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A Study of MK-4827 for the Treatment of Mantle Cell Lymphoma (MK-4827-002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01244009
Recruitment Status : Withdrawn (Sponsor decision)
First Posted : November 19, 2010
Last Update Posted : November 7, 2016
Sponsor:
Information provided by:

Study Description
Brief Summary:
This study will investigate the efficacy and safety of MK-4827 in participants with relapsed mantle cell lymphoma (MCL) and in a subset of participants with inactivation of the Ataxia-Telangiectasia Mutated (ATM) gene.

Condition or disease Intervention/treatment Phase
Lymphoma Mantle-Cell Drug: MK-4827 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Efficacy Study of MK-4827 in Patients With Mantle Cell Lymphoma
Study Start Date : December 2010
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: MK-4827
All Participants
Drug: MK-4827
MK-4827 will be administered daily as an oral formulation in continuous 21-day cycles.


Outcome Measures

Primary Outcome Measures :
  1. Number of participants who have a complete response (CR) or partial response (PR) during the study [ Time Frame: Tumor assessments will be performed every 9 weeks for the first year the participant is on treatment, every 12 weeks in year 2, and every 6 months in year 3 and beyond ]

Secondary Outcome Measures :
  1. Number of Participants with adverse events [ Time Frame: From the day of enrollment through 30 days after the last dose of study drug ]
  2. Time from allocation to disease progression or death from any cause (Progression-free survival) [ Time Frame: Tumor assessments will be performed every 9 weeks for the first year the participant is on treatment, every 12 weeks in year 2, and every 6 months in year 3 and beyond ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria :

  • Participant must have a diagnosis of MCL that has relapsed after at least one prior chemotherapy regimen or for which the participant has refused standard therapy
  • Participant has measureable disease defined by lymphadenopathy, organomegaly, bone marrow involvement and/or circulating lymphoma cells. At least one lesion must be > 2 cm in the longest diameter and measurable in 2 perpendicular dimensions
  • Participant has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
  • Female participants of child-bearing potential agree to use two approved contraceptive methods or remain abstinent throughout the study
  • Male participants agree to use an adequate method of contraception throughout the study
  • Participant has no history of prior cancer except certain cervical, skin, or prostate cancers, or has undergone potentially curative therapy with no recurrence for five years, or is deemed at low risk for recurrence
  • Participant has not had any platelet or red blood cell transfusions or colony stimulating factor support during the month prior to treatment
  • Participant has a pre-study diagnostic formalin fixed paraffin-embedded tumor tissue sample available

Exclusion Criteria :

  • Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks of screening
  • Participant has a history of central nervous system (CNS) lymphoma
  • Participant requires the use of corticosteroids
  • Participant is pregnant, breastfeeding, or expecting to conceive or father children during the study
  • Participant is known to be human immunodeficiency virus (HIV)-positive
  • Participant has a history of Hepatitis B or C
More Information

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01244009     History of Changes
Other Study ID Numbers: MK-4827-002
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016

Keywords provided by Tesaro, Inc.:
Poly (ADP-ribose) polymerase (PARP) inhibitor

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Niraparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents