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

16 februari 2022 uppdaterad 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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

11

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Paklitaxel
Läkemedel: Paclitaxel
Solution, I.V., 100 mg/m2 Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent
Andra namn:
  • Taxol
  • BMS-181339

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With SAEs
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Best Overall Response Per RECIST Criteria
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Bristol-Myers Squibb

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

4 augusti 2006

Primärt slutförande (Faktisk)

26 november 2008

Avslutad studie (Faktisk)

26 november 2008

Studieregistreringsdatum

Först inskickad

3 september 2009

Först inskickad som uppfyllde QC-kriterierna

3 september 2009

Första postat (Uppskatta)

4 september 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 april 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 februari 2022

Senast verifierad

1 februari 2022

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CA139-539

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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