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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005252-41 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panobinostat - 10 to 40 mg/day TIW QoW | Experimental | 10 to 40mg/day TIW QoW (3 times/week every other week) as per parent protocol design |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panobinostat | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline up to approximately 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline up to approximate 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1) | Duarte | California | 91010 3000 | United States | ||
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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There was no screening period. Patients enrolled into trial directly from the parent protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Panobinostat - 10 to 40 mg/Day TIW QoW | 10 to 40mg/day TIW QoW (3 times/week every other week) as per parent protocol design |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 11, 2016 | Nov 18, 2019 |
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| Georgia Regents University SC-2 |
| Augusta |
| Georgia |
| 30912 |
| United States |
| Dana Farber Cancer Institute Reg. Ped | Boston | Massachusetts | 02215 | United States |
| University of Utah / Huntsman Cancer Institute SC-2 | Salt Lake City | Utah | 84103 | United States |
| Novartis Investigative Site | Jerusalem | 91120 | Israel |
| Novartis Investigative Site | Leiden | 2300 RC | Netherlands |
| Novartis Investigative Site | Salamanca | Castille and León | 37007 | Spain |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Panobinostat - 10 to 40 mg/Day TIW QoW | 10 to 40mg/day TIW QoW (3 times/week every other week) as per parent protocol design |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Parent protocol participants | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | Posted | Count of Participants | Participants | baseline up to approximate 5 years |
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| Primary | 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 | Posted | Number | participants | Baseline up to approximately 60 months |
|
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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
AE additional description
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Panobinostat - 10 to 40 mg/Day TIW QoW | 10 to 40mg/day TIW QoW (3 times/week every other week) as per parent protocol design | 0 | 8 | 2 | 8 | 4 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
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| Gastric disorder | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (21.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA (21.0) | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
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| Benign muscle neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 888-669-6682 | Novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 14, 2016 | Nov 18, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077767 | Panobinostat |
| ID | Term |
|---|---|
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| CLBH589E2214 |
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| CLBH589X2105 |
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