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| ID | Type | Description | Link |
|---|---|---|---|
| MK0683-025 | Other Identifier | Merck | |
| 2005_080 | Other Identifier | Merck |
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This trial is being closed based on lack of substantive efficacy, slow accrual and overall tolerance in patients treated to date.
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The reason for this study will be to find the safest maximum tolerated dose of oral vorinostat in combination with erlotinib [Tarceva (TM)] that can be given to patients with lung cancer who have relapsed or failed other therapy for the disease. Once the safest maximum tolerated dose of vorinostat is determined, patients enrolled in the clinical trial will continue vorinostat and erlotinib for up to 8 months. Safety and effectiveness will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk | Experimental | Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion |
|
| Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk | Experimental | Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study. |
|
| Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk | Experimental | Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study. |
|
| Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk | Experimental | Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vorinostat | Drug | Vorinostat 200 mg twice a day for 3 days a week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) Occurring in Cycle 1 of the Phase I Portion of the Study | Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase I portion of the study. | Day 1 to 28 in the Phase I portion of the study |
| Dose Limiting Toxicity Occurring in Cycle 1 of the Phase II Portion of the Study | Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase II portion of the study. | Day 1 to 28 in the Phase II portion of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Unconfirmed Partial Response (UPR) Based on Response Criteria in Solid Tumors (RECIST) | An unconfirmed partial response is defined as a partial response that has not been confirmed by a follow up CT scan (or MRI) at least 4 weeks after the criteria for response are first met. (A partial response is defined as an at least 30% reduction in the sum of the longest diameter of the target lesions. Non-target lesions must be at least stable) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
Enrolled patients were assigned to 1 of 2 dose escalating cohorts (A and B) in the Phase I portion of the study to determine the maximum tolerated dose (MTD). Once determined, new patients were assigned to the Phase II portion of the study and treated with the MTD. Active Phase I patients continued into Phase II.
This study was conducted at 12 investigative sites in the United States. The first patient's first visit was 30 March 2006. The study was terminated early on 12 Oct 2007 and the last patient's last visit was 30 Oct 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
| Vorinostat | Drug | Vorinostat 300 mg once a day for 3 days a week. |
|
|
| Vorinostat | Drug | Vorinostat 300 mg twice a day for 3 days a week. |
|
|
| Vorinostat | Drug | Vorinostat 400 mg once a day for 21 out of 28 days. |
|
|
| erlotinib | Drug | erlotinib 150 mg once a day. |
|
|
| Every 57 days beginning with Cycle 3, or more frequently if appropriate |
| Stable Disease (SD) as Best Response Based on Response Criteria in Solid Tumors (RECIST) | Stable disease is defined as less than a radiographic partial response, but not progressive disease | Every 57 days beginning with Cycle 3, or more frequently if appropriate |
| Progressive Disease (PD) as Best Response Based on Response Criteria in Solid Tumors (RECIST) | Progressive disease is defined as a ≥20% increase in the sum of the longest diameter, the appearance of one or more new lesions and/or unequivocal progression of non-target lesions by conventional or spiral CT or MRI | Every 57 days beginning with Cycle 3, or more frequently if appropriate |
| Disease Progression After Week 8 Based on Response Criteria in Solid Tumors (RECIST) | First documentation of Progressive Disease (PD) occurring > 8 weeks on study. | Every 57 days beginning with Cycle 3 (Week 8), or more frequently if appropriate |
| Progression-free Survival | Progression-free survival was measured from the start of the treatment to the time when the criteria for progression was met or death due to any cause (whichever is first recorded). | Day 1 to disease progression or death |
| FG001 | Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study. |
| FG002 | Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study. |
| FG003 | Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion. |
| BG001 | Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study. |
| BG002 | Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study. |
| BG003 | Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study. |
| BG004 | 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 |
| |||||||||||||||
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Dose Limiting Toxicity (DLT) Occurring in Cycle 1 of the Phase I Portion of the Study | Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase I portion of the study. | All patients as treated population in Cycle 1 of the Phase I portion of the study. | Posted | Number | Participants | Day 1 to 28 in the Phase I portion of the study |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Unconfirmed Partial Response (UPR) Based on Response Criteria in Solid Tumors (RECIST) | An unconfirmed partial response is defined as a partial response that has not been confirmed by a follow up CT scan (or MRI) at least 4 weeks after the criteria for response are first met. (A partial response is defined as an at least 30% reduction in the sum of the longest diameter of the target lesions. Non-target lesions must be at least stable) | All patients as treated population with post-baseline data available to determine Unconfirmed Partial Response as Best Response. | Posted | Number | Participants | Every 57 days beginning with Cycle 3, or more frequently if appropriate |
