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Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors

15. März 2011 aktualisiert von: Pfizer

A Phase IIIB, Randomized, Active Controlled Open-Label Study Of Sunitinib (Sutent) 37.5 Mg Daily Vs Imatinib Mesylate 800 Mg Daily In The Treatment Of Patients With Gastrointestinal Stromal Tumors (GIST) Who Have Had Progressive Disease While On 400 Mg Daily Of Imatinib

A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5 mg daily or imatinib 800 mg daily. This study will find out the benefits and potential side effects of taking sunitinib or imatinib for approximately one year.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The study prematurely discontinued on July 27, 2009 due to poor recruitment and operational futility as a result of changes in clinical practice. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

69

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Deutschland
      • Goettingen, Deutschland, 37075
        • Pfizer Investigational Site
      • Hamburg, Deutschland, 22767
        • Pfizer Investigational Site
  • Hongkong
      • Hong Kong, Hongkong
        • Pfizer Investigational Site
    • Kowloon
      • Lai Chi Kok, Kowloon, Hongkong
        • Pfizer Investigational Site
    • New Territories
      • Tuen Mun, New Territories, Hongkong
        • Pfizer Investigational Site
  • Italien
      • Bologna, Italien, 40138
        • Pfizer Investigational Site
      • Milano, Italien, 20133
        • Pfizer Investigational Site
      • San Giovanni Rotondo, Italien, 71013
        • Pfizer Investigational Site
  • Korea, Republik von
      • Seoul, Korea, Republik von, 138-736
        • Pfizer Investigational Site
      • Seoul, Korea, Republik von, 110-744
        • Pfizer Investigational Site
      • Seoul, Korea, Republik von, 135-710
        • Pfizer Investigational Site
  • Spanien
      • Barcelona, Spanien, 08036
        • Pfizer Investigational Site
      • Valencia, Spanien, 46009
        • Pfizer Investigational Site
  • Vereinigte Staaten
    • Michigan
      • Detroit, Michigan, Vereinigte Staaten, 48201
        • Pfizer Investigational Site
      • Farmington Hills, Michigan, Vereinigte Staaten, 48334
        • Pfizer Investigational Site
    • Missouri
      • Creve Coeur, Missouri, Vereinigte Staaten, 63141
        • Pfizer Investigational Site
      • St. Louis, Missouri, Vereinigte Staaten, 63110
        • Pfizer Investigational Site
      • St. Peters, Missouri, Vereinigte Staaten, 63376
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19111
        • Pfizer Investigational Site
  • Vereinigtes Königreich
      • Glasgow, Vereinigtes Königreich, G12 0YH
        • Pfizer Investigational Site
      • Leeds, Vereinigtes Königreich, LS9 7TF
        • Pfizer Investigational Site
      • London, Vereinigtes Königreich, SW3 6JJ
        • Pfizer Investigational Site
      • London, Vereinigtes Königreich, NW1 2PG
        • Pfizer Investigational Site
      • London, Vereinigtes Königreich, W1
        • Pfizer Investigational Site
      • Manchester, Vereinigtes Königreich, M20 4BX
        • Pfizer Investigational Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Patients with gastrointestinal stromal tumors whose disease has progressed on imatinib 400 mg daily.

Exclusion Criteria:

  • Current treatment with any chemotherapy other than imatinib.
  • Current treatment with any dose of imatinib other than 400 mg

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: B
Arzneimittel: imatinib mesylate
800mg daily
Experimental: EIN
Arzneimittel: sunitinib malate
37.5 mg daily
Andere Namen:
  • Sutent

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression-Free Survival (PFS)
Zeitfenster: Baseline, Week 5, and every 8 weeks until Year 2
Time from randomization to the first documentation of tumor progression or death due to any cause in the absence of documented tumor progression, whichever was earlier.
Baseline, Week 5, and every 8 weeks until Year 2

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival (OS)
Zeitfenster: Baseline up to 2 years
Time from date of randomization to the date of death. In the absence of confirmation of death, survival time was censored to the last date the participant was known to be alive.
Baseline up to 2 years
Time to Pain Relief Response (TTPR)
Zeitfenster: Day 28 of Cycle 1 up to 26
Pain relief response defined as a 50 percent (%) or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.
Day 28 of Cycle 1 up to 26
Time to Treatment Failure (TTF)
Zeitfenster: Day 28 of Cycle 1 up to 26
TTF included death for any reason, treatment termination due to intolerable toxicity, or withdrawal of consent, whichever occurred first.
Day 28 of Cycle 1 up to 26
Number of Participants With Objective Response of Complete Response or Partial Response
Zeitfenster: Day 28 of Cycle 1 up to 26
Number of participants with objective response based assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Day 28 of Cycle 1 up to 26
Time to Tumor Response (TTR)
Zeitfenster: Day 28 of Cycle 1 up to 26
Time from date of randomization to first documentation of objective tumor response (partial or complete response). Confirmed complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Day 28 of Cycle 1 up to 26
Duration of Response (DR)
Zeitfenster: Day 28 of Cycle 1 up to 26

Time from start of first documentation of objective response(complete or partial response) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause, whichever occurred first.

Confirmed complete response (CR) and partial response (PR)according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Day 28 of Cycle 1 up to 26
Time to Pain Progression (TTPP)
Zeitfenster: Day 28 of Cycle 1 up to 26
TTPP is the number of days from randomization to the first documentation of pain progression (defined as a 50% or more increase in MPQ-PPI score [0=no pain to 5=excruciating pain] or analgesic use from baseline for at least 3 consecutive weeks). Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.
Day 28 of Cycle 1 up to 26
Number of Participants With Pain Relief Response
Zeitfenster: Day 28 of Cycle 1 up to 26
Pain relief response defined as a 50% or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.
Day 28 of Cycle 1 up to 26
Number of Participants With Pain Progression
Zeitfenster: Day 28 of Cycle 1 up to 26
Pain progression defined as a 50% or more increase in MPQ-PPI score (0=no pain to 5=excruciating pain) or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.
Day 28 of Cycle 1 up to 26
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm
Zeitfenster: Days 1 and 28 of each cycle
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigned utility value for each domain in profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state.
Days 1 and 28 of each cycle
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm
Zeitfenster: Days 1 and 28 of each cycle
EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.
Days 1 and 28 of each cycle
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm
Zeitfenster: Days 1 and 28 of each cycle
EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigned utility value for each domain in the profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state.
Days 1 and 28 of each cycle
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm
Zeitfenster: Days 1 and 28 of each cycle
EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.
Days 1 and 28 of each cycle

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Pfizer

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2007

Primärer Abschluss (Tatsächlich)

1. November 2009

Studienabschluss (Tatsächlich)

1. November 2009

Studienanmeldedaten

Zuerst eingereicht

5. September 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. September 2006

Zuerst gepostet (Schätzen)

7. September 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

17. März 2011

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. März 2011

Zuletzt verifiziert

1. März 2011

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • A6181112

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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