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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)

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ClinicalTrials.gov Identifier: NCT00875056
Recruitment Status : Active, not recruiting
First Posted : April 3, 2009
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Lymphoma Drug: vorinostat Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Actual Study Start Date : April 15, 2009
Actual Primary Completion Date : February 25, 2011
Estimated Study Completion Date : January 31, 2019


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 21 Months ]

Secondary Outcome Measures :
  1. Time to event efficacy endpoints 2)Any clinical or laboratory adverse experiences [ Time Frame: 21 Months ]


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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875056


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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00875056     History of Changes
Other Study ID Numbers: 0683-103
2009_570
132248 ( Registry Identifier: JAPIC-CTI )
First Posted: April 3, 2009    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

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