Lymphoma, Mantle-Cell
Conditions
Keywords
Poly (ADP-ribose) polymerase (PARP) inhibitor
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.
Interventions
DRUGMK-4827
MK-4827 will be administered daily as an oral formulation in continuous 21-day cycles.
Sponsors
Tesaro, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants who have a complete response (CR) or partial response (PR) during the study | 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
| Measure | Time frame |
|---|---|
| Number of Participants with adverse events | From the day of enrollment through 30 days after the last dose of study drug |
| Time from allocation to disease progression or death from any cause (Progression-free survival) | 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 |
Outcome results
None listed