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This study has been withdrawn prior to enrollment.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

November 17, 2010
May 14, 2012
December 2010
August 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01244009 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of MK-4827 for the Treatment of Mantle Cell Lymphoma (MK-4827-002)
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma
  • Mantle-Cell
Drug: MK-4827
MK-4827 will be administered daily as an oral formulation in continuous 21-day cycles.
Experimental: MK-4827
All Participants
Intervention: Drug: MK-4827
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01244009
MK-4827-002
No
Vice President of Late Stage Development, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP