Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK0683-070 | |||
| 2008_515 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval in patients with relapsed or refractory advanced cancer.
Merck Duration of Treatment : vorinostat; treatment will continue until disease progression or intolerable toxicity is reached
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Arm A: Drug/Placebo |
|
| B | Experimental | Arm B: Placebo/Drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vorinostat | Drug | A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat 800 mg capsules (Period 1) crossing over to Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1) crossing over to Single dose of vorinostat 800 mg capsules (Period 2). Part 2: All patients will receive 400 mg vorinostat capsules once daily. Treatment will continue until disease progression or intolerable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in QTcF at 0.5 Hours | The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value. | Baseline and 0.5 hours |
| Change From Baseline in QTcF at 1 Hour | Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value. | Baseline and 1 hour |
| Change From Baseline in QTcF at 2 Hours | The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value. | Baseline and 2 hours |
| Change From Baseline in QTcF at 3 Hours | The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value. | Baseline and 3 hours |
| Change From Baseline in QTcF at 4 Hours | The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The placebo-corrected change from baseline in QTcF was calculated by subtracting the QTcF change from baseline for placebo at each timepoint from the QTcF change from baseline for vorinostat at each timepoint. | Baseline and 4 hours |
Not provided
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 |
|---|---|---|---|
| 19887475 | Result | Munster PN, Rubin EH, Van Belle S, Friedman E, Patterson JK, Van Dyck K, Li X, Comisar W, Chodakewitz JA, Wagner JA, Iwamoto M. A single supratherapeutic dose of vorinostat does not prolong the QTc interval in patients with advanced cancer. Clin Cancer Res. 2009 Nov 15;15(22):7077-84. doi: 10.1158/1078-0432.CCR-09-1214. Epub 2009 Nov 3. |
Not provided
Not provided
Enrolled patients were assigned to 1 of 2 dose sequences (vorinostat then placebo or placebo then vorinostat) in Part 1 of the study to determine the effect of vorinostat on the QTcF (Fridericia-corrected QT) interval. Following Part 1, active patients continued into Part 2, daily dosing of vorinostat.
Eric Rubin, M.D., The Cancer Institute of New Jersey, New Brunswick, New Jersey; Pamela Munster, M.D., H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida; Prof. Dr. Simon van Belle, University Hospital of Ghent, Ghent, Belgium.
Dosing initiated on 16-Jul-2007 and completed on 05-Feb-2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vorinostat Then Placebo: Part 1 | Single dose 800 mg vorinostat in Period 1 followed by a three day wash out period, then matching placebo in Period 2. Following the last dose of study drug, there was a minimum 5 day washout before entering Part 2. |
| FG001 | Placebo Then Vorinostat: Part 1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1, Period 1 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Comparator: placebo (unspecified) | Drug | A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1). |
|
| Change From Baseline in QTcF at 8 Hours | The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value. | Baseline and 8 hours |
| Change From Baseline in QTcF at 12 Hours | The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value. | Baseline and 12 hours |
| Change From Baseline in QTcF at 24 Hours | The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value. | Baseline and 24 hours |
Single dose matching placebo in Period 1 followed by a three day wash out period, then single dose 800 mg vorinostat in Period 2. Following the last dose of study drug, there was a minimum 5 day washout before entering Part 2. |
| FG002 | All Participants: Part 2 | Vorinostat 400 mg once daily. Ten participants changed dosage to vorinostat 300 mg daily during Part 2. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part 1, Washout |
|
| Part 1, Period 2 |
|
| Post-Part 1 Washout |
|
| Part 2 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All Participants group includes data from all participants throughout Part 1 and Part 2 of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Cancer Type | Number | Participants |
| |||||||||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG Scale: 0 = Normal Activity, 1 = Symptoms, but ambulatory, 2 = In bed <50% of the time, 3 = In bed >50% of the time, 4 = 100% Bedridden, 5 = Dead | Number | Participants |
| ||||||||||||||||||||||
| Number of Prior Radiation Therapies | Number | Participants |
| |||||||||||||||||||||||
| Number of Prior Systemic Anti-Cancer Therapies | Number | 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 | Change From Baseline in QTcF at 0.5 Hours | The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value. | All patients as treated population in Part 1 of the Study; 22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded) | Posted | Mean | 95% Confidence Interval | milliseconds | Baseline and 0.5 hours |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in QTcF at 1 Hour | Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value. | All patients as treated population in Part 1 of the Study; 22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded) | Posted | Mean | 95% Confidence Interval | milliseconds | Baseline and 1 hour |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in QTcF at 2 Hours | The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value. | All patients as treated population in Part 1 of the Study; 22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded) | Posted | Mean | 95% Confidence Interval | milliseconds | Baseline and 2 hours |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in QTcF at 3 Hours | The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value. | All patients as treated population in Part 1 of the Study; 22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded) | Posted | Mean | 95% Confidence Interval | milliseconds | Baseline and 3 hours |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in QTcF at 4 Hours | The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The placebo-corrected change from baseline in QTcF was calculated by subtracting the QTcF change from baseline for placebo at each timepoint from the QTcF change from baseline for vorinostat at each timepoint. | All patients as treated population in Part 1 of the Study; 22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded) | Posted | Mean | 95% Confidence Interval | milliseconds | Baseline and 4 hours |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in QTcF at 8 Hours | The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value. | All patients as treated population in Part 1 of the Study; 22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded) | Posted | Mean | 95% Confidence Interval | milliseconds | Baseline and 8 hours |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in QTcF at 12 Hours | The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value. | All patients as treated population in Part 1 of the Study; 22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded) | Posted | Mean | 95% Confidence Interval | milliseconds | Baseline and 12 hours |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in QTcF at 24 Hours | The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value. | All patients as treated population in Part 1 of the Study; 22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded) | Posted | Mean | 95% Confidence Interval | milliseconds | Baseline and 24 hours |
|
|
Reported adverse experiences are those from the time patients began study treatment until the patient discontinued. The average AE reporting timeframe is 78 days.
