Study of Vorinostat (MK0683) With Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL) or Mantle Cell Lymphoma (MCL) Patients (0683-103)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00875056
First received: April 2, 2009
Last updated: May 26, 2011
Last verified: May 2011

April 2, 2009
May 26, 2011
April 2009
February 2011   (final data collection date for primary outcome measure)
Overall Response Rate [ Time Frame: 21 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00875056 on ClinicalTrials.gov Archive Site
Time to event efficacy endpoints 2)Any clinical or laboratory adverse experiences [ Time Frame: 21 Months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Vorinostat (MK0683) With Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL) or Mantle Cell Lymphoma (MCL) Patients (0683-103)
A Phase II Study of MK0683 in Patients With Relapsed / Refractory Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL) or Mantle Cell Lymphoma (MCL)

This study evaluates safety and tolerability of MK0683 and efficacy of MK0683 in patients with relapsed and/or refractory FL. Exploratory purpose of this study is to evaluate efficacy of MK0683 in patients with relapsed and/or refractory other Indolent B-NHL or MCL.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
Drug: vorinostat
MK0683 (200 mg capsule) Oral, twice daily (400 mg/day) for Day 1 through 14 of a 21 day cycle
Experimental: 1
vorinostat
Intervention: Drug: vorinostat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
54
January 2014
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient Is 20 To 74 Years Old
  • Patient Has An Histopathologically Confirmed Fl, Or Other Indolent B-Nhl Or Mcl (Only Relapsed / Refractory Fl Can Be Included Outside Japan.)
  • Patient Has At Least One Measurable Lesion By Ct Scan Which Is Defined By Cheson's 1999 Criteria
  • Patient Has Received At Least 1 But Up To 4 Prior Chemotherapeutic Regimen, The Most Recent Therapy Must Have Failed To Induce A Partial Response, Or There Must Be Recurrence In Case Of The Most Recent Therapy Has Shown Complete Response, Or There Must Be Relapse In Case Of The Most Recent Therapy Has Shown Partial Response.
  • Patient Must Have Adequate Organ And Marrow function

Exclusion Criteria:

  • Patient Who Has Undergone Allogenic Transplant Treatment Or Autologous Stem Cell Transplant Within 6 Months
  • Patient With Other Active Malignancies Or Central Neurological Infiltration With Lymphoma
  • Patient With Severe Hepatic Insufficiency
  • Patient With History Of Allergic Reactions Attributed To Any Component Of MK0683
  • Patient Who Is Known To Be HIV Antibody-, Hbv Antigen- Or Hcv Antibody-Positive
  • Patient Who Has Undergone Prior/Concomitant Treatment With MK0683 Or Other Hdac Inhibitors
Both
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00875056
2009_570, MK0683-103
No
Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
May 2011

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