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

NCT ID: NCT01244009

Last Updated: 2016-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma Mantle-Cell

Keywords

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Poly (ADP-ribose) polymerase (PARP) inhibitor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MK-4827

All Participants

Group Type EXPERIMENTAL

MK-4827

Intervention Type DRUG

MK-4827 will be administered daily as an oral formulation in continuous 21-day cycles.

Interventions

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MK-4827

MK-4827 will be administered daily as an oral formulation in continuous 21-day cycles.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tesaro, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Merck Sharp & Dohme Corp

Other Identifiers

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MK-4827-002

Identifier Type: -

Identifier Source: org_study_id