Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment was stopped on 15 June 2009 (early termination date) due to low prevalence of study population and slow accrual.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluated the safety and efficacy of LBH589B in adult participants with refractory/resistant Cutaneous T-Cell Lymphoma and prior Histone Deacetylase (HDAC) inhibitor therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panobinostat 20 mg | Experimental | Participants received panobinostat, 20 milligrams (mg), capsules, orally, thrice weekly on alternate Days 1, 3, and 5 per week of a 28-day treatment cycle until unacceptable toxicity, disease progression, and/or physician's discretion to discontinue the treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panobinostat | Drug | Panobinostat, 20 mg, hard gelatin capsules, orally, thrice weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) in Participants With Resistant Cutaneous T-Cell Lymphoma (CTCL) Treated With Oral Panobinostat by Using the Modified Severity-Weighted Assessment Tool (mSWAT) | ORR was defined as the percentage of participants with best overall response (OR) of complete response (CR) or partial response (PR) based on mSWAT score, (OR = CR + PR). mSWAT score represents the product of the percentage total body surface area (%TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor: modified SWAT score = (patch %TBSA x 1) + (plaque %TBSA x 2) + (tumor or ulcer %TBSA x 4). The sum of these 3 numbers gave the modified SWAT score, on a 0 (no lesions) to 400 (lesions covering all areas) scale. CR based on mSWAT score was defined as the absence of skin disease. PR was defined as ≥ 50% decrease of the modified SWAT score compared to the Baseline score. | From first dose of study drug up to disease progression or death, (up to approximately 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate of Participants With Refractory CTCL Using the Physician's Global Assessment of Clinical Condition (PGA) | Response rate was defined as the percentage of participants with CR or PR based on PGA scale. PGA is a 7-point grading scale for the investigator's assessment of the overall extent of improvement or worsening of the participant's disease as compared to Baseline. CR corresponds to Grade 0 (Completely clear) on PGA scale and was defined as no evidence of disease; 100% improvement. PR corresponds to Grade 2 (marked improvement) on PGA scale and was defined as significant improvement (≥75% - <90%); some evidence of disease remains. |
Not provided
Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham/ The Kirklin Clinic | Birmingham | Alabama | 35233 | United States | ||
Not provided
A total of 9 participants were enrolled in the study at 8 investigative sites in the USA from 5 July 2007 to 15 June 2009. Recruitment was stopped on 15 June 2009 (early termination date) due to low prevalence of study population and slow accrual.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Panobinostat 20 mg | Participants received panobinostat, 20 mg, capsules, orally, thrice weekly on alternate Days 1, 3 and 5 per week of a 28-day treatment cycle until unacceptable toxicity, disease progression and/or physician's discretion to discontinue the treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| From first dose of study drug up to disease progression or death, (up to approximately 2 years) |
| Response Rate in Participants With Refractory CTCL Using Modified Skin Score | Response rate was defined as the percentage of participants with CR or PR based on mSWAT skin score. mSWAT score represents the product of the %TBSA involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor: mSWAT score = (patch %TBSA x 1) + (plaque %TBSA x 2) + (tumor or ulcer %TBSA x 4). The sum of these 3 numbers gave the modified SWAT score, on a 0 (no lesions) to 400 (lesions covering all areas) scale. CR based on mSWAT score was defined as the absence of skin disease. PR was defined as ≥ 50% decrease of the modified SWAT score compared to the Baseline score. | From first dose of study drug up to disease progression or death, (up to approximately 2 years) |
| Responses in Index Lesions in Participants With Refractory CTCL by Lesion Measurements With Photographic Supporting Documentation | Index lesions in each participant were selected as four to six of the prominent lesions amenable to bi-dimensional measurements. The longest diameter and its perpendicular measurement were used to determine the surface area and a weighted sum was determined as: Lesion 1 + lesion 2 + … + lesions 6 = Total sum of weighted score where Lesion 1: cm^2 x [1 (for patch); 2 (for plaque); 4 (for tumor or ulcer)]; Lesion 2: cm^2 x [1 (for patch); 2 (for plaque); 4 (for tumor or ulcer)]; Lesion 6: cm^2 x [1 (for patch); 2 (for plaque); 4 (for tumor or ulcer)]. These lesions were photographed at Baseline and at the time of response determined by either mSWAT or PGA | From first dose of study drug up to disease progression or death (up to approximately 2 years) |
| ORR of Participants With Resistant CTCL Treated With Oral Panobinostat by Using the Modified PGA to Assess Skin Disease and the Evaluation of Disease in the Viscera, Lymph Nodes and Blood (Circulating Sézary Syndrome Cells) | ORR was defined as the percentage of participants with best OR of CR or PR based on PGA scale (OR = CR + PR). The PGA is a 7-point grading scale for the investigator's assessment of the overall extent of improvement or worsening of the participant's disease as compared to Baseline. CR corresponds to Grade 0 (completely clear) of PGA scale and was defined as no evidence of disease; 100% improvement. PR corresponds to Grade 2 (marked improvement) of PGA scale and was defined as significant improvement (≥75%-<90%); some evidence of disease remains. | From first dose of study drug up to disease progression or death, (up to approximately 2 years) |
