A Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Patients With Solid Tumors (0683-048)

Study Overview
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Brief Summary
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This is a clinical study to evaluate the safety and pharmacokinetics of an overseas determined maximum tolerated dose (MTD) of MK-0683 (vorinostat) in a Japanese patient population with solid tumors.

Official Title
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MK0683 Phase1 Clinical Study - Solid Tumor -

Conditions
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Tumors

Intervention / Treatment
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* Drug: Vorinostat
* Drug: Vorinostat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically or cytologically diagnosed solid tumor in whom no standard therapy is available or the malignancy is refractory to standard therapy Exclusion Criteria: Patients with history of immunotherapy, radiotherapy, surgery, or chemotherapy during the previous 4 weeks Any uncontrolled concomitant illness Pregnant or breast-feeding Serious drug or food allergy

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vorinostat 600 mg<br>600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest. | Drug: Vorinostat<br>* 600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest.<br>* Other names: Suberoylanilide Hydroxamic Acid (SAHA);|
| Experimental: Vorinostat 400 mg<br>400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days. | Drug: Vorinostat<br>* 400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.<br>* Other names: Suberoylanilide Hydroxamic Acid (SAHA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Dose Limiting Toxicity (DLT) | Dose Limiting Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment | 21 Days (first cycle) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC(0-infinity)) at Day 1 (600 mg and 400 mg) | Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (o- ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). At 600 mg, t=12 hours and at 400 mg, t=24 hours. | Day 1 (600 mg and 400 mg) | 
| Area Under the Curve (AUC(0-infinity)) at Day 3 (600 mg) | Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 12) plus AUC (12 - ∞) | Day 3 (600 mg) | 
| Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg) | Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 24) plus AUC (24 - ∞) | Day 21 (400 mg) | 
| Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg) |  | Day 1 (600 mg and 400 mg) | 
| Maximum Concentration (Cmax) at Day 3 (600 mg) |  | Day 3 (600 mg) | 
| Maximum Concentration (Cmax) at Day 21 (400 mg) |  | Day 21 (400 mg) |