NCT01614821?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2012-05. Estimated completion is 2018-09-15.
What interventions are being tested in trial NCT01614821?
The interventions under investigation include: PCI-32765 (DRUG).
Who is sponsoring clinical trial NCT01614821?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01614821's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 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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