| Duration of Response (DOR) | DOR was defined as the time from first documented evidence of CR or PR until the earliest date of documented progression or death due to any cause among participants who achieved a confirmed CR or PR. The DOR was calculated in two ways. The DOR among responders only included participants who responded to the drug. The overall DOR included non-responders as having a DOR of zero days. | From first dose of study drug up to disease progression or death, (up to approximately 2 years) |
| Time to Response (TTR) | TTR was defined as the time from the start of treatment until the first documented evidence of CR or PR among participants who achieved a confirmed CR or PR. | From first dose of study drug up to study completion (approximately 2 years) |
| Progression-Free Survival (PFS) | PFS was defined as the time from the start of treatment until the earliest date of disease progression or death due to any cause, if sooner. | From first dose of study drug up to disease progression or death, (up to approximately 2 years) |
| UCLA Medical Center School of Medicine/ Dpt of Hematology-Oncology |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of Colorado Health Sciences Center/Anschutz Cancer Pavillion | Aurora | Colorado | 80010 | United States |
| Florida Academic Dermatology Centers | Miami | Florida | 33136 | United States |
| Medical College of Georgia | Augusta | Georgia | 30912 | United States |
| Rush Presbyterian Hospital/St. Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| St. Louis University Cancer Cennter | St Louis | Missouri | 63110 | United States |
| Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| NYU Clinical Cancer Center | New York | New York | 10016 | United States |
| Our Lady of Mercy Medical Center/Comprehensive Cancer Center | The Bronx | New York | 10466 | United States |
| Wake University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| University of Oklahoma-Tulsa | Tulsa | Oklahoma | 74104 | United States |
| Craig Okada | Portland | Oregon | 97239 | United States |
| University of Pittsburg Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| The Jones Clinic | Germantown | Tennessee | 38138 | United States |
| MD Anderson Cancer Center/University of Texas | Houston | Texas | 77030 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109-102 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analyses Set (FAS) population was defined according to the Intention-to-Treat (ITT) principle and included all participants enrolled into the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Panobinostat 20 mg | Participants received panobinostat, 20 mg, capsules, orally, thrice weekly on alternate Days 1, 3 and 5 per week of a 28-day treatment cycle until unacceptable toxicity, disease progression and/or physician's discretion to discontinue the treatment. |
| 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 |
|
| 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) in Participants With Resistant Cutaneous T-Cell Lymphoma (CTCL) Treated With Oral Panobinostat by Using the Modified Severity-Weighted Assessment Tool (mSWAT) | ORR was defined as the percentage of participants with best overall response (OR) of complete response (CR) or partial response (PR) based on mSWAT score, (OR = CR + PR). mSWAT score represents the product of the percentage total body surface area (%TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor: modified SWAT score = (patch %TBSA x 1) + (plaque %TBSA x 2) + (tumor or ulcer %TBSA x 4). The sum of these 3 numbers gave the modified SWAT score, on a 0 (no lesions) to 400 (lesions covering all areas) scale. CR based on mSWAT score was defined as the absence of skin disease. PR was defined as ≥ 50% decrease of the modified SWAT score compared to the Baseline score. | Since the study was terminated early due to low prevalence of study population and slow accrual Since the study was terminated early due to low accrual, no analyses were conducted for this study. | Posted | From first dose of study drug up to disease progression or death, (up to approximately 2 years) |
|
| |||||||||||||||||||
| Secondary | Response Rate of Participants With Refractory CTCL Using the Physician's Global Assessment of Clinical Condition (PGA) | Response rate was defined as the percentage of participants with CR or PR based on PGA scale. PGA is a 7-point grading scale for the investigator's assessment of the overall extent of improvement or worsening of the participant's disease as compared to Baseline. CR corresponds to Grade 0 (Completely clear) on PGA scale and was defined as no evidence of disease; 100% improvement. PR corresponds to Grade 2 (marked improvement) on PGA scale and was defined as significant improvement (≥75% - <90%); some evidence of disease remains. | Since the study was terminated early due to low prevalence of study population and slow accrual Since the study was terminated early due to low accrual, no analyses were conducted for this study. | Posted | From first dose of study drug up to disease progression or death, (up to approximately 2 years) |
|
| |||||||||||||||||||
| Secondary | Response Rate in Participants With Refractory CTCL Using Modified Skin Score | Response rate was defined as the percentage of participants with CR or PR based on mSWAT skin score. mSWAT score represents the product of the %TBSA involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor: mSWAT score = (patch %TBSA x 1) + (plaque %TBSA x 2) + (tumor or ulcer %TBSA x 4). The sum of these 3 numbers gave the modified SWAT score, on a 0 (no lesions) to 400 (lesions covering all areas) scale. CR based on mSWAT score was defined as the absence of skin disease. PR was defined as ≥ 50% decrease of the modified SWAT score compared to the Baseline score. | Since the study was terminated early due to low prevalence of study population and slow accrual Since the study was terminated early due to low accrual, no analyses were conducted for this study. | Posted | From first dose of study drug up to disease progression or death, (up to approximately 2 years) |
