- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01244009
A Study of MK-4827 for the Treatment of Mantle Cell Lymphoma (MK-4827-002)
November 3, 2016 updated by: Tesaro, Inc.
A Phase II Efficacy Study of MK-4827 in Patients With Mantle Cell Lymphoma
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.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MK-4827
All Participants
|
MK-4827 will be administered daily as an oral formulation in continuous 21-day cycles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants who have a complete response (CR) or partial response (PR) during the study
Time Frame: 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
|
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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with adverse events
Time Frame: From the day of enrollment through 30 days after the last dose of study drug
|
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)
Time Frame: 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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Anticipated)
August 1, 2013
Study Completion (Anticipated)
August 1, 2013
Study Registration Dates
First Submitted
November 17, 2010
First Submitted That Met QC Criteria
November 17, 2010
First Posted (Estimate)
November 19, 2010
Study Record Updates
Last Update Posted (Estimate)
November 6, 2016
Last Update Submitted That Met QC Criteria
November 3, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Mantle-Cell
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Poly(ADP-ribose) Polymerase Inhibitors
- Niraparib
Other Study ID Numbers
- MK-4827-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lymphoma
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Marcela V. Maus, M.D.,Ph.D.RecruitingFollicular Lymphoma | Mantle Cell Lymphoma | Marginal Zone Lymphoma | Diffuse Large B Cell Lymphoma | Refractory Non-Hodgkin Lymphoma | Primary Mediastinal Large B-cell Lymphoma (PMBCL) | Non-hodgkin Lymphoma | High-grade B-cell Lymphoma | Grade 3b Follicular Lymphoma | Relapsed Non-Hodgkin LymphomaUnited States
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Novartis PharmaceuticalsBristol-Myers SquibbRecruitingNon-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone LymphomaUnited States, Germany, Italy, Korea, Republic of, Spain, Singapore, China, Japan, Australia
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IGM Biosciences, Inc.ADC Therapeutics S.A.Active, not recruitingFollicular Lymphoma | Mantle Cell Lymphoma | Marginal Zone Lymphoma | Non-Hodgkin Lymphoma | DLBCLUnited States, Korea, Republic of, Spain, France, Australia, Czechia, Italy
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Zhejiang UniversityShanghai First Song Therapeutics Co., LtdNot yet recruitingHodgkin Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Diffuse Large B Cell Lymphoma | Gray Zone Lymphoma | NK/T Cell Lymphoma | Peripheral T Cell Lymphoma, Unspecified | Mediastinal B-Cell Diffuse Large Cell LymphomaChina
-
Massachusetts General HospitalTG TherapeuticsActive, not recruitingLymphoma | Follicular Lymphoma | Marginal Zone Lymphoma | Follicular Lymphoma, Grade 1 | Follicular Lymphoma Grade IIIa | Marginal Zone B Cell Lymphoma | Follicular Lymphoma Grade 2United States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedFollicular Lymphoma | Mantle Cell Lymphoma | Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | Adult Diffuse Large B-Cell Lymphoma | T-Cell Non-Hodgkin LymphomaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedMantle Cell Lymphoma | Marginal Zone Lymphoma | Non-Hodgkin Lymphoma | Small Lymphocytic Lymphoma | Lymphoproliferative Disorder | Primary Cutaneous B-Cell Non-Hodgkin Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Grade 3 Follicular... and other conditionsUnited States, Canada, Australia, Puerto Rico
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Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedFollicular Lymphoma | Mantle Cell Lymphoma | Non-Hodgkin Lymphoma | Peripheral T-cell Lymphoma | Diffuse Large B-cell LymphomaUnited States
-
Novartis PharmaceuticalsCompletedDiffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular LymphomaUnited States, Belgium, Germany, France, Italy, Korea, Republic of, Spain, Turkey
-
SymBio PharmaceuticalsCompletedFollicular Lymphoma | Non-Hodgkin's Lymphoma | Lymphoma, Large Cell | Diffuse, Mantle Cell Lymphoma, Lymphoma | Large B-Cell, DiffuseJapan, Korea, Republic of
Clinical Trials on MK-4827
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Tesaro, Inc.CompletedChronic Lymphocytic Leukemia | Solid Tumors | T-cell-prolymphocytic Leukemia
-
Merck Sharp & Dohme LLCTerminatedNeoplasms | Solid Tumors
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M.D. Anderson Cancer CenterRecruiting
-
Haider MahdiGlaxoSmithKline; Zenith EpigeneticsRecruitingOvarian Cancer | Recurrent Solid TumorsUnited States
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Georgetown UniversityOregon Health and Science University; Tesaro, Inc.TerminatedHomologous Recombination Deficiency | Solid Tumor, AdultUnited States
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Tesaro, Inc.European Organisation for Research and Treatment of Cancer - EORTC; Breast... and other collaboratorsTerminatedOvarian Neoplasms | BRCA1 Gene Mutation | BRCA2 Gene Mutation | Neoplasms, Breast | Human Epidermal Growth Factor 2 Negative Carcinoma of Breast | Carcinoma of BreastUnited States, Spain, Belgium, Israel, United Kingdom, Italy, Poland, Canada, Hungary, Netherlands, France, Portugal, Greece, Iceland
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University of Alabama at BirminghamTesaro, Inc.; Susan G. Komen Breast Cancer Foundation; Translational Breast Cancer... and other collaboratorsRecruitingMetastatic Breast Cancer | HER2 Positive Breast CarcinomaUnited States
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University Of PerugiaUnknownThe Primary Study Objective is to Assess the Efficacy and | Safety of Extended 4-week Heparin Prophylaxis Compared to | Prophylaxis Given for 8±2 Days After Planned Laparoscopic | Surgery for Colorectal Cancer. | The Clinical Benefit Will be Evaluated as the Difference in | the Incidence of... and other conditionsItaly
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Merck Sharp & Dohme LLCCompletedMelanoma | Glioblastoma Multiforme | Recurrence of Solid Tumor
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Marc Dall'Era, MDNational Cancer Institute (NCI); Janssen, LPRecruitingBRCA1 Gene Mutation | BRCA2 Gene Mutation | Prostate Carcinoma | RAD51C Gene Mutation | BRIP1 Gene Mutation | ATM Gene Mutation | CHEK2 Gene Mutation | NBN Gene Mutation | RAD51 Gene Mutation | CDK12 Gene Mutation | CHEK1 Gene Mutation | DNA Damage Response Gene Mutation | DNA Repair Gene Mutation | FANCA Gene Mutation and other conditionsUnited States