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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00875056
First received: April 2, 2009
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: vorinostat
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: 21 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to event efficacy endpoints 2)Any clinical or laboratory adverse experiences [ Time Frame: 21 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: April 2009
Estimated Study Completion Date: January 2017
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
vorinostat
Drug: vorinostat
MK0683 (200 mg capsule) Oral, twice daily (400 mg/day) for Day 1 through 14 of a 21 day cycle

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875056

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00875056     History of Changes
Other Study ID Numbers: 0683-103, 2009_570
Study First Received: April 2, 2009
Last Updated: July 29, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Vorinostat
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014