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

Lymphoma Clinical Trial

Official title:

A Phase II Efficacy Study of MK-4827 in Patients With Mantle Cell Lymphoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01244009
• Other study ID #: MK-4827-002
• Status: Withdrawn
• Phase: Phase 2
• First received: November 17, 2010
• Last updated: November 3, 2016
• Start date: December 2010
• Est. completion date: August 2013

Study information

• Verified date: November 2016
• Source: Tesaro, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle-Cell

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tesaro, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Participants with adverse events		From the day of enrollment through 30 days after the last dose of study drug	Yes
Secondary	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	No