Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

A Study of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Soft Tissue Sarcomas

19. juni 2006 oppdatert av: Synta Pharmaceuticals Corp.
The purpose of this study is to evaluate the safety and effectiveness of an experimental study drug (STA-4783) combined with an approved cancer medicine, paclitaxel, in the treatment of soft tissue sarcomas. Paclitaxel (Taxol®) has been approved and used in the United States since 1992.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

STA-4783 is a taxane potentiator, enhancing the effect of antitumor response of paclitaxel. In an attempt to improve efficacy, paclitaxel is sometimes used in combination with other anticancer agents. When paclitaxel is combined with other anticancer agents, although response rate is usually increased, side effects are usually increased as well. There is an urgent need for agents that can enhance the antitumor effects of paclitaxel without further increasing undesirable side effects.

Studietype

Intervensjonell

Registrering

80

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
  • Forente stater
    • Arizona
      • Scottsdale, Arizona, Forente stater, 85258
        • Arizona Cancer Center
      • Tucson, Arizona, Forente stater, 85724
        • Arizona Cancer Center
    • California
      • Los Angeles, California, Forente stater, 90095
        • UCLA
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06520
        • Yale University School Of Medicine
    • Florida
      • Gainesville, Florida, Forente stater, 32610
        • University of Florida
      • Tampa, Florida, Forente stater, 33612
        • H. Lee Moffitt Cancer Center
      • West Palm Beach, Florida, Forente stater, 33401
        • Palm Beach Cancer Institute
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Winship Cancer Institute
    • Illinois
      • Chicago, Illinois, Forente stater, 60637
        • University of Chicago Department of Medicine
    • Kansas
      • Wichita, Kansas, Forente stater, 67214
        • Via Christi Regional Med. Center (Wichita CCOP)
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40202
        • University of Louisville Hospital
    • Louisiana
      • Shreveport, Louisiana, Forente stater, 71103
        • Feist-Weiller Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Dana-Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan
      • Detroit, Michigan, Forente stater, 48201
        • Wayne State University
      • Flint, Michigan, Forente stater, 48503
        • Genesys Hurley Cancer Institute
    • Missouri
      • St. Louis, Missouri, Forente stater, 63110
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68198
        • University of Nebraska Medical Center
    • New York
      • New York, New York, Forente stater, 10016
        • NYU Cancer Institute Clinical Center
      • New York, New York, Forente stater, 10032
        • Herbert Irving Cancer Center
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28203
        • Carolinas Medical Center/Blumenthal Cancer Center
    • Oregon
      • Portland, Oregon, Forente stater, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Pittsburg, Pennsylvania, Forente stater, 15232
        • Hillman Cancer Center
    • Tennessee
      • Memphis, Tennessee, Forente stater, 38120
        • The West Clinic
      • Nashville, Tennessee, Forente stater, 37203
        • The Sarah Cannon Cancer Center
    • Texas
      • Houston, Texas, Forente stater, 77030
        • MD Anderson Cancer Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Must be 18 years of age or older with histologic diagnosis of soft tissue sarcoma
  • Must have disease not suitable for curative resection
  • Must have failed >1 first line treatment with evidence of progression. Adjuvant therapy does not count as 1st line therapy unless recurrence occurs within 6 months of administration
  • Must have ability to understand and the willingness to sign a written informed consent document
  • Must have Eastern Cooperative Oncology Group (ECOG) performance status of < 2
  • Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • At least 4 weeks have passed since the last chemotherapy, immunotherapy, or radiation therapy
  • There must be measurable disease outside the radiotherapy fields or progression of the indicator lesions within the field since the completion of the radiotherapy
  • Must have a life expectancy of greater than 12 weeks
  • Must have clinical laboratory values at screening as defined below:
  • Hemoglobin >9 g/dL,
  • Absolute neutrophil count >1500/mm3,
  • Platelet count >100,000/mm3,
  • Creatinine <1.5 X ULN,
  • Bilirubin <1.5 X ULN,
  • Asparate aminotransferase and alanine aminotransferase <2.5 X ULN (<5 X ULN in presence of liver metastases)

Exclusion Criteria:

  • Female patients who are pregnant or breast feeding
  • Patients of childbearing potential not using or not willing to use a barrier method of contraception

  • Prior malignancy other than soft tissue sarcoma (STS) within the last 5 yrs with the exception of:

    • Adequately treated in situ carcinoma of the cervix uteri;
    • Basal or squamous cell carcinoma of the skin
  • Presence of a clinically significant and uncontrolled infection
  • Presence of >Grade 2 neuropathy
  • Symptomatic central nervous system metastases within last 8 weeks or on corticosteroids for CNS symptom management
  • Presence of clinically significant arrythmias
  • Presence of a serious concurrent illness or other conditions (e.g., psychological, family, sociological, or geographical circumstances) that do not permit adequate follow-up and compliance with the protocol
  • History of severe hypersensitivity reactions to taxanes or cremaphore in spite of premedication
  • Use of any investigational agents within 4 weeks prior to the first dose of study drug(s)
  • Major surgery within 2 weeks of screening
  • Radiation treatment in past >25% of bone marrow

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Synta Pharmaceuticals Corp.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2004

Studiet fullført

1. oktober 2005

Datoer for studieregistrering

Først innsendt

19. juli 2004

Først innsendt som oppfylte QC-kriteriene

22. juli 2004

Først lagt ut (Anslag)

23. juli 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

20. juni 2006

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. juni 2006

Sist bekreftet

1. juni 2006

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 4783-04

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere