Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma (0683-004)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00109109
First received: April 22, 2005
Last updated: November 17, 2014
Last verified: November 2014

April 22, 2005
November 17, 2014
December 2003
February 2006   (final data collection date for primary outcome measure)
  • PHASE I: Maximum tolerated dose (MTD) of vorinostat in patients with advanced multiple myeloma.
  • PHASE II: Safety and overall response rate to SAHA in patients with advanced multiple myeloma.
Not Provided
Complete list of historical versions of study NCT00109109 on ClinicalTrials.gov Archive Site
1) Anti-tumor activity in patients with advanced multiple myeloma; 2) Biological effects of SAHA in peripheral mononuclear cells and bone marrow plasma cells; 3) Correlation of biological effects of SAHA with serum drug concentration.
Not Provided
Not Provided
Not Provided
 
A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma (0683-004)
Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma

The purposes of this study are:

  • To determine the maximum tolerated dose (MTD) of SAHA administered every 12 hours for 14 consecutive days followed by 7 days of rest during the first two cycles (i.e., first 6 weeks) in patients with advanced multiple myeloma;
  • To assess the safety and overall response rate to SAHA in patients with advanced multiple myeloma.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment - Up to 8 Cycles or 6 months
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
February 2006
February 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients with refractory or relapsed multiple myeloma, ECOG performance status 0-2 (ECOG)
  • Adequate bone marrow reserve
  • Adequate hepatic and renal function
  • Ability to swallow capsules
  • 3 weeks or more from prior chemotherapy and have recovered from prior toxicities

Exclusion Criteria:

  • Patients who plan to go for bone marrow transplant within 4 weeks of start of treatment
  • Patients with prior treatment with other investigational agents with a similar anti-tumor mechanism
  • Patients with other active/uncontrolled clinically significant illnesses
  • Pregnant or nursing female patients
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00109109
0683-004, 2005_013
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2014

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