A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00373490
First received: September 7, 2006
Last updated: May 20, 2009
Last verified: May 2009

September 7, 2006
May 20, 2009
July 2006
October 2007   (final data collection date for primary outcome measure)
Number of Participants With a Dose Limiting Toxicity (DLT) [ Time Frame: 21 Days (first cycle) ] [ Designated as safety issue: Yes ]
Safety
Complete list of historical versions of study NCT00373490 on ClinicalTrials.gov Archive Site
  • Area Under the Curve (AUC(0-Infinity)) at Day 1 (600 mg and 400 mg) [ Time Frame: Day 1 (600 mg and 400 mg) ] [ Designated as safety issue: No ]
  • Area Under the Curve (AUC(0-Infinity)) at Day 3 (600 mg) [ Time Frame: Day 3 (600 mg) ] [ Designated as safety issue: No ]
  • Area Under the Curve (AUC(0-Infinity) at Day 21 (400 mg) [ Time Frame: Day 21 (400 mg) ] [ Designated as safety issue: No ]
  • Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg) [ Time Frame: Day 1 (600 mg and 400 mg) ] [ Designated as safety issue: No ]
  • Maximum Concentration (Cmax) at Day 3 (600 mg) [ Time Frame: Day 3 (600 mg) ] [ Designated as safety issue: No ]
  • Maximum Concentration (Cmax) at Day 21 (400 mg) [ Time Frame: Day 21 (400 mg) ] [ Designated as safety issue: No ]
Pharmacokinetics
Not Provided
Not Provided
 
A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Solid Tumors
MK0683 Phase1 Clinical Study - Solid Tumor -

This is a clinical study to evaluate the safety and pharmacokinetics of an overseas determined maximum tolerated dose (MTD) of MK0683 (suberoylanilide hydroxamic acid) in a Japanese patient population with solid tumors.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Tumors
  • Drug: Suberoylanilide Hydroxamic Acid (SAHA)
    600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest.
    Other Names:
    • MK0683
    • vorinostat
  • Drug: Suberoylanilide Hydroxamic Acid (SAHA)
    400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.
    Other Names:
    • MK0683
    • vorinostat
  • Experimental: Suberoylanilide Hydroxamic Acid (600 mg)
    Intervention: Drug: Suberoylanilide Hydroxamic Acid (SAHA)
  • Experimental: Suberoylanilide Hydroxamic Acid (400 mg)
    Intervention: Drug: Suberoylanilide Hydroxamic Acid (SAHA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2008
October 2007   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00373490
2006_030, MK0683-048
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP