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

Tumors Clinical Trial

Official title:

MK0683 Phase1 Clinical Study - Solid Tumor -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373490
• Other study ID #: 0683-048
• Secondary ID: MK0683-0482006_0
• Status: Completed
• Phase: Phase 1
• First received: September 7, 2006
• Last updated: August 26, 2015
• Start date: July 2006
• Est. completion date: October 2007

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tumors

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Doi T, Hamaguchi T, Shirao K, Chin K, Hatake K, Noguchi K, Otsuki T, Mehta A, Ohtsu A. Evaluation of safety, pharmacokinetics, and efficacy of vorinostat, a histone deacetylase inhibitor, in the treatment of gastrointestinal (GI) cancer in a phase I clini — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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- 8). It is obtained from AUC (0 - t) plus AUC (t - 8). At 600 mg, t=12 hours and at 400 mg, t=24 hours.	Day 1 (600 mg and 400 mg)	No
Secondary	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 - 8)	Day 3 (600 mg)	No
Secondary	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 - 8)	Day 21 (400 mg)	No
Secondary	Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg)		Day 1 (600 mg and 400 mg)	No
Secondary	Maximum Concentration (Cmax) at Day 3 (600 mg)		Day 3 (600 mg)	No
Secondary	Maximum Concentration (Cmax) at Day 21 (400 mg)		Day 21 (400 mg)	No