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WithdrawnNCT01244009Updated Nov 6, 2016

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

A Phase 2 interventional study of MK-4827 in Lymphoma and Mantle-Cell, sponsored by Tesaro, Inc.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-06.

Sponsored by Tesaro, Inc. · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Sponsor decision
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lymphoma
  • Mantle-Cell

Keywords

  • Poly (ADP-ribose) polymerase (PARP) inhibitor
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

Browse Lymphoma studies →

Lead sponsor

Tesaro, Inc. is the lead sponsor of 32 studies on the registry; none are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 12 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    MK-4827

    All Participants

    Drug: MK-4827

Interventions

  • DrugMK-4827

    MK-4827 will be administered daily as an oral formulation in continuous 21-day cycles.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Participants with adverse events

    Time frame: From the day of enrollment through 30 days after the last dose of study drug

  2. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01244009
Lead sponsor
Tesaro, Inc.
First posted
Nov 19, 2010
Start date
Dec 2010
Primary completion
Aug 2013 (estimated)
Completion
Aug 2013 (estimated)
Last update
Nov 6, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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