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

19. juni 2006 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding

80

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

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

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:

  • 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

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: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Samarbejdspartnere og efterforskere

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

Sponsor

Synta Pharmaceuticals Corp.

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. juli 2004

Studieafslutning

1. oktober 2005

Datoer for studieregistrering

Først indsendt

19. juli 2004

Først indsendt, der opfyldte QC-kriterier

22. juli 2004

Først opslået (Skøn)

23. juli 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. juni 2006

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juni 2006

Sidst verificeret

1. juni 2006

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 4783-04

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 Blødt vævssarkom

Kliniske forsøg med STA-4783

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Jordan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner