Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK0683-056 | |||
| 2006_539 |
Not provided
Not provided
Not provided
The study was terminated based on the recommendation by the DSMB following a pre-planned protocol interim analysis because the endpoint was not achieved.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Phase III clinical trial which incorporates an initial Phase II component will determine the survival of advanced Non-small cell lung cancer patients when treated with MK0683 and paclitaxel plus carboplatin
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | vorinostat; IV paclitaxel; IV carboplatin |
|
| 2 | Placebo Comparator | Placebo; IV paclitaxel; IV carboplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vorinostat | Drug | vorinostat 400 mg capsules once daily. Up to 6 months of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Defined as the time from date of randomization to death due to any cause. Patients without documented death at the time of the final analysis will be censored at the date of the last follow-up. | Start of treatment to death |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Disease progression is defined as at least a 20% increase in sum of the longest diameter of all target lesions, the appearance of a new lesion, or an increase in non-target lesions. | Start of treatment to disease progression or death |
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 |
|---|---|---|---|
| 26521238 | Derived | Beaumont H, Souchet S, Labatte JM, Iannessi A, Tolcher AW. Changes of lung tumour volume on CT - prediction of the reliability of assessments. Cancer Imaging. 2015 Oct 31;15:17. doi: 10.1186/s40644-015-0052-2. |
Not provided
Not provided
Randomized participants were stratified by Stage (IIIB versus IV), geographic region and eligibility for treatment with bevacizumab prior to treatment assignment.
This study was conducted at 99 investigative sites worldwide. The first patient's first visit was 16 May 07 and the last patient's last visit was 12 Dec 2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vorinostat + Paclitaxel + Carboplatin | Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Comparator: paclitaxel | Drug | intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment |
|
|
| Comparator: carboplatin | Drug | intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment. |
|
|
| Comparator: placebo | Drug | vorinostat 400 mg placebo capsules once daily. Up to 6 months of treatment |
|
| Number of Participants Who Had a Disease Response to Treatment | Response to treatment is defined as a complete response (CR) or partial response (PR) to treatment. Confirmation of response required a second assessment performed at least 4 weeks after the initial assessment. (PR is defined as at least a 30% reduction in sum of the longest diameter of all target lesions and no increase in non-target lesions). | Every 42 days from start of treatment until disease response |
| FG001 | Placebo + Paclitaxel + Carboplatin | Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vorinostat + Paclitaxel + Carboplatin | Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle. |
| BG001 | Placebo + Paclitaxel + Carboplatin | Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment 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, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||
| Cancer Stage | Number | Participants |
| |||||||||||||||||||
| Eligibility to receive treatment with Bevacizumab | Number | Participants |
| |||||||||||||||||||
| Geographic region where the participant lived | 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 | Overall Survival | Defined as the time from date of randomization to death due to any cause. Patients without documented death at the time of the final analysis will be censored at the date of the last follow-up. | Intention-to-treat (ITT) population is defined as all randomized participants. Participants are counted in the group to which they are randomized. | Posted | Median | Full Range | Months | Start of treatment to death |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival | Defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Disease progression is defined as at least a 20% increase in sum of the longest diameter of all target lesions, the appearance of a new lesion, or an increase in non-target lesions. | Full analysis set (FAS) population defined as all randomized participants who have received at least one dose of study medication. There are 253 participants randomized in the study 5 didn't take any study medication. Therefore, 248 participants are included in this analysis population. | Posted | Median | Full Range | Months | Start of treatment to disease progression or death |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Had a Disease Response to Treatment | Response to treatment is defined as a complete response (CR) or partial response (PR) to treatment. Confirmation of response required a second assessment performed at least 4 weeks after the initial assessment. (PR is defined as at least a 30% reduction in sum of the longest diameter of all target lesions and no increase in non-target lesions). | Full analysis set (FAS) population is defined as all randomized participants who have received at least one dose of study medication. There are 253 participants randomized in the study. Five (5) didn't take any study medication. Therefore, 248 participants are included in this analysis population. | Posted | Number | Participants | Every 42 days from start of treatment until disease response |
|
Adverse Events were collected from the time the patient signed the informed consent form until 30 days after the last dose of study medications. Serious Adverse Events were followed until resolution.
The 5 untreated patients on study are not counted in the Adverse Events tables. Further, one patient was randomized to vorinostat but took placebo; and one patient, randomized to placebo, started vorinostat for 4 days before using placebo. Both patients are counted in the placebo group for Adverse Events, yielding 124 patients in each group.
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 | Vorinostat + Paclitaxel + Carboplatin | Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle. | 63 | 124 | 114 | 124 | ||
| EG001 | Placebo + Paclitaxel + Carboplatin | Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle. | 45 | 124 | 117 | 124 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rectal perforation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Nasopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Aortic thrombosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Superior vena caval occlusion | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
The study was stopped following a pre-planned interim analysis because the goal for this study to continue was not met, based on 100 events, a reduction in the hazard ratio for progression-free survival by > 23% with a one-sided p-value < 0.1
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 |
|---|---|
| D000077337 | Vorinostat |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Male |
|
| Black |
|
| Asian |
|
| American Indian or Alaskan Native mix |
|
| IV |
|
| Ineligible |
|
| Unknown |
|
| Europe (United Kingdom, Italy, Germany, and Spain) |
|
| Asia |
|
| Rest of the World |
|
|
|
|
|
|
|