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Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer

16. februar 2022 oppdatert av: Bristol-Myers Squibb
The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator, and to evaluate the frequency and the severity of observed adverse reactions in treated subjects

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

11

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Japan
      • Kanagawa, Japan
        • Local Institution
      • Tochigi, Japan, 329-0498
        • Local Institution
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 2778577
        • Local Institution
    • Ehime
      • Matsuyama-shi, Ehime, Japan
        • Local Institution
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 8900075
        • Local Institution
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-0815
        • Local Institution
    • Osaka
      • Osaka-shi, Osaka, Japan, 5458586
        • Local Institution
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 4118777
        • Local Institution
    • Tokyo
      • Meguro-ku, Tokyo, Japan, 1520021
        • Local Institution

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

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Paklitaksel
Legemiddel: Paclitaxel
Solution, I.V., 100 mg/m2 Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent
Andre navn:
  • Taxol
  • BMS-181339

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With SAEs
Tidsramme: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants with SAEs
From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants With Adverse Events Leading to Discontinuation
Tidsramme: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants with Adverse Events Leading to Discontinuation
From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants With Adverse Events
Tidsramme: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants with Adverse Events
From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants With Laboratory Abnormalities
Tidsramme: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants with Laboratory Abnormalities
From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants With Drug Related Laboratory Abnormalities
Tidsramme: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants with Drug Related Laboratory Abnormalities
From the first infusion to the completion of study. Approximately up to 28 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Best Overall Response Per RECIST Criteria
Tidsramme: From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
Best overall response is represented by the number participants who have had complete response, partial response and have stable disease.
From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
Number of Participants With Best Overall Response Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer
Tidsramme: From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
Best overall response is represented by the number participants who have had complete response, partial response and not completed.
From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
Duration of Overall Response as Per RECIST Criteria
Tidsramme: From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
DOR is defined as the median time from the first date of Partial Response to the first date of Progressive Disease. Participants were evaluated for DOR in a separate study (NCT00971867).
From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
Duration of Overall Response as Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer
Tidsramme: From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
Best overall response is represented by the number participants who have had complete response, partial response and not completed.
From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months

Samarbeidspartnere og etterforskere

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

Sponsor

Bristol-Myers Squibb

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 (Faktiske)

4. august 2006

Primær fullføring (Faktiske)

26. november 2008

Studiet fullført (Faktiske)

26. november 2008

Datoer for studieregistrering

Først innsendt

3. september 2009

Først innsendt som oppfylte QC-kriteriene

3. september 2009

Først lagt ut (Anslag)

4. september 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. april 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. februar 2022

Sist bekreftet

1. februar 2022

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CA139-539

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. .

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Sponsorer og samarbeidspartnere

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Legemiddelintervensjoner

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Forhold

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Legemiddelintervensjoner

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Sponsor / samarbeidspartnere

Steder

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