|
| |||||||||||||||||||
| Secondary | Responses in Index Lesions in Participants With Refractory CTCL by Lesion Measurements With Photographic Supporting Documentation | Index lesions in each participant were selected as four to six of the prominent lesions amenable to bi-dimensional measurements. The longest diameter and its perpendicular measurement were used to determine the surface area and a weighted sum was determined as: Lesion 1 + lesion 2 + … + lesions 6 = Total sum of weighted score where Lesion 1: cm^2 x [1 (for patch); 2 (for plaque); 4 (for tumor or ulcer)]; Lesion 2: cm^2 x [1 (for patch); 2 (for plaque); 4 (for tumor or ulcer)]; Lesion 6: cm^2 x [1 (for patch); 2 (for plaque); 4 (for tumor or ulcer)]. These lesions were photographed at Baseline and at the time of response determined by either mSWAT or PGA | Since the study was terminated early due to low prevalence of study population and slow accrual Since the study was terminated early due to low accrual, no analyses were conducted for this study. | Posted | From first dose of study drug up to disease progression or death (up to approximately 2 years) |
|
| |||||||||||||||||||
| Secondary | ORR of Participants With Resistant CTCL Treated With Oral Panobinostat by Using the Modified PGA to Assess Skin Disease and the Evaluation of Disease in the Viscera, Lymph Nodes and Blood (Circulating Sézary Syndrome Cells) | ORR was defined as the percentage of participants with best OR of CR or PR based on PGA scale (OR = CR + PR). The PGA is a 7-point grading scale for the investigator's assessment of the overall extent of improvement or worsening of the participant's disease as compared to Baseline. CR corresponds to Grade 0 (completely clear) of PGA scale and was defined as no evidence of disease; 100% improvement. PR corresponds to Grade 2 (marked improvement) of PGA scale and was defined as significant improvement (≥75%-<90%); some evidence of disease remains. | Since the study was terminated early due to low prevalence of study population and slow accrual Since the study was terminated early due to low accrual, no analyses were conducted for this study. | Posted | From first dose of study drug up to disease progression or death, (up to approximately 2 years) |
|
| |||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR was defined as the time from first documented evidence of CR or PR until the earliest date of documented progression or death due to any cause among participants who achieved a confirmed CR or PR. The DOR was calculated in two ways. The DOR among responders only included participants who responded to the drug. The overall DOR included non-responders as having a DOR of zero days. | Since the study was terminated early due to low prevalence of study population and slow accrual Since the study was terminated early due to low accrual, no analyses were conducted for this study. | Posted | From first dose of study drug up to disease progression or death, (up to approximately 2 years) |
|
| |||||||||||||||||||
| Secondary | Time to Response (TTR) | TTR was defined as the time from the start of treatment until the first documented evidence of CR or PR among participants who achieved a confirmed CR or PR. | Since the study was terminated early due to low prevalence of study population and slow accrual Since the study was terminated early due to low accrual, no analyses were conducted for this study. | Posted | From first dose of study drug up to study completion (approximately 2 years) |
|
| |||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | PFS was defined as the time from the start of treatment until the earliest date of disease progression or death due to any cause, if sooner. | Since the study was terminated early due to low prevalence of study population and slow accrual Since the study was terminated early due to low accrual, no analyses were conducted for this study. | Posted | From first dose of study drug up to disease progression or death, (up to approximately 2 years) |
|
|
Adverse event (AE): From the first dose of study drug up to 28 days after the last dose of study drug (up to approximately 2 years); Serious Adverse Event (SAE): From the first dose of study drug up to 4 weeks after the last dose of study drug (up to approximately 2 years)
Safety population included all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Panobinostat 20 mg | Participants received panobinostat, 20 mg, capsules, orally, thrice weekly on alternate Days 1, 3 and 5 per week of a 28-day treatment cycle until unacceptable toxicity, disease progression and/or physician's discretion to discontinue the treatment. | 1 | 9 | 4 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Ear pruritus | Ear and labyrinth disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Postoperative fever | Injury, poisoning and procedural complications | MedDRA (unspecified) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (unspecified) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (unspecified) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (unspecified) | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA (unspecified) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (unspecified) | Systematic Assessment |
| |
| Lymph node palpable | Investigations | MedDRA (unspecified) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (unspecified) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Lymphorrhoea | Vascular disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
|
The study was terminated early due to low accrual, no formal efficacy analyses were conducted for this study.
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 (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided
| Participants |
|
|