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NCT00976248 · ClinicalTrials.gov registry record · Phase 2
Everolimus (RAD001) in Primary Therapy of Waldenstrom's Macroglobulinemia
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
NCT00976248: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT00976248 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 33 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00976248, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine the safety of RAD001(Everolimus) and the highest dose of this drug that can be given to people safely. RAD001(Everolimus) is a drug that works by preventing cells in the body from growing and dividing. Information from basic and Phase I clinical research studies suggests that RAD001 also may help to prevent tumor growth in people with relapsed or refractory lymphoma.
Primary Outcome
Overall Response = Complete Response + Near Complete Response + Very Good Partial Response + Partial Response + Minor Response Complete Response: resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. A near CR (nCR) is defined as fulfilling all CR criteria in the presence of positive immunofixation test for an IgM paraprotein. Very Good Partial Response: \> 90% reduction i
Interventions
- DRUG RAD001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2009-11 |
| Est. Completion | 2018-07 |
| Phase | Phase 2 |
What the finished NCT00976248 record still lists
NCT00976248 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which RAD001 is the first listed.
NCT00976248 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00976248 about?
NCT00976248 is a clinical study titled "Everolimus (RAD001) in Primary Therapy of Waldenstrom's Macroglobulinemia". The purpose of this research study is to determine the safety of RAD001(Everolimus) and the highest dose of this drug that can be given to people safely. RAD001(Everolimus) is a drug that works by preventing cells in the body from growing and dividing. Information from basic and Phase I clinical res...
What is the current status of trial NCT00976248?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2009-11. Estimated completion is 2018-07.
What interventions are being tested in trial NCT00976248?
The interventions under investigation include: RAD001 (DRUG).
Who is sponsoring clinical trial NCT00976248?
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 NCT00976248's enrollment target sits among peer trials
33 1553rd of 2000 higher than 438 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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