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NCT00398710 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Perifosine in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia
A Phase 2 study, sponsored by AEterna Zentaris.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT00398710: Completed Phase 2 study, sponsored by AEterna Zentaris.
NCT00398710 is a Phase 2 study that has completed, run by AEterna Zentaris. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00398710, a Phase 2 study, has completed, sponsored by AEterna Zentaris.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
This is a phase II study in relapsed/refractory WM patients treated with perifosine. It is designed to assess the proportion of overall confirmed responses (CR + PR + MR) using a two-stage phase II study design to permit early stopping of the trial if there is strong evidence that the study regimen is inactive. In addition, it will assess toxicity of this drug in patients with WM. Patients will receive perifosine 150 mg qhs daily. Patients will be assessed by serum immunoelectrophoresis and IgM level at least every 4 weeks.
Primary Outcome
Response will include complete remission, partial remission (PR), and minimal response (MR) using serum protein electrophoresis. Response will also be assessed by IgM using nephelometry.
Interventions
- DRUG Perifosine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2006-10 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
What the finished NCT00398710 record still lists
NCT00398710 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Perifosine is the first listed.
NCT00398710 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00398710 about?
NCT00398710 is a clinical study titled "A Phase II Study of Perifosine in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia". This is a phase II study in relapsed/refractory WM patients treated with perifosine. It is designed to assess the proportion of overall confirmed responses (CR + PR + MR) using a two-stage phase II study design to permit early stopping of the trial if there is strong evidence that the study regimen ...
What is the current status of trial NCT00398710?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2006-10. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00398710?
The interventions under investigation include: Perifosine (DRUG).
Who is sponsoring clinical trial NCT00398710?
This trial is sponsored by AEterna Zentaris, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00398710's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 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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