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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_575 |
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This study determines recommended clinical dose, to evaluate the safety, tolerability and pharmacokinetics of MK-1496 in patients with locally advanced and/or metastatic solid tumors who have failed standard therapy or for whom no standard therapy exists, in two dosing schedules in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-1496 20 mg (21-Day Cycle) | Experimental | Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle |
|
| MK-1496 40 mg (21-Day Cycle) | Experimental | Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle |
|
| MK-1496 80 mg (21-Day Cycle) | Experimental | Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle |
|
| MK-1496 120 mg (21-Day Cycle) | Experimental | Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle |
|
| MK-1496 20 mg (28-Day Cycle) | Experimental | Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
|
| MK-1496 40 mg (28-Day Cycle) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1496 | Drug | MK-1496 (20 to 120 mg), orally, administered on Day 1 of each 21-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLTs) | Dose-limiting toxicities (DLTs) are any adverse events that are not clearly related to disease progression including Grade 4 neutropenia, Grade 3 or 4 febrile neutropenia, thrombocytopenic bleeding or Grade 4 thrombocytopenia, and any Grade 3 or 4 non hematologic toxicity. An adverse event (AE) is any unfavorable and unintended change in the structure and function (Clinical AE) or chemistry (Laboratory AE) of the body temporally associated with the use of study product, whether or not considered related to the use of the product. | Cycle 1 (up to 21 or 28 days, depending on treatment arm) |
| Number of Participants With Any Clinical or Laboratory Adverse Event | This is a measure of the number of participants who experienced any adverse event (AE) while on study. | First dose up to 30 days after last dose (up to 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle) | AUC[0-24] is a measure of the total plasma exposure of drug over a 24-hour period after the initial dose; for this analysis AUC was measured on Day 1 of the first 21-day cycle. AUC[0-24] for the 28-day cycle is reported as Outcome Measures 4 and 5. | Cycle 1, Day 1 (Hour 0 through Hour 24) |
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Inclusion Criteria
Exclusion Criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-1496 20 mg (21-Day Cycle) | Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle |
| FG001 | MK-1496 40 mg (21-Day Cycle) | Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle |
| FG002 | MK-1496 80 mg (21-Day Cycle) | Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle |
| FG003 | MK-1496 120 mg (21-Day Cycle) | Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle |
| FG004 | MK-1496 20 mg (28-Day Cycle) | Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| FG005 | MK-1496 40 mg (28-Day Cycle) | Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| FG006 | MK-1496 80 mg (28-Day Cycle) | Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| FG007 | MK-1496 100 mg (28-Day Cycle) | Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| FG008 | MK-1496 120 mg (28-Day Cycle) | Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-1496 20 mg (21-Day Cycle) | Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle |
| BG001 | MK-1496 40 mg (21-Day Cycle) | Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicities (DLTs) | Dose-limiting toxicities (DLTs) are any adverse events that are not clearly related to disease progression including Grade 4 neutropenia, Grade 3 or 4 febrile neutropenia, thrombocytopenic bleeding or Grade 4 thrombocytopenia, and any Grade 3 or 4 non hematologic toxicity. An adverse event (AE) is any unfavorable and unintended change in the structure and function (Clinical AE) or chemistry (Laboratory AE) of the body temporally associated with the use of study product, whether or not considered related to the use of the product. | All participants in the first cycle of each dosing schedule (21 or 28 days) | Posted | Number | participants | Cycle 1 (up to 21 or 28 days, depending on treatment arm) |
|
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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 | MK-1496 20 mg (21-Day Cycle) | Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Late Stage Development Group Leader | Merck Sharp & Dohme | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
|
| MK-1496 80 mg (28-Day Cycle) | Experimental | Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
|
| MK-1496 100 mg (28-Day Cycle) | Experimental | Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
|
| MK-1496 120 mg (28-Day Cycle) | Experimental | Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
|
| MK-1496 | Drug | MK-1496 (20 to 120 mg), orally, administered on Days 1 and 3 each week for 3 weeks (Days 1, 3, 8, 10, 15 and 17) of each 28-day cycle |
|
| Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle) | AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 1 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements. AUC[0-24] for the Day 3 doses is reported as Outcome Measure 5. | Cycle 1, Day 1 (Hour 0 through Hour 24) |
| Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle) | AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 3 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements. AUC[0-24] for the Day 1 doses is reported as Outcome Measure 4. | Cycle 1, Day 3 (Hour 0 through Hour 24) |
| Adverse Event |
|
| Withdrawal by Subject |
|
| BG002 | MK-1496 80 mg (21-Day Cycle) | Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle |
| BG003 | MK-1496 120 mg (21-Day Cycle) | Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle |
| BG004 | MK-1496 20 mg (28-Day Cycle) | Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| BG005 | MK-1496 40 mg (28-Day Cycle) | Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| BG006 | MK-1496 80 mg (28-Day Cycle) | Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| BG007 | MK-1496 100 mg (28-Day Cycle) | Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| BG008 | MK-1496 120 mg (28-Day Cycle) | Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| BG009 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | MK-1496 40 mg (21-Day Cycle) | Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle |
| OG002 | MK-1496 80 mg (21-Day Cycle) | Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle |
| OG003 | MK-1496 120 mg (21-Day Cycle) | Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle |
| OG004 | MK-1496 20 mg (28-Day Cycle) | Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| OG005 | MK-1496 40 mg (28-Day Cycle) | Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| OG006 | MK-1496 80 mg (28-Day Cycle) | Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| OG007 | MK-1496 100 mg (28-Day Cycle) | Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| OG008 | MK-1496 120 mg (28-Day Cycle) | Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
|
|
| Secondary | Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle) | AUC[0-24] is a measure of the total plasma exposure of drug over a 24-hour period after the initial dose; for this analysis AUC was measured on Day 1 of the first 21-day cycle. AUC[0-24] for the 28-day cycle is reported as Outcome Measures 4 and 5. | All participants on the 21-day dosing schedule | Posted | Mean | Standard Deviation | hr*nmol/L | Cycle 1, Day 1 (Hour 0 through Hour 24) |
|
|
|
| Secondary | Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle) | AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 1 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements. AUC[0-24] for the Day 3 doses is reported as Outcome Measure 5. | All participants in the first cycle of the 28-day dosing schedule | Posted | Mean | Standard Deviation | hr*nmol/L | Cycle 1, Day 1 (Hour 0 through Hour 24) |
|
|
|
| Secondary | Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle) | AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 3 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements. AUC[0-24] for the Day 1 doses is reported as Outcome Measure 4. | All participants in the first 28-day cycle | Posted | Mean | Standard Deviation | hr*nmol/L | Cycle 1, Day 3 (Hour 0 through Hour 24) |
|
|
|
| Primary | Number of Participants With Any Clinical or Laboratory Adverse Event | This is a measure of the number of participants who experienced any adverse event (AE) while on study. | All participants on study | Posted | Number | participants | First dose up to 30 days after last dose (up to 2 years) |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | MK-1496 40 mg (21-Day Cycle) | Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle | 0 | 3 | 3 | 3 |
| EG002 | MK-1496 80 mg (21-Day Cycle) | Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle | 0 | 3 | 2 | 3 |
| EG003 | MK-1496 120 mg (21-Day Cycle) | Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle | 1 | 1 | 1 | 1 |
| EG004 | MK-1496 20 mg (28-Day Cycle) | Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle | 1 | 3 | 3 | 3 |
| EG005 | MK-1496 40 mg (28-Day Cycle) | Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle | 0 | 3 | 3 | 3 |
| EG006 | MK-1496 80 mg (28-Day Cycle) | Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle | 2 | 6 | 6 | 6 |
| EG007 | MK-1496 100 mg (28-Day Cycle) | Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle | 2 | 2 | 2 | 2 |
| EG008 | MK-1496 120 mg (28-Day Cycle) | Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle | 1 | 3 | 3 | 3 |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Cheilitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bactaermia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperlipasaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hyperphosphatasaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Ketonuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 13.1 | 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. Any information identified by the Sponsor as confidential must be deleted prior to submission.