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

Phase 2

Withdrawn

• Conditions: Lymphoma; Mantle-Cell
• Interventions: Drug: MK-4827

• Registration Number: NCT01244009
• Lead Sponsor: Tesaro, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-17
• Study First Submitted QC: 2010-11-17
• Study First Posted: 2010-11-19
• Study Start: 2010-12
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-11-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MK-4827	MK-4827	All Participants

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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