- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01370694
Study of MK-8808 for Participants With Follicular Lymphoma (MK-8808-001)
February 28, 2019 updated by: Merck Sharp & Dohme LLC
An Open-Label, Single Arm Study of MK-8808 in Patients With Advanced CD20-Positive Follicular Lymphoma
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- is human immunodeficiency virus (HIV)-positive
- is Hepatitis B surface antigen positive (HBsAg+) or is positive for antibodies to Hepatitis B core antigen (anti-HBcAg+)
- has antibodies to Hepatitis C virus
Has one or more of the following:
- Active tuberculosis based on institutional diagnostic criteria and local practice guidelines.
- Evidence of a tuberculosis infection based on a chest X-ray (CXR) or computed tomography (CT) scan performed within 3 months of dosing.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy
Time Frame: From first dose of combination therapy up to 24 weeks
|
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
|
Number of Participants Experiencing Clinical and Laboratory AEs During MK-8808 Maintenance Therapy
Time Frame: From first dose of single agent MK-8808 up to 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Concentration (Cmax) of Plasma Levels of MK-8808 When Used in Combination With CVP
Time Frame: Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)
|
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)
|
Cmax of Plasma Levels of MK-8808 During Single Agent Maintenance Therapy
Time Frame: Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)
|
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)
|
Lowest Concentration (Ctrough) of Plasma Levels of MK-8808 When Used in Combination With CVP
Time Frame: Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)
|
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)
|
Ctrough of Plasma Levels of MK-8808 When Used as Single Agent Maintenance
Time Frame: Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)
|
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)
|
Clinical Response of Tumor to MK-8808/CVP Combination Therapy
Time Frame: Up to 2 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 19, 2011
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
May 18, 2011
First Submitted That Met QC Criteria
June 9, 2011
First Posted (Estimate)
June 10, 2011
Study Record Updates
Last Update Posted (Actual)
March 15, 2019
Last Update Submitted That Met QC Criteria
February 28, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Follicular
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Prednisolone
- Cyclophosphamide
- Vincristine
Other Study ID Numbers
- 8808-001
- 2011-000386-13 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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