Status:
WITHDRAWN
A Study of MK-4827 for the Treatment of Mantle Cell Lymphoma (MK-4827-002)
Lead Sponsor:
Tesaro, Inc.
Conditions:
Lymphoma
Mantle-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 M...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01244009
Start Date
December 1 2010
End Date
August 1 2013
Last Update
November 7 2016
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