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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00373490
First Posted: September 8, 2006
Last Update Posted: August 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
September 7, 2006
September 8, 2006
October 20, 2008
May 20, 2009
August 27, 2015
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) ]
Dose Limiting Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment
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) ]
    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) [ Time Frame: 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 - ∞)
  • Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg) [ Time Frame: 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 - ∞)
  • Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg) [ Time Frame: Day 1 (600 mg and 400 mg) ]
  • Maximum Concentration (Cmax) at Day 3 (600 mg) [ Time Frame: Day 3 (600 mg) ]
  • Maximum Concentration (Cmax) at Day 21 (400 mg) [ Time Frame: Day 21 (400 mg) ]
Pharmacokinetics
Not Provided
Not Provided
 
A Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Patients With Solid Tumors (0683-048)
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 MK-0683 (vorinostat) in a Japanese patient population with solid tumors.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Tumors
  • Drug: Vorinostat
    600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest.
    Other Names:
    • MK-0683
    • Suberoylanilide Hydroxamic Acid (SAHA)
  • Drug: Vorinostat
    400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.
    Other Names:
    • MK-0683
    • Suberoylanilide Hydroxamic Acid (SAHA)
  • Experimental: Vorinostat 600 mg
    600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest.
    Intervention: Drug: Vorinostat
  • Experimental: Vorinostat 400 mg
    400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.
    Intervention: Drug: Vorinostat
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
October 2007
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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Japan
 
NCT00373490
0683-048
MK0683-048
2006_030
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2015

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