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

Follicular Lymphoma Clinical Trial

Official title:

An Open-Label, Single Arm Study of MK-8808 in Patients With Advanced CD20-Positive Follicular Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01370694
• Other study ID #: 8808-001
• Secondary ID: 2011-000386-13
• Status: Terminated
• Phase: Phase 1
• Start date: August 19, 2011
• Est. completion date: December 1, 2014

Study information

• Verified date: February 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 1, 2014
• Est. primary completion date: December 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• MK-8808

• cyclophosphamide

• vincristine

• prednisolone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy	An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.	From first dose of combination therapy up to 24 weeks
Primary	Number of Participants Experiencing Clinical and Laboratory AEs During MK-8808 Maintenance Therapy	An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.	From first dose of single agent MK-8808 up to 2 years
Secondary	Maximum Concentration (Cmax) of Plasma Levels of MK-8808 When Used in Combination With CVP	Cmax is a measure of the maximum concentration of the drug in the plasma as measured using plasma samples taken over specified time points.	Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)
Secondary	Cmax of Plasma Levels of MK-8808 During Single Agent Maintenance Therapy	Cmax is a measure of the maximum amount of drug in the plasma over time using samples taken at specified time points.	Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)
Secondary	Lowest Concentration (Ctrough) of Plasma Levels of MK-8808 When Used in Combination With CVP	Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.	Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)
Secondary	Ctrough of Plasma Levels of MK-8808 When Used as Single Agent Maintenance	Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.	Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)
Secondary	Clinical Response of Tumor to MK-8808/CVP Combination Therapy	The response of the tumor to MK-8808/CVP combination therapy was radiographically assessed using Response Criteria Evaluation in Solid Tumors (RECIST). Response categories of partial response (PR), complete resonse (CR), and uncomfirmed (CRu) central review.	Up to 2 years