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

28. februar 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

7

Fase

  • Fase 1

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: cyclophosphamid
Medicin: prednisolon
Medicin: vincristine
Medicin: MK-8808

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum Concentration (Cmax) of Plasma Levels of MK-8808 When Used in Combination With CVP
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Merck Sharp & Dohme LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. august 2011

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

18. maj 2011

Først indsendt, der opfyldte QC-kriterier

9. juni 2011

Først opslået (Skøn)

10. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 8808-001
  • 2011-000386-13 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Studiedata/dokumenter

  1. CSR Synopsis Link

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Follikulært lymfom

Kliniske forsøg med cyclophosphamid

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Switzerland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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