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

Phase 1

Completed

• Conditions: Tumors
• Interventions: Drug: Vorinostat

• Registration Number: NCT00373490
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-09-07
• Study First Submitted QC: 2006-09-07
• Study First Posted: 2006-09-08
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Results First Submitted: 2008-10-20
• Results First Submitted QC: 2009-03-30
• Results First Posted: 2009-05-20
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-26
• Last Update Posted: 2015-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vorinostat 600 mg	Vorinostat	600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest.
Vorinostat 400 mg	Vorinostat	400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC(0-infinity)) at Day 1 (600 mg and 400 mg)	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.
Area Under the Curve (AUC(0-infinity)) at Day 3 (600 mg)	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 - ∞)
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)
Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg)	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 - ∞)