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A Phase II Study of CI-1033 in Treating Patients With Metastatic (Stage IV) Breast Cancer

3. maj 2007 opdateret af: Pfizer

A Phase II, Randomized, Open-Label Study of Single Agent CI-1033 in Patients With Metastatic Breast Cancer

CI-1033 is an experimental drug that acts as an inhibitor of erbB (EGFR) receptors, which may be involved in tumor growth. The primary objective of this study is to assess the antitumor activity of CI-1033 in patients with metastatic breast cancer. Patients with histologically confirmed metastatic (Stage IV) breast cancer and who have received no more than 2 prior cytotoxic chemotherapy regimens are eligible for this study. CI-1033 is administered orally. Patients are required to have blood tests periodically while receiving treatment and will be closely monitored throughout the study for possible side effects and response to treatment. Patients may not have received any prior treatment with other agents that target erbB receptors, including Herceptin (trastuzumab) or Iressa (gefitinib).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

168

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Brussels, Belgien, 1070
        • Pfizer Investigational Site
      • Brussels, Belgien, 1000
        • Pfizer Investigational Site
      • Leuven, Belgien, 3000
        • Pfizer Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Pfizer Investigational Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H2L 4M1
        • Pfizer Investigational Site
  • Det Forenede Kongerige
      • Glasgow, Det Forenede Kongerige, G11 6NT
        • Pfizer Investigational Site
      • London, Det Forenede Kongerige, SE1 9RT
        • Pfizer Investigational Site
      • London, Det Forenede Kongerige, SW3 6JJ
        • Pfizer Investigational Site
    • Surrey
      • Sutton, Surrey, Det Forenede Kongerige, SM2 5PT
        • Pfizer Investigational Site
  • Forenede Stater
    • Alabama
      • Montgomery, Alabama, Forenede Stater, 36106
        • Pfizer Investigational Site
    • California
      • Arroyo Grande, California, Forenede Stater, 93420
        • Pfizer Investigational Site
      • Montebello, California, Forenede Stater, 90640
        • Pfizer Investigational Site
      • San Francisco, California, Forenede Stater, 94115
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80010
        • Pfizer Investigational Site
    • Florida
      • Aventura, Florida, Forenede Stater, 33180
        • Pfizer Investigational Site
      • Miami Beach, Florida, Forenede Stater, 33140
        • Pfizer Investigational Site
      • Plantation, Florida, Forenede Stater, 33324
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637-1470
        • Pfizer Investigational Site
      • Maywood, Illinois, Forenede Stater, 60153
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66112
        • Pfizer Investigational Site
      • Lenexa, Kansas, Forenede Stater, 66214
        • Pfizer Investigational Site
      • Overland Park, Kansas, Forenede Stater, 66210
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Pfizer Investigational Site
      • Boston, Massachusetts, Forenede Stater, 02115
        • Pfizer Investigational Site
      • Boston, Massachusetts, Forenede Stater, 02215
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-0922
        • Pfizer Investigational Site
      • Brownstown, Michigan, Forenede Stater, 48183
        • Pfizer Investigational Site
      • Dearborn, Michigan, Forenede Stater, 48126
        • Pfizer Investigational Site
      • Detroit, Michigan, Forenede Stater, 48202
        • Pfizer Investigational Site
      • West Bloomfield, Michigan, Forenede Stater, 48322
        • Pfizer Investigational Site
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • Pfizer Investigational Site
      • Kansas City, Missouri, Forenede Stater, 64131
        • Pfizer Investigational Site
      • Kansas City, Missouri, Forenede Stater, 64154
        • Pfizer Investigational Site
      • Lee's Summit, Missouri, Forenede Stater, 64064
        • Pfizer Investigational Site
    • New York
      • Bronx, New York, Forenede Stater, 10461
        • Pfizer Investigational Site
      • Bronx, New York, Forenede Stater, 10467
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Pfizer Investigational Site
    • Tennessee
      • Gallatin, Tennessee, Forenede Stater, 37066
        • Pfizer Investigational Site
      • Hermitage, Tennessee, Forenede Stater, 37076
        • Pfizer Investigational Site
      • Lebanon, Tennessee, Forenede Stater, 37087
        • Pfizer Investigational Site
      • Murfreesboro, Tennessee, Forenede Stater, 37130
        • Pfizer Investigational Site
      • Nashville, Tennessee, Forenede Stater, 37203
        • Pfizer Investigational Site
      • Nashville, Tennessee, Forenede Stater, 37205
        • Pfizer Investigational Site
      • Nashville, Tennessee, Forenede Stater, 37207
        • Pfizer Investigational Site
      • Nashville, Tennessee, Forenede Stater, 37211
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, Forenede Stater, 75246
        • Pfizer Investigational Site
      • Houston, Texas, Forenede Stater, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Pfizer Investigational Site
    • Washington
      • Walla Walla, Washington, Forenede Stater, 99362
        • Pfizer Investigational Site
  • Frankrig
      • Avignon Cedex 2, Frankrig, 84082
        • Pfizer Investigational Site
      • Paris Cedex 05, Frankrig, 75248
        • Pfizer Investigational Site
      • Paris Cedex 13, Frankrig, 75651
        • Pfizer Investigational Site
  • Irland
      • Dublin 8, Irland
        • Pfizer Investigational Site
      • Galway, Irland
        • Pfizer Investigational Site
  • Italien
      • Bologna, Italien, 40139
        • Pfizer Investigational Site
      • Forli', Italien, 47100
        • Pfizer Investigational Site
      • Modena, Italien, 41100
        • Pfizer Investigational Site
      • Roma, Italien, 00144
        • Pfizer Investigational Site
  • Spanien
      • Madrid, Spanien, 28041
        • Pfizer Investigational Site
      • Madrid, Spanien, 28040
        • Pfizer Investigational Site
  • Sverige
      • Stockholm, Sverige, 118 83
        • Pfizer Investigational Site
      • Stockholm, Sverige, 17176
        • Pfizer Investigational Site

