A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Solid Tumors (0683-029)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00127127
First received: August 3, 2005
Last updated: February 27, 2014
Last verified: February 2014

August 3, 2005
February 27, 2014
June 2005
August 2009   (final data collection date for primary outcome measure)
Safety [ Time Frame: Duration of Trial ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00127127 on ClinicalTrials.gov Archive Site
Pharmacokinetics [ Time Frame: Duration of Trial ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Solid Tumors (0683-029)(COMPLETED)
A Phase I Clinical Study of MK0683 in Patients With Solid Tumors.

The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral suberoylanilide hydroxamic acid in patients with solid tumors.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Tumors
Drug: vorinostat, Suberoylanilide Hydroxamic Acid (SAHA)
vorinostat; level 1: 100 mg BID 14-day, level 2: 200 mg BID 14-day, level 3: 400 mg QD 14 day, level 5: 500 mg QD 14-day
Other Names:
  • MK0683
  • vorinostat
  • SAHA
Experimental: 1
1. level 1: 100 mg BID 14-day, level 2: 200 mg BID 14-day, level 3: 400 mg QD 14 day, level 5: 500 mg QD 14-day
Intervention: Drug: vorinostat, Suberoylanilide Hydroxamic Acid (SAHA)
Fujiwara Y, Yamamoto N, Yamada Y, Yamada K, Otsuki T, Kanazu S, Iwasa T, Hardwick JS, Tamura T. Phase I and pharmacokinetic study of vorinostat (suberoylanilide hydroxamic acid) in Japanese patients with solid tumors. Cancer Sci. 2009 May 31; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with histologically or cytologically diagnosed solid tumor; no standard therapy available or patient has failed to respond to standard therapy

Exclusion Criteria:

  • Patients with history of immunotherapy, radiotherapy, surgery, or chemotherapy during the previous 4 weeks; previous treatment is 5 or more chemotherapeutic regimens.
  • Any uncontrolled concomitant illness
  • Are pregnant or breast-feeding
  • Serious drug or food allergy
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00127127
0683-029, 2005_040
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2014

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