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:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00875056
First received: April 2, 2009
Last updated: May 26, 2011
Last verified: May 2011
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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:
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 2014 |
| 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
More Information
No publications provided
| Responsible Party: | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00875056 History of Changes |
| Other Study ID Numbers: | 2009_570, MK0683-103 |
| Study First Received: | April 2, 2009 |
| Last Updated: | May 26, 2011 |
| 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 Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013