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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_040 | |||
| MK-0683-029 | Other Identifier | Merck |
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The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral suberoylanilide hydroxamic acid in participants with solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vorinostat 100 mg | Experimental | During Cycle 1, participants receive a single oral dose of vorinostat 100 mg on Day 1 in a fasted state, Day 3 in a fed state, and Day 19 in a fed state. On Days 5-18, participants receive vorinostat 100 mg twice daily, in the morning and evening. If participants do not match to the discontinuation criteria, they can continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle will be 26 days.) |
|
| Vorinostat 200 mg | Experimental | During Cycle 1, participants receive a single oral dose of vorinostat 200 mg on Day 1 in a fasted state; on Day 3 in a fed state; and on Day 19 in a fed state. On Days 5-18, participants receive vorinostat 200 mg twice daily, in the morning and evening. If participants do not match to the discontinuation criteria, they can continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle will be 26 days.) |
|
| Vorinostat 400 mg | Experimental | During Cycle 1, participants receive a single oral dose of vorinostat 400 mg on Day 1 in a fasted state; on Day 3 in a fed state; and on Day 19 in a fed state. On Days 5-18, participants receive a single oral dose of vorinostat 400 mg once-daily in the morning. If participants do not match to the discontinuation criteria, they can continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle will be 26 days.) |
|
| Vorinostat 500 mg | Experimental | During Cycle 1, participants receive a single oral dose of vorinostat 500 mg on Day 1 in a fasted state; on Day 3 in a fed state; and on Day 19 in a fed state. On Days 5-18, participants receive a single oral dose of vorinostat 500 mg once-daily in the morning. If participants do not match to the discontinuation criteria, they can continue the same dose level therapy on the Cycle 2 and subsequent cycles.(Each cycle will be 26 days.) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vorinostat | Drug | vorinostat 100 mg, 200 mg, 400 mg, or 500 mg single oral dose; once-daily or twice-daily administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced One or More Adverse Events | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 4 years |
| Number of Participants Who Discontinued Study Treatment Due to an Adverse Event | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 4 years |
| Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1 | A DLT was defined as an event considered to be related to study treatment and included: 1) Grade 4 neutropenia refractory to treatments persisting more than 5 days; 2) Grade 3 or more severe neutropenic fever; 3) Grade 3 thrombocytopenia requiring blood transfusions or Grade 4 thrombocytopenia; 4) Grade 4 hemoglobin decrease; 5) Grade 3 or more severe non-hematological toxicities other than anorexia, nausea/vomiting, and fatigue. (For the diarrhea, it was defined as not to use the frequency for the grading. For the alanine aminotransferase [ALT]/aspartate aminotransferase [AST]), it was defined as the case of over 300 IU/L; 6) Grade 3 or more severe anorexia, nausea/vomiting, and fatigue refractory to treatments; and 7) compliance of the study drug, while administrating 14 consecutive days, was less than 50% due to the drug-related adverse experience. | Up to 26 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Time Curve From Hour 0 to Infinity (AUC0-inf) of Vorinostat After a Single Oral Dose in a Fasted State | AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. | Day 1: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
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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 |
|---|---|---|---|
| 19575752 | Background | Fujiwara Y, Yamamoto N, Yamada Y, Yamada K, Otsuki T, Kanazu S, Iwasa T, Hardwick JS, Tamura T. Phase I and pharmacokinetic study of vorinostat (suberoylanilide hydroxamic acid) in Japanese patients with solid tumors. Cancer Sci. 2009 Sep;100(9):1728-34. doi: 10.1111/j.1349-7006.2009.01237.x. Epub 2009 May 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vorinostat 100 mg | During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.) |
| FG001 | Vorinostat 200 mg | During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.) |
| FG002 | Vorinostat 400 mg | During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.) |
| FG003 | Vorinostat 500 mg | During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles.(Each cycle was 26 days.) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vorinostat 100 mg | During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 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 Who Experienced One or More Adverse Events | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | All participants who received at least one dose of study drug. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.) | Posted | Count of Participants | Participants | Up to approximately 4 years |
|
Up to approximately 4 years
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study treatment. All-Cause Mortality: All participants included in a treatment group at enrollment, regardless of treatment duration. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.)
