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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01244009
First received: November 17, 2010
Last updated: May 14, 2012
Last verified: May 2012
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.:
Poly (ADP-ribose) polymerase (PARP) inhibitor

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 20, 2014