Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK0683-016 | |||
| 2005_019 |
Not provided
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The study was stopped due to low enrollment.
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This is an investigational study that increases the dosage to determine the safety/tolerability, and efficacy of a histone deacetylase inhibitor in combination with Targretin in patients with cutaneous T-cell lymphoma in patients who have failed at least one prior systemic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week |
|
| Cohort 2 | Experimental | Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week |
|
| Cohort 2a | Experimental | Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week |
|
| Cohort 2b | Experimental | Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week |
|
| Cohort 6 | Experimental | Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vorinostat | Drug | Dose escalation study starting with vorinostat 200 mg q.d. capsules (1 capsule daily) and rising up to vorinostat 400 mg q.d. capsules (1 capsule daily). Up to 6 months of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities | Number of patients with Dose Limiting Toxicities (DLT). A DLT is an adverse event that determined the treatment dose level was not tolerable for that patient in Cycle 1. | Day 1 to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Responded to Treatment | Disease burden as assessed by the pre-specified Severity Weighted Assessment Tool (SWAT) measurement. A Response is defined as equal to or greater than 50% improvement in SWAT score. SWAT Score is determined by the Lesions classified as patch, plaque, or tumor. The sum of percent of total body surface area (%TBSA) by lesion type is derived and multiplied by a factor of 1 (for patch), 2 (for plaque), or 4 (for tumor). The skin score total is derived by summing the skin score subtotals for patches, plaques and tumors. The skin score total is dimensionless and can range from 0 to 400 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22239668 | Result | Dummer R, Beyer M, Hymes K, Epping MT, Bernards R, Steinhoff M, Sterry W, Kerl H, Heath K, Ahern JD, Hardwick JS, Garcia-Vargas J, Baumann K, Rizvi S, Frankel SR, Whittaker SJ, Assaf C. Vorinostat combined with bexarotene for treatment of cutaneous T-cell lymphoma: in vitro and phase I clinical evidence supporting augmentation of retinoic acid receptor/retinoid X receptor activation by histone deacetylase inhibition. Leuk Lymphoma. 2012 Aug;53(8):1501-8. doi: 10.3109/10428194.2012.656625. Epub 2012 Feb 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week |
| FG001 | Cohort 2 | Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week |
| FG002 | Cohort 2a | Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week |
| FG003 | Cohort 2b | Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week |
| FG004 | Cohort 6 | Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week |
| FG005 | Cohort 7 | Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)] |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Base Protocol |
|
| ||||||||||||||||||
| Continuation Phase |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week |
| BG001 | Cohort 2 | Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities | Number of patients with Dose Limiting Toxicities (DLT). A DLT is an adverse event that determined the treatment dose level was not tolerable for that patient in Cycle 1. | All Patients treated | Posted | Number | Participants | Day 1 to day 28 |
|
Not provided
Not provided
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 | Cohort 1 | Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
Study was discontinued due to low enrollment
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077337 | Vorinostat |
| D000077610 | Bexarotene |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cohort 7 | Experimental | Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)](streamdown:incomplete-link) |
|
|
| Comparator: bexarotene | Drug | Dose escalation with bexarotene 150 mg/m2 capsules rising up to 300 mg/m2 capsules (1 capsule daily). Up to 6 months of treatment. |
|
|
| Every 28 days for up to 6 Months of Treatment |
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Cohort 2a | Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week |
| BG003 | Cohort 2b | Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week |
| BG004 | Cohort 6 | Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week |
| BG005 | Cohort 7 | Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)] |
| BG006 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity | Number | participants |
|
| OG002 | Cohort 2a | Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week |
| OG003 | Cohort 2b | Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week |
| OG004 | Cohort 6 | Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week |
| OG005 | Cohort 7 | Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)] |
|
|
| Secondary | Number of Participants Who Responded to Treatment | Disease burden as assessed by the pre-specified Severity Weighted Assessment Tool (SWAT) measurement. A Response is defined as equal to or greater than 50% improvement in SWAT score. SWAT Score is determined by the Lesions classified as patch, plaque, or tumor. The sum of percent of total body surface area (%TBSA) by lesion type is derived and multiplied by a factor of 1 (for patch), 2 (for plaque), or 4 (for tumor). The skin score total is derived by summing the skin score subtotals for patches, plaques and tumors. The skin score total is dimensionless and can range from 0 to 400 | All patients treated | Posted | Number | Participants | Every 28 days for up to 6 Months of Treatment |
|
|
|
| 2 |
| 3 |
| EG001 | Cohort 2 | Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week | 2 | 5 |
| EG002 | Cohort 2a | Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week | 1 | 3 |
