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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-10-31

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.

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Detailed Description

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Conditions

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Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vorinostat 600 mg

600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest.

Group Type EXPERIMENTAL

Vorinostat

Intervention Type DRUG

600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest.

Vorinostat 400 mg

400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.

Group Type EXPERIMENTAL

Vorinostat

Intervention Type DRUG

400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.

Interventions

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Vorinostat

600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest.

Intervention Type DRUG

Vorinostat

400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.

Intervention Type DRUG

Other Intervention Names

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MK-0683 Suberoylanilide Hydroxamic Acid (SAHA) MK-0683 Suberoylanilide Hydroxamic Acid (SAHA)

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No