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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 100 mg | During Cycle 1, participants received a single oral dose of vorinostat 100 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 100 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 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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|
|
| AUC0-Inf of Vorinostat After a Single Oral Dose in a Fed State | AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. | Day 3: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
| AUC0-inf of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration | AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. | Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
| Maximum Concentration (Cmax) of Vorinostat After a Single Oral Dose in a Fasted State | Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. | Day 1: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
| Cmax of Vorinostat After a Single Oral Dose in a Fed State | Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. | Day 3: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
| Cmax of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration | Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. | Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
| Time to Maximum Concentration (Tmax) of Vorinostat After a Single Oral Dose in a Fasted State | Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. | Day 1: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
| Tmax of Vorinostat After a Single Oral Dose in a Fed State | Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. | Day 3: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
| Tmax of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration | Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. | Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
| Apparent Terminal Half-Life (t½) of Vorinostat After a Single Oral Dose in a Fasted State | t½ is the elimination half-life of study drug. t½ is the time it takes for half of the study drug in the blood plasma to dissipate. | Day 1: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
| t½ of Vorinostat After a Single Oral Dose in a Fed State | t½ is the elimination half-life of study drug. t½ is the time it takes for half of the study drug in the blood plasma to dissipate. | Day 3: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
| t½ of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration | t½ is the elimination half-life of study drug. t½ is the time it takes for half of the study drug in the blood plasma to dissipate. | Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
| Lack of Efficacy |
|
| BG001 | Vorinostat 200 mg | During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.) |
| BG002 | Vorinostat 400 mg | During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.) |
| BG003 | Vorinostat 500 mg | During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles.(Each cycle was 26 days.) |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Vorinostat 200 mg | During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.) |
| OG002 | Vorinostat 400 mg | During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.) |
| OG003 | Vorinostat 500 mg | During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.) |
|
|
| Primary | Number of Participants Who Discontinued Study Treatment Due to an Adverse Event | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | All participants who received at least one dose of study drug. (Note: 1 participant in 200 mg treatment group had dose reduced to 100 mg in Cycle 8 and is also included in 100 mg treatment group for adverse events.) | Posted | Count of Participants | Participants | Up to approximately 4 years |
|
|
|
| Primary | Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1 | A DLT was defined as an event considered to be related to study treatment and included: 1) Grade 4 neutropenia refractory to treatments persisting more than 5 days; 2) Grade 3 or more severe neutropenic fever; 3) Grade 3 thrombocytopenia requiring blood transfusions or Grade 4 thrombocytopenia; 4) Grade 4 hemoglobin decrease; 5) Grade 3 or more severe non-hematological toxicities other than anorexia, nausea/vomiting, and fatigue. (For the diarrhea, it was defined as not to use the frequency for the grading. For the alanine aminotransferase [ALT]/aspartate aminotransferase [AST]), it was defined as the case of over 300 IU/L; 6) Grade 3 or more severe anorexia, nausea/vomiting, and fatigue refractory to treatments; and 7) compliance of the study drug, while administrating 14 consecutive days, was less than 50% due to the drug-related adverse experience. | All participants who received at least one dose of study drug | Posted | Count of Participants | Participants | Up to 26 days |
|
|
|
| Secondary | Area Under the Plasma Concentration Time Curve From Hour 0 to Infinity (AUC0-inf) of Vorinostat After a Single Oral Dose in a Fasted State | AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. | All participants who complied with the protocol and had Day 1 pharmacokinetic (PK) data for AUC0-inf. | Posted | Geometric Mean | Standard Deviation | μM·hours | Day 1: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
|
|
|
| Secondary | AUC0-Inf of Vorinostat After a Single Oral Dose in a Fed State | AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. | All participants who complied with the protocol and had Day 3 PK data for AUC0-inf. | Posted | Geometric Mean | Standard Deviation | μM·hours | Day 3: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
|
|
|
