A Phase 2 interventional study of Panobinostat in Hematologic Neoplasms, sponsored by Novartis Pharmaceuticals. Completed at 7 sites in 4 countries. Per ClinicalTrials.gov, last updated 2019-12-06.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
The study allowed continued use of single agent panobinostat in patients who were on single agent panobinostat treatment in a Novartis-sponsored study which had met its endpoint and were benefiting from the treatment as judged by the investigator.
This was a multi-center open label study to provide continued use of single agent oral panobinostat to patients treated in a Novartis-sponsored study (parent study) which had met its endpoint and were benefiting from continuation of the treatment with single-agent panobinostat as judged by the investigator. Patients from multiple parent studies were transferred over to this protocol and continued to receive single agent panobinostat at the last assigned dose and regimen of the parent protocol. There was no screening period, and patients had to visit the study center at least on a quarterly basis. During these visits limited information on study treatment and occurrence of SAEs was collected for the clinical database. SAEs were only reported to the Novartis safety database. Other assessments and possibly more frequent visits occurred as per standard of care at the site. Patients continued treatment until they were no longer benefiting from panobinostat treatment, developed unacceptable toxicities, withdrew consent, were non-compliant with the protocol, the investigator believed it was no longer in the best interest to continue, the patient died, or for other administrative reasons. An end of treatment visit and a safety follow-up for 30 days after the last dose was performed. The study was expected to remain open for 5 years or until such time that enrolled patients no longer needed treatment with panobinostat, whichever came earlier.
1,463 studies on the registry are indexed under Hematologic Neoplasms; 432 are open to participants now.
This study's enrollment of 9 is below the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
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Exclusion Criteria:
10 to 40mg/day TIW QoW (3 times/week every other week) as per parent protocol design
Drug: Panobinostat
Panobinostat was provided as 5, 10 and 20 mg hard gelatin capsules to be taken orally. Patients started on dose from parent protocol and dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.
Overview of Adverse Events (Safety Set)
Adverse events were collected from baseline up to 30 days post treatment at scheduled visits. Severity of adverse events was assessed according to the current version of Common Terminology Criteria for Adverse Events (CTCAE). If CTCAE grading did not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to Grades 1 - 4, was used
Time frame: Baseline up to approximately 60 months
Percentage of Patients With Clinical Benefit as Assessed by the Investigator.
Patients were assessed by investigators at scheduled visits to determine if patient continued to benefit from panobinostat therapy.
Time frame: baseline up to approximate 5 years
| Milestone | Panobinostat - 10 to 40 mg/Day TIW QoW |
|---|---|
| Started | 8 |
| Completed | 0 |
| Not completed | 8 |
| Withdrew: Administrative problems | 2 |
| Withdrew: Disease progression | 6 |
Patients were assessed by investigators at scheduled visits to determine if patient continued to benefit from panobinostat therapy.
| Participants | Panobinostat - 10 to 40 mg/Day TIW QoW |
|---|---|
| Participants with clinical benefit | 7 |
Adverse events were collected from baseline up to 30 days post treatment at scheduled visits. Severity of adverse events was assessed according to the current version of Common Terminology Criteria for Adverse Events (CTCAE). If CTCAE grading did not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to Grades 1 - 4, was used
| participants | Panobinostat - 10 to 40 mg/Day TIW QoW |
|---|---|
| Any adverse event (AE) | 6 |
| Any treatment related AE | 2 |
| Any serious adverse event (SAE) | 2 |
| Grade 3 or 4 AE | 3 |
| Grade 3 or 4 AE - suspected to be related | 1 |
| AEs leading discontinuation | 0 |
| AEs leading to dose adjust/ temp dose interruption | 2 |
| On-treatment death | 0 |
Collected over Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 84 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Panobinostat - 10 to 40 mg/Day TIW QoW | 0/8 (0%) | 2/8 (25%) | 4/8 (50%) |
| Event | Panobinostat - 10 to 40 mg/Day TIW QoW |
|---|---|
| Non-cardiac chest painGeneral disorders | 1/8 |
| Cerebrovascular accidentNervous system disorders | 1/8 |
| Event | Panobinostat - 10 to 40 mg/Day TIW QoW |
|---|---|
| Neuropathy peripheralNervous system disorders | 2/8 |
| NeutropeniaBlood and lymphatic system disorders | 1/8 |
| DiarrhoeaGastrointestinal disorders | 1/8 |
| Gastric disorderGastrointestinal disorders | 1/8 |
| AstheniaGeneral disorders | 1/8 |
| NasopharyngitisInfections and infestations | 1/8 |
| Blood creatinine increasedInvestigations | 1/8 |
| Platelet count decreasedInvestigations | 1/8 |
| Bone painMusculoskeletal and connective tissue disorders | 1/8 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 1/8 |
| Age, Continuous(years) | Panobinostat - 10 to 40 mg/Day TIW QoW |
|---|---|
| Mean | 54 ± 14.5 |
| Sex: Female, Male(Participants) | Panobinostat - 10 to 40 mg/Day TIW QoW |
|---|---|
| Female | 4 |
| Male | 4 |
| Race and Ethnicity Not Collected(Participants) | Panobinostat - 10 to 40 mg/Day TIW QoW |
|---|
| Parent protocol participants(participants) | Panobinostat - 10 to 40 mg/Day TIW QoW |
|---|---|
| CLBH589B2201 | 2 |
| CLBH589B2207 | 3 |
| CLBH589E2214 | 1 |
| CLBH589X2105 | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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