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

Primary Purpose

Lymphoma, Mantle-Cell

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK-4827
Sponsored by
Tesaro, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Poly (ADP-ribose) polymerase (PARP) inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MK-4827

    Arm Description

    All Participants

    Outcomes

    Primary Outcome Measures

    Number of participants who have a complete response (CR) or partial response (PR) during the study

    Secondary Outcome Measures

    Number of Participants with adverse events
    Time from allocation to disease progression or death from any cause (Progression-free survival)

    Full Information

    First Posted
    November 17, 2010
    Last Updated
    November 3, 2016
    Sponsor
    Tesaro, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01244009
    Brief Title
    A Study of MK-4827 for the Treatment of Mantle Cell Lymphoma (MK-4827-002)
    Official Title
    A Phase II Efficacy Study of MK-4827 in Patients With Mantle Cell Lymphoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sponsor decision
    Study Start Date
    December 2010 (undefined)
    Primary Completion Date
    August 2013 (Anticipated)
    Study Completion Date
    August 2013 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Tesaro, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma, Mantle-Cell
    Keywords
    Poly (ADP-ribose) polymerase (PARP) inhibitor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MK-4827
    Arm Type
    Experimental
    Arm Description
    All Participants
    Intervention Type
    Drug
    Intervention Name(s)
    MK-4827
    Intervention Description
    MK-4827 will be administered daily as an oral formulation in continuous 21-day cycles.
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Number of Participants with adverse events
    Time Frame
    From the day of enrollment through 30 days after the last dose of study drug
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

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