Study of MK-8808 for Participants With Follicular Lymphoma (MK-8808-001)

NCT ID: NCT01370694

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-19
• Study Completion Date: 2014-12-01

Brief Summary

This study will evaluate the safety, pharmacokinetics, and anti-tumor activity of MK-8808 in combination with cyclophosphamide, vincristine, and prednisolone (CVP), and as a single agent, for participants with B-lymphocyte antigen cluster of differentiation 20 (CD20)-positive follicular lymphoma who have had no prior chemotherapy. The primary study hypothesis is that MK-8808 will be safe and well tolerated in combination with CVP and as a single agent.

Detailed Description

The study was terminated early by the Sponsor due to business reasons. All participants were discontinued from MK-8808 + CVP, but could continue to receive maintenance therapy with MabThera™ (rituximab) per standard of care.

Conditions

Follicular Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MK-8808 Combination Therapy

Participants received MK-8808 375 mg/m\^2 intravenously (IV) + cyclophosphamide 750 mg/m\^2 IV + vincristine 1.4 mg/m\^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m\^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m\^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.

Group Type: EXPERIMENTAL

MK-8808

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

vincristine

Intervention Type: DRUG

prednisolone

Intervention Type: DRUG

Interventions

MK-8808

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

vincristine

Intervention Type: DRUG

prednisolone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histological diagnosis of CD20-positive follicular lymphoma, Grade 1, 2, or 3a (World Health Organization [WHO] 2008 classification) based on an excisional or incisional lymph node biopsy or a bone marrow biopsy.
• Ann Arbor Stage III or IV disease.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
• Life expectancy >3 months with no expected need of immediate intervention to treat life-threatening complications.
• Adequate organ function.
• Participants must agree to use an adequate method of contraception starting with the first dose of study drug through 12 months (for females) or 90 days (for males) after the last dose of study drug.

Exclusion Criteria

• Histological Grade 3b or with >50% diffuse architectural pattern.
• Circulating malignant cells >25,000/mm^3
• Presence or history of central nervous system (CNS) disease (either CNS lymphoma or lymphomatous meningitis).
• Prior treatment with chemotherapy, rituximab, any other anti-CD20 compound, or any other type of anti-cancer compounds.
• Radiotherapy within 2 months prior to Cycle 1 Day 1.
• Current participation or has participated in a study with an investigational compound within 30 days prior to Cycle 1 Day 1.
• Concomitant disease that requires continuous therapy with prednisone at doses >20 mg per day.
• Any medical contraindication for prednisolone as being dosed in the CVP regimen.
• Poorly controlled diabetes mellitus, as defined by institutional or local standards.
• Grade >2 peripheral neuropathy.
• Has one of the following:

1. is human immunodeficiency virus (HIV)-positive

2. is Hepatitis B surface antigen positive (HBsAg+) or is positive for antibodies to Hepatitis B core antigen (anti-HBcAg+)

3. has antibodies to Hepatitis C virus

• Has one or more of the following:

1. Active tuberculosis based on institutional diagnostic criteria and local practice guidelines.

2. Evidence of a tuberculosis infection based on a chest X-ray (CXR) or computed tomography (CT) scan performed within 3 months of dosing.

3. History of a tuberculosis infection.

• Major surgical procedure within 4 weeks prior to Cycle 1 Day 1.
• Regular use (including "recreational" use) of any illicit drugs or recent history (within the last year) of drug or alcohol abuse or dependence.
• Pregnant or breastfeeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

Document Type: CSR Synopsis Link

View Document

Other Identifiers

2011-000386-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

8808-001

Identifier Type: -

Identifier Source: org_study_id