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AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer

22. April 2019 aktualisiert von: Pfizer

A RANDOMIZED PHASE 2 STUDY OF THE ANTI-ANGIOGENESIS AGENT AG-013736 IN COMBINATION WITH GEMCITABINE IN PATIENTS WITH CHEMOTHERAPY-NAIVE ADVANCED PANCREATIC CANCER PRECEDED BY A PHASE 1 PORTION

This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib [AG-013736] in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

111

Phase

  • Phase 2

Kontakte und Standorte

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

Studienorte

  • Belgien
      • Gent, Belgien, 9000
        • Universitair Ziekenhuis Gent/Dienst Gastroenterologie
  • Deutschland
      • Berlin, Deutschland, 13353
        • Medizinische Klinik mit Schwerpunkt Haematologie und Onkologie, Charité-Universitaetsmedizin Berlin
  • Frankreich
      • Marseille, Frankreich, 13005
        • Hôpital La Timone
      • Paris Cedex 13, Frankreich, 75651
        • Hopital de La Pitie Salpetriere
      • Toulouse, Frankreich, 31052
        • Institut Claudius Regaud
    • Saint Herblain Cedex
      • Saint-Herblain, Saint Herblain Cedex, Frankreich, 44805
        • Service Oncologie Medicale
  • Italien
      • Milano, Italien, 20133
        • Fondazione IRCCS, Istituto Nazionale Tumori, Oncologia Medica B
      • Roma, Italien, 00168
        • Unita Operativa, Oncologia Medica, Istituto di Medicina Interna e Geriatria
  • Kanada
    • Alberta
      • Edmonton, Alberta, Kanada, T6G 1Z2
        • Cross Cancer Institute
    • Manitoba
      • Winnipeg, Manitoba, Kanada, R3E 0V9
        • CancerCare Manitoba
      • Winnipeg, Manitoba, Kanada, R2H 2A6
        • Cancer Care Manitoba
    • Ontario
      • Sault Ste Marie, Ontario, Kanada, P6A 2C4
        • Sault Area Hospital
      • Toronto, Ontario, Kanada, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Kanada, H2X 3J4
        • CHUM, Hopital Saint-Luc
  • Spanien
      • Barcelona, Spanien, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spanien, 08035
        • Hospital Universitario Vall d´Hebron
      • Sevilla, Spanien, 41013
        • Hospital Universitario Virgen Del Rocio
  • Vereinigte Staaten
    • California
      • Antioch, California, Vereinigte Staaten, 94509
        • East Bay Medical Oncology/Hematology Medical Associates Inc.
      • Berkeley, California, Vereinigte Staaten, 94704
        • Alta Bates Comprehensive Cancer Center
      • Concord, California, Vereinigte Staaten, 94520
        • Bay Area Cancer Research Group
      • Concord, California, Vereinigte Staaten, 94520
        • East Bay Medical Oncology/Hematology Medical Associates, Inc.
    • Connecticut
      • Stamford, Connecticut, Vereinigte Staaten, 06902-3628
        • Hematology Oncology, P.C.
    • Florida
      • Miami, Florida, Vereinigte Staaten, 33136
        • University of Miami Hospital & Clinics
      • Miami, Florida, Vereinigte Staaten, 33136
        • Jackson Memorial Hospital & Clinics
      • Tampa, Florida, Vereinigte Staaten, 33612-9497
        • H Lee Moffitt Cancer Center & Research Institute
    • Maine
      • Biddeford, Maine, Vereinigte Staaten, 04005
        • Maine Center for Cancer Medicine and Blood Disorders
      • Brunswick, Maine, Vereinigte Staaten, 04011
        • Maine Center for Cancer Medicine and Blood Disorders
      • Scarborough, Maine, Vereinigte Staaten, 04074
        • Maine Center for Cancer Medicine and Blood Disorders
    • Missouri
      • Saint Louis, Missouri, Vereinigte Staaten, 63141
        • Arch Medical Services, Inc. d/b/a The Center for Cancer Care and Research
      • Washington, Missouri, Vereinigte Staaten, 63090
        • Arch Medical Services, Inc. d/b/a The Center for Cancer Care and Research
    • Nebraska
      • Lincoln, Nebraska, Vereinigte Staaten, 68510
        • Southeast Nebraska Cancer Center, Southeast Nebraska Hematology and Oncology Consultants, P.C.
    • North Carolina
      • Winston-Salem, North Carolina, Vereinigte Staaten, 27103
        • Piedmont Hematology Oncology Association
      • Winston-Salem, North Carolina, Vereinigte Staaten, 27292
        • Piedmont Hematology Oncology Associates
    • Wisconsin
      • Madison, Wisconsin, Vereinigte Staaten, 53792
        • University of Wisconsin Hospital and Clinics
  • Vereinigtes Königreich
      • Edinburgh, Vereinigtes Königreich, EH4 2XU
        • Western General Hospitals Nhs Trust
      • London, Vereinigtes Königreich, W12 OHS
        • Hammersmith Hospital
    • Hampshire
      • Southampton, Hampshire, Vereinigtes Königreich, SO16 6YD
        • Cancer Research UK Clinical Centre
    • Leicestershire
      • Leicester, Leicestershire, Vereinigtes Königreich, LE1 5WW
        • Department of Cancer Studies & Molecular Medicine