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:

  • Female, at least 18 years of age
  • Histologically confirmed diagnosis of breast cancer
  • Metastatic (Stage IV) disease
  • Progressive or recurrent disease following the most recent therapy
  • No more than 2 different, prior cytotoxic chemotherapy regimens for metastatic disease
  • At least one measurable target lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) that has not been irradiated
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, determined within 2 weeks prior to randomization
  • Estimated life expectancy of > 12 weeks
  • Capable of giving written informed consent
  • Capable of swallowing intact CI-1033 capsules
  • Capable of understanding and adhering to the protocol requirements
  • No prior exposure to CI-1033 or other agents that target the erbB receptor family (such as Herceptin, Iressa, Tarceva, IMC-C225, and EKB-569)
  • No known hypersensitivity reaction to tyrosine kinase inhibitors
  • Adequate liver, renal, or bone marrow function determined within 2 weeks prior to randomization
  • No cytotoxic chemotherapy within 3 weeks prior to baseline disease assessments (6 weeks for nitrosoureas or mitomycin)
  • No immunotherapy (including Herceptin) or other biologic therapy within 2 weeks prior to baseline disease assessments
  • No hormone therapy (including hormone replacement therapy) within 4 weeks prior to baseline disease assessments (6 weeks for megestrol acetate)
  • Patients must have recovered from the acute effects of any radiation therapy or surgery
  • No treatment with any other investigational therapy within 4 weeks prior to baseline disease assessments
  • No history of any cancer other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix) within the last 5 years
  • No patients with untreated brain metastases or patients that have not recovered from treatment for brain metastases
  • No known malabsorption syndrome or other condition that may impair absorption of study medication
  • No comorbidity or condition which compromises compliance with this protocol as judged by the investigator or that would significantly complicate interpretation of the safety profile of CI-1033
  • No patients having reproductive potential who are not using a method of birth control or who are pregnant or breastfeeding or have a positive pregnancy test during baseline

Exclusion Criteria:

Prior exposure to CI-1033 or other agents that target the erbB receptor family; cytotoxic chemotherapy within 3 weeks prior to baseline disease assessments (6 weeks for nitrosoureas or mitomycin); immunotherapy (including Herceptin) or other biologic therapy within 2 weeks prior to baseline disease assessments; hormone therapy (including hormone replacement therapy) within 4 weeks prior to baseline disease assessments; 6 weeks for megestrol acetate (to exclude the possibility of a hormone-withdrawal response); patients with untreated brain metastases.

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: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
The primary objective is to assess the antitumor activity of CI 1033 in patients with metastatic breast cancer.

Sekundære resultatmål

Resultatmål
Secondary objectives include an assessment of safety and patient reported outcomes (eg, quality of life [QOL])
correlations between erbB expression and efficacy
exploratory analyses of soluble erbB-2 or other biomarkers
exploratory questions to measure the patient-reported impact of diarrhea and skin reactions will also be assessed

Samarbejdspartnere og efterforskere

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

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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. december 2002

Studieafslutning (Faktiske)

1. maj 2005

Datoer for studieregistrering

Først indsendt

2. januar 2003

Først indsendt, der opfyldte QC-kriterier

2. januar 2003

Først opslået (Skøn)

3. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. maj 2007

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. maj 2007

Sidst verificeret

1. september 2006

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1033-011

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 .

Abonner