Overview

This trial is active, not recruiting.

Condition lymphoma
Treatment vorinostat
Phase phase 2
Target HDAC
Sponsor Merck Sharp & Dohme Corp.
Start date April 2009
End date February 2011
Trial size 54 participants
Trial identifier NCT00875056, 0683-103, 132248, 2009_570

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
vorinostat
vorinostat
MK0683 (200 mg capsule) Oral, twice daily (400 mg/day) for Day 1 through 14 of a 21 day cycle

Primary Outcomes

Measure
Overall Response Rate
time frame: 21 Months

Secondary Outcomes

Measure
Time to event efficacy endpoints 2)Any clinical or laboratory adverse experiences
time frame: 21 Months

Eligibility Criteria

Male or female participants from 20 years up to 74 years old.

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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..