| |||||||||||||||||||||||||||||||||||||
| Primary | Dose Limiting Toxicity Occurring in Cycle 1 of the Phase II Portion of the Study | Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase II portion of the study. | All patients as treated population in Cycle 1 of the Phase II portion of the study. | Posted | Number | Participants | Day 1 to 28 in the Phase II portion of the study |
| |||||||||||||||||||||||||||||||||||||
| Post-Hoc | Dose Limiting Toxicity Occurring in Cycles 2 and Beyond of the Phase II Portion of the Study | Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycles 2 and beyond of the Phase II portion of the study. | All patients as treated population in Cycles 2 and beyond of the Phase II portion of the study. | Posted | Number | Participants | After day 28 in the Phase II portion of the study |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Stable Disease (SD) as Best Response Based on Response Criteria in Solid Tumors (RECIST) | Stable disease is defined as less than a radiographic partial response, but not progressive disease | All patients treated population with post-baseline data available to determine Stable Disease as Best Response. | Posted | Number | Participants | Every 57 days beginning with Cycle 3, or more frequently if appropriate |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Progressive Disease (PD) as Best Response Based on Response Criteria in Solid Tumors (RECIST) | Progressive disease is defined as a ≥20% increase in the sum of the longest diameter, the appearance of one or more new lesions and/or unequivocal progression of non-target lesions by conventional or spiral CT or MRI | All patients as treated population with post-baseline data available to determine Progressive Disease as Best Response. | Posted | Number | Participants | Every 57 days beginning with Cycle 3, or more frequently if appropriate |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Disease Progression After Week 8 Based on Response Criteria in Solid Tumors (RECIST) | First documentation of Progressive Disease (PD) occurring > 8 weeks on study. | All patients as treated population with post-baseline data available to determine Disease Progression After Week 8. | Posted | Number | Participants | Every 57 days beginning with Cycle 3 (Week 8), or more frequently if appropriate |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression-free survival was measured from the start of the treatment to the time when the criteria for progression was met or death due to any cause (whichever is first recorded). | All patients as treated population with post-baseline data available to determine progression free survival. Cohort A, Dose Level 1 (Amended), Cohort B, Dose Level 2 and Cohort A, Dose Level 1 (Original) are not represented in the below table as post-baseline data were not available to determine progression free survival. | Posted | Mean | Full Range | Days | Day 1 to disease progression or death |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion. | 6 | 16 | 16 | 16 | ||
| EG001 | Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study. | 2 | 3 | 3 | 3 | ||
| EG002 | Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study. | 2 | 2 | 2 | 2 | ||
| EG003 | Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study. | 1 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Pneumococcal bacteraemia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Eyelids pruritus | Eye disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Keratoconjunctivitis sicca | Eye disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Breath odour | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Rectal fissure | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Perineal pain | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
Due to the slow pace of patient accrual, failure to observe meaningful efficacy in treated patients, and overall intolerance of the combination regimen, the study was terminated prematurely on 12-Oct-2007.
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 |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077337 | Vorinostat |
| D000069347 | Erlotinib Hydrochloride |
| 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 |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| > 65 years |
|
| Male |
|
| OG002 | Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study. |
| OG003 | Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study. |
|
|
Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
| OG003 | Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study. |
|
|
Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
| OG003 | Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study. |
|
|
Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
| OG003 | Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study. |
|
|
Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study. |
| OG003 | Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study. |
|
|
Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
| OG003 | Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk | Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study. |
|
|
|