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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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00373490
First received: September 7, 2006
Last updated: June 19, 2014
Last verified: June 2014

September 7, 2006
June 19, 2014
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 ]
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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ 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 (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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00373490
0683-048, MK0683-048, 2006_030
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2014

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