| Secondary | AUC0-inf of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration | AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. | All participants who complied with the protocol and had up to Day 19 PK data for AUC0-inf | Posted | Geometric Mean | Standard Deviation | μM·hours | Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
|
|
|
| Secondary | Maximum Concentration (Cmax) of Vorinostat After a Single Oral Dose in a Fasted State | Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. | All participants who complied with the protocol and had Day 1 PK data for Cmax | Posted | Geometric Mean | Standard Deviation | μM | Day 1: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
|
|
|
| Secondary | Cmax of Vorinostat After a Single Oral Dose in a Fed State | Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. | All participants who complied with the protocol and had Day 3 PK data for Cmax | Posted | Geometric Mean | Standard Deviation | μM | Day 3: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
|
|
|
| Secondary | Cmax of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration | Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. | All participants who complied with the protocol and had up to Day 19 PK data for Cmax | Posted | Geometric Mean | Standard Deviation | μM | Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
|
|
|
| Secondary | Time to Maximum Concentration (Tmax) of Vorinostat After a Single Oral Dose in a Fasted State | Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. | All participants who complied with the protocol and had Day 1 PK data for Tmax | Posted | Mean | Standard Deviation | Hours | Day 1: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
|
|
|
| Secondary | Tmax of Vorinostat After a Single Oral Dose in a Fed State | Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. | All participants who complied with the protocol and had Day 3 PK data for Tmax | Posted | Mean | Standard Deviation | Hours | Day 3: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
|
|
|
| Secondary | Tmax of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration | Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. | All participants who complied with the protocol and had up to Day 19 PK data for Tmax | Posted | Mean | Standard Deviation | Hours | Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
|
|
|
| Secondary | Apparent Terminal Half-Life (t½) of Vorinostat After a Single Oral Dose in a Fasted State | t½ is the elimination half-life of study drug. t½ is the time it takes for half of the study drug in the blood plasma to dissipate. | All participants who complied with the protocol and had Day 1 PK data for t½ | Posted | Mean | Standard Deviation | Hours | Day 1: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
|
|
|
| Secondary | t½ of Vorinostat After a Single Oral Dose in a Fed State | t½ is the elimination half-life of study drug. t½ is the time it takes for half of the study drug in the blood plasma to dissipate. | All participants who complied with the protocol and had Day 3 PK data for t½ | Posted | Mean | Standard Deviation | Hours | Day 3: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
|
|
|
| Secondary | t½ of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration | t½ is the elimination half-life of study drug. t½ is the time it takes for half of the study drug in the blood plasma to dissipate. | All participants who complied with the protocol and had up to Day 19 PK data for t½ | Posted | Mean | Standard Deviation | Hours | Day 19: pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose |
|
|
|
| 0 |
| 3 |
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Vorinostat 200 mg | During Cycle 1, participants received a single oral dose of vorinostat 200 mg on Day 1 (fasted), Day 3 (fed), and Day 19 (fed). On Days 5-18, participants received vorinostat 200 mg twice daily, in the morning and evening. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.) | 0 | 6 | 1 | 6 | 6 | 6 |
| EG002 | Vorinostat 400 mg | During Cycle 1, participants received a single oral dose of vorinostat 400 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 400 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle was 26 days.) | 0 | 3 | 1 | 3 | 3 | 3 |
| EG003 | Vorinostat 500 mg | During Cycle 1, participants received a single oral dose of vorinostat 500 mg on Day 1 (fasted), Day 3 (fed), Day 19 (fed). On Days 5-18, participants received a single oral dose of vorinostat 500 mg once-daily in the morning. If participants did not match to the discontinuation criteria, they could continue the same dose level therapy on the Cycle 2 and subsequent cycles. (Each cycle was 26 days.) | 0 | 6 | 0 | 6 | 6 | 6 |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Left ventricular hypertrophy | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 8.0 | Systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 8.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Oral discomfort | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 8.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood chloride decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood cholesterol decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood creatine phosphokinase MB increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood creatine phosphokinase decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood magnesium increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood triglycerides decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Blood uric acid decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Electrocardiogram ST-T change | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Electrocardiogram T wave inversion | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 8.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
| D000588 |
| Amines |
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |