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

NCT01370694 | Terminated Phase 1 Results

• 2 other identifiers: 8808-0012011-000386-13
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Maximum Concentration (Cmax) of Plasma Levels of MK-8808 When Used in Combination With CVP

  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

  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

  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

  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

  Up to 2 years

Study Arms (1)

MK-8808 Combination Therapy

EXPERIMENTAL

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.

Drug: MK-8808; Drug: cyclophosphamide; Drug: vincristine; Drug: prednisolone

Interventions

MK-8808 DRUG

MK-8808 Combination Therapy

cyclophosphamide DRUG

MK-8808 Combination Therapy

vincristine DRUG

MK-8808 Combination Therapy

prednisolone DRUG

MK-8808 Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Cyclophosphamide; Vincristine; Prednisolone

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

The study was terminated for business reasons. Not all planned analyses were performed

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: June 10, 2011
• Study Start: August 19, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 15, 2019
• Results First Posted: November 25, 2015

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share