| EG003 | Cohort 2b | Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week | 0 | 3 |
| EG004 | Cohort 6 | Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week | 2 | 5 |
| EG005 | Cohort 7 | Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)] | 1 | 4 |
| Hypersensitivity | Immune system disorders | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Lymph Node Abscess | Infections and infestations | Non-systematic Assessment |
|
| Lymphangitis | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Mycosis Fungoides | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| T-Cell Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Skin Necrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Anaemia Megaloblastic | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hypochromic Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Thrombocythaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Atrioventricular Block First Degree | Cardiac disorders | Non-systematic Assessment |
|
| Atrioventricular Block Second Degree | Cardiac disorders | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Non-systematic Assessment |
|
| Dry Eye | Eye disorders | Non-systematic Assessment |
|
| Eyelid Irritation | Eye disorders | Non-systematic Assessment |
|
| Vitreous Opacities | Eye disorders | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Lip Swelling | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Steatorrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Adverse Drug Reaction | General disorders | Non-systematic Assessment |
|
| Asthenia | General disorders | Non-systematic Assessment |
|
| Chest Discomfort | General disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Feeling Cold | General disorders | Non-systematic Assessment |
|
| Feeling Hot | General disorders | Non-systematic Assessment |
|
| General Physical Health Deterioration | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Peripheral Coldness | General disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Ulcer | General disorders | Non-systematic Assessment |
|
| Abscess Limb | Infections and infestations | Non-systematic Assessment |
|
| Anogenital Warts | Infections and infestations | Non-systematic Assessment |
|
| Conjunctivitis Infective | Infections and infestations | Non-systematic Assessment |
|
| Gingival Infection | Infections and infestations | Non-systematic Assessment |
|
| Influenza | Infections and infestations | Non-systematic Assessment |
|
| Lymph Gland Infection | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Oral Herpes | Infections and infestations | Non-systematic Assessment |
|
| Otitis Externa | Infections and infestations | Non-systematic Assessment |
|
| Puncture Site Infection | Infections and infestations | Non-systematic Assessment |
|
| Skin Infection | Infections and infestations | Non-systematic Assessment |
|
| Staphylococcal Skin Infection | Infections and infestations | Non-systematic Assessment |
|
| Superinfection | Infections and infestations | Non-systematic Assessment |
|
| Tooth Infection | Infections and infestations | Non-systematic Assessment |
|
| Urinary Tract Infection Bacterial | Infections and infestations | Non-systematic Assessment |
|
| Blood Cholesterol Increased | Investigations | Non-systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | Non-systematic Assessment |
|
| Blood Creatinine Increased | Investigations | Non-systematic Assessment |
|
| Blood Potassium Increased | Investigations | Non-systematic Assessment |
|
| Blood Sodium Increased | Investigations | Non-systematic Assessment |
|
| Blood Triglycerides Increased | Investigations | Non-systematic Assessment |
|
| Blood Urea Increased | Investigations | Non-systematic Assessment |
|
| Body Temperature Increased | Investigations | Non-systematic Assessment |
|
| Electrocardiogram QT Prolonged | Investigations | Non-systematic Assessment |
|
| Electrocardiogram ST Segment | Investigations | Non-systematic Assessment |
|
| Electrocardiogram T Wave Inversion | Investigations | Non-systematic Assessment |
|
| High Density Lipoprotein Decreased | Investigations | Non-systematic Assessment |
|
| Thyroxine Free Decreased | Investigations | Non-systematic Assessment |
|
| Tri-Iodothyronine Free Decreased | Investigations | Non-systematic Assessment |
|
| Weight Decreased | Investigations | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Latent Autoimmune Diabetes In Adults | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hypercreatinaemia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Ageusia | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Hypogeusia | Nervous system disorders | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | Non-systematic Assessment |
|
| Mental Impairment | Nervous system disorders | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Peripheral Sensory Neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | Non-systematic Assessment |
|
| Syncope Vasovagal | Nervous system disorders | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Depressed Mood | Psychiatric disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | Non-systematic Assessment |
|
| Sleep Disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Polyuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Lung Infiltration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Alopecia Effluvium | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermatitis Allergic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Night Sweats | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Onychoclasis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin Burning Sensation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin Fissures | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Flushing | Vascular disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| 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 |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| No Response |
|