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

Purpose

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.

Condition	Intervention	Phase
Lymphoma Mantle-Cell	Drug: MK-4827	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Efficacy Study of MK-4827 in Patients With Mantle Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Participants with adverse events [ Time Frame: From the day of enrollment through 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]

Enrollment:	0
Study Start Date:	December 2010
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MK-4827 All Participants	Drug: MK-4827 MK-4827 will be administered daily as an oral formulation in continuous 21-day cycles.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT01244009 History of Changes
Other Study ID Numbers:	MK-4827-002
Study First Received:	November 17, 2010
Last Updated:	May 14, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Poly (ADP-ribose) polymerase (PARP) inhibitor

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders

Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on May 22, 2013