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 advanced (localized but surgically unresectable or metastatic) histologically/cytologically proven epithelial cancer of the exocrine pancreas
  • no prior therapy for metastatic disease

Exclusion Criteria:

  • patients with locally advanced disease who are candidates for radiation therapy.
  • uncontrolled brain metastases (a controlled brain metastasis must be previously treated, asymptomatic, and without growth for 4 months)

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: Gemcitabin
Arzneimittel: Gemcitabine
Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks
Arzneimittel: Gemcitabine
Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Experimental: Axitinib [AG-013736] plus gemcitabine
Arzneimittel: Gemcitabine
Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks
Arzneimittel: Gemcitabine
Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Arzneimittel: AG-013736
Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival (OS)
Zeitfenster: Baseline of Phase 2 to death or until at least 1 year after the randomization of the last participant
Time in days from randomization to date of death due to any cause. OS was calculated as the death date minus the date of randomization plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Baseline of Phase 2 to death or until at least 1 year after the randomization of the last participant

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)
Zeitfenster: Phase 1 baseline up to Week 4
Dose of axitinib (AG-013736) was confirmed if not more than 1 out of 6 participants experienced a DLT during first cycle. DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 anemia or non hematological toxicities for >= 7 days (except alopecia) or >= Gr 1 hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.
Phase 1 baseline up to Week 4
Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT)
Zeitfenster: Phase 1 Baseline up to Week 4
Dose of gemcitabine was confirmed if not more than 1 out of 6 participants experienced a DLT during first cycle. DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 anemia or non hematological toxicities for >= 7 days (except alopecia) or >= Gr 1 hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.
Phase 1 Baseline up to Week 4
Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)
Zeitfenster: 0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hours (hr) post-dose on Day 15 of Phase 1 Cycle 1
0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hours (hr) post-dose on Day 15 of Phase 1 Cycle 1
Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Axitinib (AG-013736)
Zeitfenster: 0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1
AUC (0-24) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 24 hours (0-24).
0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG-013736)
Zeitfenster: 0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1
Tmax was based on the actual time points when the samples were collected.
0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1
Plasma Decay Half-life (t1/2) of Axitinib (AG-013736)
Zeitfenster: 0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1
Maximum Observed Plasma Concentration (Cmax) of Gemcitabine
Zeitfenster: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Gemcitabine
Zeitfenster: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1
Plasma Decay Half-life (t1/2) of Gemcitabine
Zeitfenster: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1
Population Pharmacokinetics of Axitinib (AG-013736) in Phase 2
Zeitfenster: Phase 2 Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 80 weeks
Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Phase 2 Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 80 weeks
Percentage of Participants With Overall Response (OR)
Zeitfenster: Phase 2 baseline to disease progression or discontinuation from study, assessed every 8 weeks up to 80 weeks
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non-target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions.
Phase 2 baseline to disease progression or discontinuation from study, assessed every 8 weeks up to 80 weeks
Duration of Response (DR)
Zeitfenster: Phase 2 baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 80 weeks
Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Phase 2 baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 80 weeks
Progression-free Survival (PFS)
Zeitfenster: Phase 2 baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 80 weeks
Time in days from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of randomization plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Phase 2 baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 80 weeks
One Year Survival Probability
Zeitfenster: Phase 2 baseline to disease progression or death due to any cause or at least 1 year after the first dose for the last participant
One year survival probability was defined as the probability of survival at one year after the date of randomization based on the Kaplan Meier estimate.
Phase 2 baseline to disease progression or death due to any cause or at least 1 year after the first dose for the last participant
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score at Day 1 of Every Cycle and End of Study
Zeitfenster: Phase 2 baseline [Day (D)1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.
Phase 2 baseline [Day (D)1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).
Change From Baseline in 26-item Pancreatic Cancer-specific Quality of Life Questionnaire (QLQ-PAN26) Score at Day 1 of Every Cycle and End of Study
Zeitfenster: Phase 2 baseline [Day (D) 1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).
QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100. Higher scores on functioning scales=better functioning; higher scores on the symptom scales=more symptoms.
Phase 2 baseline [Day (D) 1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).

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.

Allgemeine Veröffentlichungen

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 (Tatsächlich)

5. Juli 2005

Primärer Abschluss (Tatsächlich)

14. März 2008

Studienabschluss (Tatsächlich)

14. März 2008

Studienanmeldedaten

Zuerst eingereicht

13. September 2005

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. September 2005

Zuerst gepostet (Schätzen)

22. September 2005

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. Mai 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. April 2019

Zuletzt verifiziert

1. April 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • A4061016
  • 2005-000053-30 (EudraCT-Nummer)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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