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| ID | Type | Description | Link |
|---|---|---|---|
| MK0683-064 | |||
| 2007_536 |
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This study is to evaluate the efficacy, safety and tolerability of vorinostat in patients with lower risk Myelodysplastic Syndrome (MDS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | vorinostat 400 mg |
|
| 2 | Experimental | vorinostat 200 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vorinostat | Drug | vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.). Treatment in 21 day cycles for up to 8 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria | Number of responders is defined as the number of patients in the analysis population who have complete response (CR), partial response (PR), or hematologic improvement (HI) per International Working Group Response Criteria during the course of the study. Confirmation of CR or PR will require a second assessment performed 4 weeks or more after the initial assessment. Confirmation of HI will require a second assessment performed 8 weeks or more after the initial assessment. Number of non-responders is defined as the number of patients who did not achieve CR, PR or HI in the study. | 2 Years |
| Safety and Tolerability as Assessed by the Number of Participants With Adverse Events. | Every 21 days while on therapy and at 30 days after the last dose of study therapy |
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Inclusion Criteria:
Patient is a male or female, at least 18 years of age with low or intermediate-1 risk Myelodysplastic Syndrome (MDS) defined by the International Prognostic Scoring System
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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Vorinostat was studied in patients who were first stratified by their International Prognostic Scoring System
for myelodysplastic syndrome (low versus intermediate-1) and than randomized into one of two dose schedules.
Date of first patient in was 26-Jun-2007. The date of last patient last visit for the study was 16-Jul-2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vorinostat Once Daily Dose Schedule | Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle. |
| FG001 | Vorinostat Thrice Daily Dose Schedule | Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| vorinostat | Drug | vorinostat 200 mg by mouth (P.O.) capsules three times daily (t.i.d.). Treatment in 21 day cycles for up to 8 cycles. |
|
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vorinostat Once Daily Dose Schedule | Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle. |
| BG001 | Vorinostat Thrice Daily Dose Schedule | Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Scale 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 |
| |||||||||||||||
| International Prognostic Scoring System Risk (IPSS) | IPSS Risk: Low [Score = 0; Time to Acute myeloid leukemia (AML) (yrs) = 9.4; Median Survival (yrs) = 5.7] IPSS Risk: INT-1 [Score = 0.5 - 1; Time to AML (yrs) = 3.3; Median Survival (yrs) = 3.5] IPSS Risk: INT-2 [Score = 1.5 - 2; Time to AML (yrs) = 1.1; Median Survival (yrs) = 1.2] IPSS Risk: High [Score = >2; Time to AML (yrs) = 0.2; Median Survival (yrs) = 0.4] | Number | Participants |
| |||||||||||||||
| Prior Myelodysplastic Syndromes Therapy | 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 | Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria | Number of responders is defined as the number of patients in the analysis population who have complete response (CR), partial response (PR), or hematologic improvement (HI) per International Working Group Response Criteria during the course of the study. Confirmation of CR or PR will require a second assessment performed 4 weeks or more after the initial assessment. Confirmation of HI will require a second assessment performed 8 weeks or more after the initial assessment. Number of non-responders is defined as the number of patients who did not achieve CR, PR or HI in the study. | Full analysis set (FAS) population is the analysis population. This population consists of all randomized patients who have received at least one dose of study medication. | Posted | Number | Participants | 2 Years |
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| ||||||||||||||||||||||||||||||||||||
| Primary | Safety and Tolerability as Assessed by the Number of Participants With Adverse Events. | Posted | Number | Participants | Every 21 days while on therapy and at 30 days after the last dose of study therapy |
|
|
Serious and non-serious adverse experiences occurring from the time of consent up through 30 days after the last dose of study drug were reported.
One patient was randomized to the Once Daily Dose Schedule, but discontinued before receiving study medication due to a protocol violation and is not included in the safety assessment.
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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 Once Daily Dose Schedule | Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle. | 2 | 9 | 9 | 9 | ||
| EG001 | Vorinostat Thrice Daily Dose Schedule | Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle. | 5 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Splenic haemorrhage | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Left ventricular hypertrophy | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Tongue discolouration | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Cognitive disorder | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Rash | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
This trial was terminated because the pre-specified futility criterion was met.
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 |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D006402 | Hematologic Diseases |
| D001855 | Bone Marrow Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
Not provided
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| 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
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| Male |
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| Black |
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| Asian |
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| 1 = Symptoms, but ambulatory |
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| 2 = In bed < 50% of the time |
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| Intermediate-1 |
|
| No |
|
|