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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_565 |
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Part I evaluates the safety, tolerability and pharmacokinetics (PK) of vorinostat in Japanese patients with relapsed or refractory CTCL. Part II evaluates the safety of vorinostat in Japanese pts. with relapsed or refractory CTCL. Relapsed or refractory CTCL patients will be newly enrolled in Part II.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vorinostat | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vorinostat | Drug | Parts I & II: Vorinostat (400 mg) Oral, daily (QD). Treatment period is 28 days per cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE) | A laboratory AE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A clinical AE is defined similarly but also includes changes in structure or function of the body. | Day 1 up until 30 days post study completion or early termination (up to approximately 506 days) |
| Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT) | A DLT was defined as any of the following (per Common Terminology Criteria for Adverse Events [CTCAE] version 3.0):
| Day 1 to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Part I: Total Drug Exposure (Area Under the Concentration Curve, AUC[0-24 Hours]) | Blood samples taken as follows: Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat. | Days 1 & 28 of Cycle 1 |
| Part I: Maximum Drug Concentration (Cmax) |
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Inclusion Criteria (Parts I & II):
Exclusion Criteria (Parts I & II):
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22506596 | Result | Wada H, Tsuboi R, Kato Y, Sugaya M, Tobinai K, Hamada T, Shimamoto T, Noguchi K, Iwatsuki K. Phase I and pharmacokinetic study of the oral histone deacetylase inhibitor vorinostat in Japanese patients with relapsed or refractory cutaneous T-cell lymphoma. J Dermatol. 2012 Oct;39(10):823-8. doi: 10.1111/j.1346-8138.2012.01554.x. Epub 2012 Apr 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part I | Vorinostat 400 mg oral, daily (QD). Treatment period was 28 days per cycle. |
| FG001 | Part II | Vorinostat 400 mg oral, daily (QD). Treatment period was 28 days per cycle. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vorinostat | Parts I & II: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE) | A laboratory AE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A clinical AE is defined similarly but also includes changes in structure or function of the body. | Posted | Number | participants | Day 1 up until 30 days post study completion or early termination (up to approximately 506 days) |
|
|
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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 | Vorinostat | Parts I & II: vorinostat(400 mg) Oral, daily (QD). Treatment period was 28 days per cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077337 | Vorinostat |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Blood samples taken as follows: Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat. |
| Days 1 & 28 of Cycle 1 |
| Part I: Time at Which Cmax Occurs (Tmax) | Blood samples taken as follows: Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat. | Days 1 & 28 of Cycle 1 |
| Part I: The Amount of Time it Takes for the Drug Concentration to Decrease by Half (T1/2) | Blood samples taken as follows: Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat. | Days 1 & 28 of Cycle 1 |
| Protocol Violation |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Part I: Total Drug Exposure (Area Under the Concentration Curve, AUC[0-24 Hours]) | Blood samples taken as follows: Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat. | Number of participants with samples at the specified time point | Posted | Geometric Mean | Standard Deviation | µM*hr | Days 1 & 28 of Cycle 1 |
|
|
|
| Primary | Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT) | A DLT was defined as any of the following (per Common Terminology Criteria for Adverse Events [CTCAE] version 3.0):
| Posted | Number | participants | Day 1 to Day 28 |
|
|
|
| Secondary | Part I: Maximum Drug Concentration (Cmax) | Blood samples taken as follows: Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat. | Number of participants with samples at the specified time point | Posted | Geometric Mean | Standard Deviation | µM | Days 1 & 28 of Cycle 1 |
|
|
|
| Secondary | Part I: Time at Which Cmax Occurs (Tmax) | Blood samples taken as follows: Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat. | Number of participants with samples at the specified time point | Posted | Median | Full Range | hours | Days 1 & 28 of Cycle 1 |
|
|
|
| Secondary | Part I: The Amount of Time it Takes for the Drug Concentration to Decrease by Half (T1/2) | Blood samples taken as follows: Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat. | Number of participants with samples at the specified time point | Posted | Geometric Mean | Standard Deviation | hours | Days 1 & 28 of Cycle 1 |
|
|
|
| 3 |
| 10 |
| 10 |
| 10 |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cellulitis streptococcal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Erythropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Body tinea | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Keratitis herpetic | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood cholinesterase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood fibrinogen increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Fibrin D dimer increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Prothrombin time shortened | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypercreatinaemia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemoglobinuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |