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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Tumors

Treatments: Drug: Vorinostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT00373490

0683-048

2006_030

MK0683-048

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

16 participants in 2 patient groups

Vorinostat 600 mg

Experimental group

Description:

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

Treatment:

Drug: Vorinostat

Drug: Vorinostat

Vorinostat 400 mg

Experimental group

Description:

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

Treatment:

Drug: Vorinostat

Drug: Vorinostat