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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01370694
First received: May 18, 2011
Last updated: February 10, 2014
Last verified: February 2014

May 18, 2011
February 10, 2014
August 2011
December 2014   (final data collection date for primary outcome measure)
  • Number of participants experiencing clinical and laboratory adverse events (AEs) during combination therapy [ Time Frame: From first dose (baseline) of CVP therapy up to 30 days post last dose (up to eight 21-day cycles of combination therapy) ] [ Designated as safety issue: Yes ]
  • Number of participants experiencing clinical and laboratory AEs during single agent maintenance with MK-8808 [ Time Frame: From first dose (baseline) of single agent maintenance therapy up to 30 days after the last dose (up to 2 years) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01370694 on ClinicalTrials.gov Archive Site
  • Maximum concentration (C[max]) in plasma levels of MK-8808 when used in combination with CVP [ Time Frame: Day 1 of all CVP cycles (up to eight 21-day cycles) ] [ Designated as safety issue: No ]
  • C[max] in plasma levels of MK-8808 when used as single agent maintenance [ Time Frame: Day 1 of every other bimonthly single agent maintenance therapy cycle; or Day 1 of each 6-month single agent maintenance cycle, up to 2 years ] [ Designated as safety issue: No ]
  • Lowest concentration (C[trough]) of plasma levels of MK-8808 when used in combination with CVP [ Time Frame: Day 1 of all CVP cycles (up to eight 21-day cycles) ] [ Designated as safety issue: No ]
  • C[trough] of plasma levels of MK-8808 when used as single agent maintenance [ Time Frame: Day 1 of every other bimonthly single agent maintenance therapy cycle; or Day 1 of each 6-month single agent maintenance cycle, up to 2 years ] [ Designated as safety issue: No ]
  • Clinical response [ Time Frame: Before each cycle of CVP (baseline), every 3 to 4 months during maintenance therapy, and approximately one month after last dose of MK-8808, up to 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of MK-8808 for Participants With Follicular Lymphoma (MK-8808-001)
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Follicular Lymphoma
  • Drug: MK-8808
    Intravenous (IV) infusion at a dose of 375 mg/m^2 on Day 1 of each 21-day combination therapy cycle; at 375 mg/m^2 administered approximately every 2 months for up to 2 years, beginning 8 weeks (2 months) afer the last dose of induction therapy.
  • Drug: cyclophosphamide
    IV infusion, 750 mg/m^2, on Day 1 of each 21-day combination therapy cycle
  • Drug: vincristine
    IV infusion, 1.4 mg/m^2 (max 2 mg), on Day 1 of each 21-day combination therapy cycle
  • Drug: prednisolone
    40 mg/m^2,orally, on Days 1-5 of each 21-day combination therapy cycle
  • Experimental: MK-8808 Combination therapy
    Interventions:
    • Drug: MK-8808
    • Drug: cyclophosphamide
    • Drug: vincristine
    • Drug: prednisolone
  • Experimental: MK-8808 Maintenance therapy (2 month cycle)
    Intervention: Drug: MK-8808
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
22
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01370694
8808-001, 2011-000386-13
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP