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Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive and/or Progesterone Receptor Positive Her2 Negative Breast Cancer

11. april 2016 opdateret af: Merrimack Pharmaceuticals

A Randomized Double-Blind Phase 2 Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive (ER+) and/or Progesterone Receptor Positive (PR+) Her2 Negative Breast Cancer

To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer patients is more effective than Exemestane alone

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study is a double-blind, randomized Phase 2 trial of Exemestane +/- MM-121. The trial is designed to demonstrate whether MM-121 + Exemestane is more effective than Exemestane alone in ER+ and/or PR+ and Her2 negative breast cancer patients that have failed first-line anti-estrogen therapy in the locally advanced or metastatic setting and patients that have progressed during (or within 6 months of completing) adjuvant treatment with a non-steroidal aromatase inhibitor (AI)and/or tamoxifen. Patients will be treated until radiologic or clinical progression of their disease is documented. Local radiologist and/or PI assessment is accepted.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

118

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
      • Montreal, Canada, H4J 1C5
        • Hôpital du Sacré-Cœur de Montréal
      • Quebec, Canada, G1S 4L8
        • CHA St. Sacrement
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • McGill University Jewish General Hospital
      • Montreal, Quebec, Canada, H1T2M4
        • Hopital Maissoneuve-Rosemont
  • Den Russiske Føderation
      • Berezina, Den Russiske Føderation
        • Medico-Diagnostically Center of International Institution of biological systems n.a.S.M.
      • St. Petersburg, Den Russiske Føderation, 125271
        • Railway Clinical Hospital
      • St. Petersburg, Den Russiske Føderation, 188663
        • Leningrad Regional Oncology Center
      • St. Petersburg, Den Russiske Føderation, 197022
        • City Clinical Oncology Center
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35216
        • Achieve Clinical Research
      • Birmingham, Alabama, Forenede Stater, 35209
        • Achieve Clinical Research
    • Arizona
      • Glendale, Arizona, Forenede Stater, 85306
        • Arizona Center for Cancer Care
    • California
      • Anaheim, California, Forenede Stater, 92801
        • Pacific Cancer Medical Center
      • Beverly Hills, California, Forenede Stater, 90211
        • Beverly Hills Cancer Center
      • Corona, California, Forenede Stater, 92879
        • Wilshire Oncology Medical Group, Inc.
      • Escondido, California, Forenede Stater, 92025
        • Southwest Cancer Center
      • Oakland, California, Forenede Stater, 94609
        • Hematology Oncology Associates, Inc.
      • San Jose, California, Forenede Stater, 95124
        • San Jose Medical Center
      • Santa Maria, California, Forenede Stater, 93454
        • Central Coast Medical Oncology Corporation
    • Florida
      • New Port Richey, Florida, Forenede Stater, 34652
        • Pasco-Pinellas Oncology
      • Port St. Lucie, Florida, Forenede Stater, 34952
        • Hematology Oncology Associates of the Treasure Coast
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University Simon Cancer Center
      • Lafayette, Indiana, Forenede Stater, 47905
        • Horizon Oncology Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37909
        • Tennessee Cancer Specialists Oncology Clinical Trials Center for Biomedical Research
      • Knoxville, Tennessee, Forenede Stater, 37909
        • Tennessee Cancer Specialists, Oncology Clincial Trials Center for Biomedical Research
  • Spanien
      • Barcelona, Spanien, 8035
        • Vall d'Hebron University Hospital
      • Barcelona, Spanien, 8036
        • Hospital Clinic (Barcelona)
      • Barcelona, Spanien, 8208
        • Hospital Parc Tauli - Barcelona
      • Madrid, Spanien, 28007
        • Servicio de Oncología Médica / Hospital Universitario Gregorio Marañón
      • Madrid, Spanien, 28220
        • Puerta de Hierro
  • Tyskland
      • Munich, Tyskland, 80836
        • Onkogologisches zentrum Munich
      • Wiesbaden, Tyskland, 65189
        • Brustzentrum HS Kliniken Wiesbaden

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

Kvinde

Beskrivelse

Inclusion Criteria:

  • Locally advanced or metastatic breast cancer
  • Histologically or cytologically confirmed ER+ and/or PgR+ and Her2 negative breast cancer
  • ≥ 18 years of age

Exclusion Criteria:

  • Received prior treatment with exemestane
  • Extensive visceral disease (rapidly progressive, life-threatening metastases, including symptomatic lymphangitic metastases)
  • Symptomatic CNS disease

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: MM-121 (SAR256212) + exemestane
Medicin: MM-121
MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week
Andre navne:
  • SAR256212
Medicin: Exemestane
Exemestane (25 mg) administered orally once per day
Andre navne:
  • Aromasin
Placebo komparator: Placebo + exemestane
Medicin: Exemestane
Exemestane (25 mg) administered orally once per day
Andre navne:
  • Aromasin
Medicin: Placebo
Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week and exemestane (25 mg) administered orally once per day

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression Free Survival (PFS)
Tidsramme: Time from first dose to date of progression, the longest time frame of 79.1 weeks
To determine whether MM-121 + exemestane was more effective than placebo + exemestane in prolonging progression-free survival. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), "as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).
Time from first dose to date of progression, the longest time frame of 79.1 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival
Tidsramme: Time from first dose to date of death, over approximately 2 years
To determine whether MM-121 + exemestane is more effective than placebo + exemestane in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.
Time from first dose to date of death, over approximately 2 years

Samarbejdspartnere og efterforskere

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

Sponsor

Merrimack Pharmaceuticals

Efterforskere

  • Studieleder: Victor Moyo, MD, Merrimack Pharmaceuticals, Inc.

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

1. juni 2010

Primær færdiggørelse (Faktiske)

1. juni 2014

Studieafslutning (Faktiske)

1. september 2014

Datoer for studieregistrering

Først indsendt

24. juni 2010

Først indsendt, der opfyldte QC-kriterier

24. juni 2010

Først opslået (Skøn)

25. juni 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. maj 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. april 2016

Sidst verificeret

1. april 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MM-121-02-02-03 (ARD11588)

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 .

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