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| ID | Type | Description | Link |
|---|---|---|---|
| MK0683-048 | |||
| 2006_030 |
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This is a clinical study to evaluate the safety and pharmacokinetics of an overseas determined maximum tolerated dose (MTD) of MK-0683 (vorinostat) in a Japanese patient population with solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vorinostat 600 mg | Experimental | 600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest. |
|
| Vorinostat 400 mg | Experimental | 400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vorinostat | Drug | 600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Dose Limiting Toxicity (DLT) | Dose Limiting Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment | 21 Days (first cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC(0-infinity)) at Day 1 (600 mg and 400 mg) | Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (o- ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). At 600 mg, t=12 hours and at 400 mg, t=24 hours. | Day 1 (600 mg and 400 mg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22234637 | Result | Doi T, Hamaguchi T, Shirao K, Chin K, Hatake K, Noguchi K, Otsuki T, Mehta A, Ohtsu A. Evaluation of safety, pharmacokinetics, and efficacy of vorinostat, a histone deacetylase inhibitor, in the treatment of gastrointestinal (GI) cancer in a phase I clinical trial. Int J Clin Oncol. 2013 Feb;18(1):87-95. doi: 10.1007/s10147-011-0348-6. Epub 2012 Jan 11. |
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Study of 2 doses of vorinostat (MK-0683) in participants with solid tumors who failed standard therapy. >= 3 participants were enrolled at each dose. In the case of a dose level toxicity, a maximum of 6 participants were enrolled per level. If no safety problems, a total of 10 participants were evaluated for pharmacokinetics.
Phase I. First participant started on study therapy on 18-Jul-2006. Study was multicenter (total of 3 sites).
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| ID | Title | Description |
|---|---|---|
| FG000 | Vorinostat 600 mg | 600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days) |
| FG001 | Vorinostat 400 mg | 400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vorinostat 600 mg | 600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days) |
| BG001 | Vorinostat 400 mg | 400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days |
| 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 | Number of Participants With a Dose Limiting Toxicity (DLT) | Dose Limiting Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment | Six (6) participants received vorinostat at 400 mg once daily. Of these, 2 participants did not complete the first cycle resulting in the drug compliance falling below 75%, and thus these participants were excluded from the DLT assessment. | Posted | Number | Participants | 21 Days (first cycle) |
|
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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 600 mg | 600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 9.1 | 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 |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077337 | Vorinostat |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Vorinostat | Drug | 400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days. |
|
|
| Area Under the Curve (AUC(0-infinity)) at Day 3 (600 mg) |
Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 12) plus AUC (12 - ∞) |
| Day 3 (600 mg) |
| Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg) | Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 24) plus AUC (24 - ∞) | Day 21 (400 mg) |
| Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg) | Day 1 (600 mg and 400 mg) |
| Maximum Concentration (Cmax) at Day 3 (600 mg) | Day 3 (600 mg) |
| Maximum Concentration (Cmax) at Day 21 (400 mg) | Day 21 (400 mg) |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Prior chemotherapy regimens | Median | Full Range | Number of prior chemotherapy regimens |
|
400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
|
|
| Secondary | Area Under the Curve (AUC(0-infinity)) at Day 1 (600 mg and 400 mg) | Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (o- ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). At 600 mg, t=12 hours and at 400 mg, t=24 hours. | Six (6) participants received vorinostat at 400 mg once daily. Of these, one (1) participant had missing Pharmacokinetics Data on Day 1 because the participant vomited after administration on Day 1. | Posted | Geometric Mean | Standard Deviation | μM·hr | Day 1 (600 mg and 400 mg) |
|
|
|
| Secondary | Area Under the Curve (AUC(0-infinity)) at Day 3 (600 mg) | Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 12) plus AUC (12 - ∞) | Posted | Geometric Mean | Standard Deviation | μM·hr | Day 3 (600 mg) |
|
|
|
| Secondary | Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg) | Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 24) plus AUC (24 - ∞) | Six (6) participants received vorinostat at 400 mg once daily. Of these, four (4) participants had missing Pharmacokinetics Data on Day 21 because they did not receive study drug on day 21. | Posted | Geometric Mean | Standard Deviation | μM·hr | Day 21 (400 mg) |
|
|
|
| Secondary | Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg) | Six (6) participants received vorinostat at 400 mg once daily. Of these, one (1) participant had missing Pharmacokinetics Data on Day 1 because the participant vomited after administration on Day 1. | Posted | Geometric Mean | Standard Deviation | μM | Day 1 (600 mg and 400 mg) |
|
|
|
| Secondary | Maximum Concentration (Cmax) at Day 3 (600 mg) | Posted | Geometric Mean | Standard Deviation | μM | Day 3 (600 mg) |
|
|
|
