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NCT00493129 · ClinicalTrials.gov registry record · Phase 2
Ontak (Denileukin Diftitox) in Patients With Systemic Mastocytosis (SM)
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT00493129: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00493129 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00493129, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
Primary Objective: 1\. To assess the response rate of ONTAK in Systemic Mastocytosis (SM) patients. Secondary Objectives: 1. To assess the safety of ONTAK in SM patients. 2. To evaluate the time to progression and duration of response following treatment with ONTAK.
Primary Outcome
Bone marrow samples used to look at response to therapy collected every 3 months until disease progression or different therapy started. Clinical efficacy assessed as objective response (major and partial response) for responding patients analyzed by the Kaplan-Meier method.
Interventions
- DRUG Ontak (Denileukin Diftitox)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2004-07 |
| Est. Completion | 2007-08 |
| Phase | Phase 2 |
What the finished NCT00493129 record still lists
NCT00493129 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Ontak (Denileukin Diftitox) is the first listed.
NCT00493129 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00493129 about?
NCT00493129 is a clinical study titled "Ontak (Denileukin Diftitox) in Patients With Systemic Mastocytosis (SM)". Primary Objective: 1\. To assess the response rate of ONTAK in Systemic Mastocytosis (SM) patients. Secondary Objectives: 1. To assess the safety of ONTAK in SM patients. 2. To evaluate the time to progression and duration of response following treatment with ONTAK.
What is the current status of trial NCT00493129?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2004-07. Estimated completion is 2007-08.
What interventions are being tested in trial NCT00493129?
The interventions under investigation include: Ontak (Denileukin Diftitox) (DRUG).
Who is sponsoring clinical trial NCT00493129?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00493129's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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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