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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_001 |
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The clinical study will evaluate safety, tolerability and Pharmacokinetics of MK0683 in combination with carboplatin and paclitaxel in chemotherapy-naive NSCLC patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK0683, vorinostat | Drug | vorinostat 300 mg or 400 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Dose Limited Toxicity at First Cycle | Dose Limited Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment. | 25 Days (first cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC(0-24 hr)) at Day 4 | Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour. | Day 4 |
| Area Under the Curve (AUC(0-24 hr)) at Day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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Vorinostat with Carboplatin and Paclitaxel were investigated in participants with chemotherapy-naive non-small cell lung cancer.
Enroll 3 participants to dose level 1 of vorinostat and decide whether to enroll additional participants based on the Dose Limited Toxicity (DLT) manifestation.
The starting dose of vorinostat was 300 mg once daily.
Date of first participant in: 26 January 2007. Data of last participant's last visit in study protocol: 7 March 2007. The study was conducted at single center in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vorinostat (300 mg) | This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle. |
| FG001 | Vorinostat (400 mg) | This group includes data from all participants who are treated with vorinostat 400 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle. However, no participants received vorinostat 400 mg once daily due to early discontinuation of the study based on the dose limited toxicity on vorinostat 300 mg once daily. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vorinostat (300 mg) | This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle). |
| 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 With a Dose Limited Toxicity at First Cycle | Dose Limited Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment. | All participants who received vorinostat 300 mg once daily. | Posted | Number | Participants | 25 Days (first cycle) |
|
|
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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 (300 mg) | This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract 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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Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.
| Day 5 |
| Maximum Concentration (Cmax) at Day 4 | Maximum Concentration (Cmax) = the maximum plasma concentration of the drug | Day 4 |
| Maximum Concentration (Cmax) at Day 5 | Maximum Concentration (Cmax) = the maximum plasma concentration of the drug | Day 5 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Area Under the Curve (AUC(0-24 hr)) at Day 4 | Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour. | Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 4. | Posted | Mean | Full Range | µM hr | Day 4 |
|
|
|
| Secondary | Area Under the Curve (AUC(0-24 hr)) at Day 5 | Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour. | Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 5. | Posted | Mean | Full Range | µM hr | Day 5 |
|
|
|
| Secondary | Maximum Concentration (Cmax) at Day 4 | Maximum Concentration (Cmax) = the maximum plasma concentration of the drug | Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 4. | Posted | Mean | Full Range | µM | Day 4 |
|
|
|
| Secondary | Maximum Concentration (Cmax) at Day 5 | Maximum Concentration (Cmax) = the maximum plasma concentration of the drug | Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 5. | Posted | Mean | Full Range | µM | Day 5 |
|
|
|
| 0 |
| 3 |
| 3 |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 9.1 | Non-systematic Assessment |
|
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.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000588 |
| Amines |
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |