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NCT01023308 · ClinicalTrials.gov registry record · Phase 3
Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 767
- Enrollment target
NCT01023308 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 767 participants.
The verdict
NCT01023308, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 767 participants
- Enrollment target
Study Summary
Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile. Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.
Interventions
- DRUG Placebo
- DRUG Dexamethasone
- DRUG Bortezomib
- DRUG Panobinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 767 participants |
| Start Date | 2009-12-21 |
| Est. Completion | 2015-07-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01023308
The ClinicalTrials.gov registry entry for NCT01023308 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 767 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 4 interventions - of which Placebo is the first listed.
NCT01023308 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01023308 about?
NCT01023308 is a clinical study titled "Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma". Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with p...
What is the current status of trial NCT01023308?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 767 participants. The study started on 2009-12-21. Estimated completion is 2015-07-30.
What interventions are being tested in trial NCT01023308?
The interventions under investigation include: Placebo (DRUG), Dexamethasone (DRUG), Bortezomib (DRUG), Panobinostat (DRUG).
Who is sponsoring clinical trial NCT01023308?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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