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

Tesaro

Status and phase

Withdrawn

Phase 2

Conditions

Mantle-Cell

Lymphoma

Treatments

Drug: MK-4827

Study type

Interventional

Funder types

Industry

Identifiers

NCT01244009

MK-4827-002

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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