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NCT01034163 · ClinicalTrials.gov registry record · Phase 3
A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma (HL)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 41
- Enrollment target
NCT01034163 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 41 participants.
The verdict
NCT01034163, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 41 participants
- Enrollment target
Study Summary
The primary objective was to provide drug to ongoing patients who were receiving panobinostat and to characterize the safety and tolerability of panobinostat in patients with HL after achieving a complete response following autologous hematopoietic stem cell transplant (AHSCT) with high dose chemotherapy (HDT). Primary objective as stated above reflects a change from the original protocol as of an amendment. The original objective was no longer feasible with only 41 of 367 patients randomized after the study was halted due to poor recruitment. An amendment was written to allow patients on panobinostat to continue their treatment until discontinuation/completion criteria were met (patients were unblinded). Therefore, the study was completed as per this amendment. No secondary objectives were included for this trial from the amendment; this was a change from the original protocol.
Interventions
- DRUG Placebo
- DRUG Panobinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2010-06 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01034163
The ClinicalTrials.gov registry entry for NCT01034163 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01034163 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01034163 about?
NCT01034163 is a clinical study titled "A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma (HL)". The primary objective was to provide drug to ongoing patients who were receiving panobinostat and to characterize the safety and tolerability of panobinostat in patients with HL after achieving a complete response following autologous hematopoietic stem cell transplant (AHSCT) with high dose chemoth...
What is the current status of trial NCT01034163?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 41 participants. The study started on 2010-06. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01034163?
The interventions under investigation include: Placebo (DRUG), Panobinostat (DRUG).
Who is sponsoring clinical trial NCT01034163?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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