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

NCT00373490 | Completed Phase 1 Results

• 3 other identifiers: 0683-048MK0683-0482006_030
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Area Under the Curve (AUC(0-infinity)) at Day 1 (600 mg and 400 mg)

  Day 1 (600 mg and 400 mg)

• Area Under the Curve (AUC(0-infinity)) at Day 3 (600 mg)

  Day 3 (600 mg)

• Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg)

  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)

Study Arms (2)

Vorinostat 600 mg

EXPERIMENTAL

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

Drug: Vorinostat

Vorinostat 400 mg

EXPERIMENTAL

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

Drug: Vorinostat

Interventions

Vorinostat DRUG

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

Also known as: MK-0683, Suberoylanilide Hydroxamic Acid (SAHA)

Vorinostat 600 mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically or cytologically diagnosed solid tumor in whom no standard therapy is available or the malignancy is refractory to standard therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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 clinical trial. Int J Clin Oncol. 2013 Feb;18(1):87-95. doi: 10.1007/s10147-011-0348-6. Epub 2012 Jan 11.

  PMID: 22234637 RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

Vorinostat

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydroxamic Acids; Hydroxylamines; Hydroxy Acids; Carboxylic Acids

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2006
• First Posted: September 8, 2006
• Study Start: July 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: August 27, 2015
• Results First Posted: May 20, 2009

Record last verified: 2015-08