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An Investigational Drug Study With Suberoylanilide Hydroxamic Acid in Relapsed Diffuse Large B-cell Lymphoma (0683-013)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00097929
First received: December 1, 2004
Last updated: April 5, 2017
Last verified: April 2017

December 1, 2004
April 5, 2017
May 1, 2005
July 31, 2006   (Final data collection date for primary outcome measure)
Objective response rate based on FDG-PET and CT scan findings.
Not Provided
Complete list of historical versions of study NCT00097929 on ClinicalTrials.gov Archive Site
Response duration, Progression-free survival, Time to progression, Time to response, 3-Month and 6-month progression free survival.
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An Investigational Drug Study With Suberoylanilide Hydroxamic Acid in Relapsed Diffuse Large B-cell Lymphoma (0683-013)
A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
A study to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug in the treatment of relapsed diffuse large B-cell lymphoma.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
B-cell Lymphoma
Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months
Not Provided
Crump M, Coiffier B, Jacobsen ED, Sun L, Ricker JL, Xie H, Frankel SR, Randolph SS, Cheson BD. Phase II trial of oral vorinostat (suberoylanilide hydroxamic acid) in relapsed diffuse large-B-cell lymphoma. Ann Oncol. 2008 May;19(5):964-9. doi: 10.1093/annonc/mdn031. Epub 2008 Feb 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 31, 2006
July 31, 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient must be 18 years or older with relapsed Diffuse Large B-cell Lymphoma (DLBCL).
  • Stable disease or better for at least 3 months on most recent treatment
  • Have not received any chemotherapy, radiation therapy, major surgery, or any other investigational therapy for at least 4 weeks prior to entry in this study
  • Adequate blood testing, liver, and kidney function as required by the study.
  • Eligible subjects will allow tissue samples to be examined and stored.

Exclusion Criteria:

  • Patient has been treated with other investigational agents with a similar anti-tumor mechanism.
  • Patient should not have failed more than 3 prior treatment regimens.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Belgium,   Canada,   France,   United Kingdom,   United States
 
NCT00097929
0683-013
MK0683-013
2004_029
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
April 2017

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