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Follicular LymphomaPhase 1NCT01370694

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

A Phase 1 study testing MK-8808, cyclophosphamide and vincristine in people with Follicular Lymphoma, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
MK-8808, cyclophosphamide and vincristine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
No sites listed yet
Study dates
19 Aug 2011to 1 Dec 2014
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

About this study

Official title: 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.

Read the 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.

Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01370694
Study groupRoleWhat they receive
MK-8808 Combination TherapyExperimentalParticipants 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.
Receives: Drug: MK-8808; Drug: cyclophosphamide; Drug: vincristine; Drug: prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From first dose of combination therapy up to 24 weeks

  2. 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.

    Measured: From first dose of single agent MK-8808 up to 2 years

Secondary outcomes (5)

  1. 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.

    Measured: Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)

  2. 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.

    Measured: Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)

  3. 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.

    Measured: Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)

  4. 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.

    Measured: Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)

  5. 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.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2011 (estimated)
  2. Study start19 Aug 2011
  3. Primary completion1 Dec 2014
  4. Study completion1 Dec 2014

Why it stopped: The study was terminated for business reasons.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01370694
Sponsor's protocol ID
8808-001
Other IDs
2011-000386-13
Status last verified
Feb 2019
First submitted
18 May 2011
Last updated
15 Mar 2019
Data monitoring committee
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-8808, cyclophosphamide and vincristine in people with Follicular Lymphoma, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01370694.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.

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