Clinical trial NCT01244009: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Lymphoma
Mantle-Cell
Keywords: Poly (ADP-ribose) polymerase (PARP) inhibitor
Lead sponsor: Tesaro, Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of participants who have a complete response (CR) or partial response (PR) during the study
timeFrame: 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 outcomes:
measure: Number of Participants with adverse events
timeFrame: From the day of enrollment through 30 days after the last dose of study drug
measure: Time from allocation to disease progression or death from any cause (Progression-free survival)
timeFrame: 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
Other outcomes:
Locations:
Study officials:
References: