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

22 aprile 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

111

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Gemcitabina
Droga: Gemcitabine
Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks
Droga: Gemcitabine
Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Sperimentale: Axitinib [AG-013736] plus gemcitabine
Droga: Gemcitabine
Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks
Droga: Gemcitabine
Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Droga: AG-013736
Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 luglio 2005

Completamento primario (Effettivo)

14 marzo 2008

Completamento dello studio (Effettivo)

14 marzo 2008

Date di iscrizione allo studio

Primo inviato

13 settembre 2005

Primo inviato che soddisfa i criteri di controllo qualità

13 settembre 2005

Primo Inserito (Stima)

22 settembre 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 maggio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 aprile 2019

Ultimo verificato

1 aprile 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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