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NCT00969722 · ClinicalTrials.gov registry record · Phase 2
A Study of MAb-3F8 Plus Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Versus 13-cis-Retinoic Acid (RA) Plus GM-CSF in Primary Refractory Neuroblastoma Patients
A Phase 2 study, sponsored by United Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT00969722 is a Phase 2 study that was terminated before completion, run by United Therapeutics. The registered enrollment target is 1 participants.
The verdict
NCT00969722, a Phase 2 study, was terminated before completion, sponsored by United Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, controlled, open-label study. Patients meeting inclusion/exclusion criteria will be randomized (1:1) to receive two cycles of MAb-3F8 plus GM-CSF or RA plus GM-CSF. Patients who do not respond to their assigned treatment after two cycles may cross-over to receive the alternate treatment. Disease response and safety will be assessed in all patients after cycle 2 and after cycle 4.
Interventions
- BIOLOGICAL MAb-3F8
- BIOLOGICAL Subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
- BIOLOGICAL 13-cis-Retinoic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2009-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00969722
The ClinicalTrials.gov registry entry for NCT00969722 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United Therapeutics, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which MAb-3F8 is the first listed.
NCT00969722 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00969722 about?
NCT00969722 is a clinical study titled "A Study of MAb-3F8 Plus Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Versus 13-cis-Retinoic Acid (RA) Plus GM-CSF in Primary Refractory Neuroblastoma Patients". This is a multicenter, randomized, controlled, open-label study. Patients meeting inclusion/exclusion criteria will be randomized (1:1) to receive two cycles of MAb-3F8 plus GM-CSF or RA plus GM-CSF. Patients who do not respond to their assigned treatment after two cycles may cross-over to receive t...
What is the current status of trial NCT00969722?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2009-08.
What interventions are being tested in trial NCT00969722?
The interventions under investigation include: MAb-3F8 (BIOLOGICAL), Subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) (BIOLOGICAL), 13-cis-Retinoic Acid (BIOLOGICAL).
Who is sponsoring clinical trial NCT00969722?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
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