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 | All Participants | All Participants group includes data from all participants throughout Part 1 and Part 2 of the study. | 11 | 25 | 24 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Disease Progression | General disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Pyrexia | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Portal Vein Thrombosis | Hepatobiliary disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Peripheral Embolism | Vascular disorders | MedDRA Version 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Abdominal Cramp | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Abdominal Fullness | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Gas | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Gas Pain | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Gingival Bleeding | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Loose Stools | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Axillary Pain | General disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Early Satiety | General disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Foot Edema | General disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Gait Unsteady | General disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Intermittent Pyrexia | General disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Leg Edema | General disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Edema Lower Limb | General disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Suprapubic Pain | General disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Weakness | General disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Weakness Generalized | General disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Sinus Infection | Infections and infestations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 12.0 | Systematic Assessment |
| |
| Alkaline Phosphatase Increased | Investigations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Blood Carbon Dioxide Increased | Investigations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Blood Creatine Increased | Investigations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Blood Glucose Increased | Investigations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Blood Magnesium Decreased | Investigations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Blood Magnesium Increased | Investigations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Blood Potassium Decreased | Investigations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Electrocardiogram QT Corrected Interval Prolonged | Investigations | MedDRA Version 12.0 | Systematic Assessment |
| |
| International Normalized Ratio Increased | Investigations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Neutrophil Count Increased | Investigations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Prothrombin Time Prolonged | Investigations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Skin Turgor Decreased | Investigations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 12.0 | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA Version 12.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Hyperchloremia | Metabolism and nutrition disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Hypercreatininemia | Metabolism and nutrition disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Hyperphosphatasemia | Metabolism and nutrition disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Foot Cramps | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Low Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Pain In Hip | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Pain In Leg | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Shoulder Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Unilateral Leg Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Dysphasia | Nervous system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Neuropathic Pain | Nervous system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Numbness | Nervous system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Numbness In Toes | Nervous system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Taste Changed | Nervous system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Tingling | Nervous system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Tingling Feet/Hands | Nervous system disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Bladder Discomfort | Renal and urinary disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Renal Insufficiency | Renal and urinary disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Urine Discoloration | Renal and urinary disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Benign Prostatic Hypertrophy | Reproductive system and breast disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Breast Pain | Reproductive system and breast disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Spotting Vaginal | Reproductive system and breast disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Vaginal Pain | Reproductive system and breast disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Dry Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Dyspnea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 12.0 | Systematic Assessment |
| |
| Inferior Venacaval Thrombosis | Vascular disorders | MedDRA Version 12.0 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | clinicaltrialsdisclosure@merck.com |
| ID | Term |
|---|---|
| D000077337 | Vorinostat |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
Not provided
Not provided
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Hispanic |
|
| White |
|
| Lung |
|
| Mesothelioma |
|
| Uterine |
|
| Soft Tissue |
|
| Anal |
|
| Basocellular |
|
| Breast |
|
| Gastrointestinal |
|
| Mucinous carcinoma |
|
| Pancreatic |
|
| Thyroid |
|
| 2 = In bed <50% of the time |
|
| Two Prior Radiation Therapies |
|
| Three or More Prior Radiation Therapies |
|
| Three or more Prior Systemic Anti-Cancer Therapies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|