| Secondary | Maximum Concentration (Cmax) at Day 21 (400 mg) | Six (6) participants received vorinostat at 400 mg once daily. Of these, four (4) participants had missing Pharmacokinetics Data on Day 21 because they did not receive study drug on day 21. | Posted | Geometric Mean | Standard Deviation | μM | Day 21 (400 mg) |
|
|
|
| 4 |
| 10 |
| 10 |
| 10 |
| EG001 | Vorinostat 400 mg | 400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days | 0 | 6 | 6 | 6 |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| DISEASE PROGRESSION | General disorders | MedDRA 9.1 | Systematic Assessment |
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| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 9.1 | Systematic Assessment |
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| PALPITATIONS | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
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| EAR CONGESTION | Ear and labyrinth disorders | MedDRA 9.1 | Systematic Assessment |
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| EAR DISCOMFORT | Ear and labyrinth disorders | MedDRA 9.1 | Systematic Assessment |
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| TINNITUS | Ear and labyrinth disorders | MedDRA 9.1 | Systematic Assessment |
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| VERTIGO | Ear and labyrinth disorders | MedDRA 9.1 | Systematic Assessment |
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| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| ACETONAEMIC VOMITING | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| ASCITES | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| CHEILITIS | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| DRY MOUTH | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| ERUCTATION | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| GASTRIC HAEMORRHAGE | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| STOMACH DISCOMFORT | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| STOMATITIS | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| CATHETER SITE PAIN | General disorders | MedDRA 9.1 | Systematic Assessment |
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| CHEST DISCOMFORT | General disorders | MedDRA 9.1 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA 9.1 | Systematic Assessment |
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| CHILLS | General disorders | MedDRA 9.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 9.1 | Systematic Assessment |
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| FEELING ABNORMAL | General disorders | MedDRA 9.1 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| OEDEMA | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| PAIN | General disorders | MedDRA 9.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 9.1 | Systematic Assessment |
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| THIRST | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| CHOLANGITIS | Hepatobiliary disorders | MedDRA 9.1 | Systematic Assessment |
|
| PYELONEPHRITIS | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
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| ACTIVATED PARTIAL THROMBOPLASTIN TIME SHORTENED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| BLOOD ALBUMIN DECREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| BLOOD CALCIUM DECREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| BLOOD CHLORIDE DECREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| BLOOD GLUCOSE DECREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| BLOOD MAGNESIUM DECREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| BLOOD MAGNESIUM INCREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| BLOOD PHOSPHORUS DECREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| BLOOD PHOSPHORUS INCREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| BLOOD POTASSIUM INCREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
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| BLOOD SODIUM DECREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
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| BLOOD URIC ACID DECREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| ELECTROCARDIOGRAM QT PROLONGED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
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| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| PLATELET COUNT DECREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| PROTEIN TOTAL DECREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| PROTEIN URINE PRESENT | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| RED BLOOD CELLS URINE POSITIVE | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| URINARY SEDIMENT ABNORMAL | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| URINE BILIRUBIN INCREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| UROBILIN URINE PRESENT | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| WHITE BLOOD CELL COUNT INCREASED | Investigations | MedDRA 9.1 | Systematic Assessment |
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| WHITE BLOOD CELLS URINE | Investigations | MedDRA 9.1 | Systematic Assessment |
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| ANOREXIA | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
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| HYPERMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| DYSGEUSIA | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| EXTRAPYRAMIDAL DISORDER | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| PYRAMIDAL TRACT SYNDROME | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
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| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
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| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| NAIL BED INFLAMMATION | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| HAEMORRHAGE | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 9.1 | 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.
| D000588 |
| Amines |
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |