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

NCT01244009 | Withdrawn Phase 2

• 1 other identifier: MK-4827-002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lymphoma; Mantle-Cell

Keywords

Poly (ADP-ribose) polymerase (PARP) inhibitor

Outcome Measures

Primary Outcomes (1)

• Number of participants who have a complete response (CR) or partial response (PR) during the study

  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 (2)

• Number of Participants with adverse events

  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)

  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

Study Arms (1)

MK-4827

EXPERIMENTAL

All Participants

Drug: MK-4827

Interventions

MK-4827 DRUG

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

MK-4827

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tesaro, Inc.: lead

MeSH Terms

Conditions

Lymphoma

Interventions

niraparib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 19, 2010
• Study Start: December 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 7, 2016

Record last verified: 2016-11