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

maanantai 22. huhtikuuta 2019 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

111

Vaihe

  • Vaihe 2

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Belgia
      • Gent, Belgia, 9000
        • Universitair Ziekenhuis Gent/Dienst Gastroenterologie
  • Espanja
      • Barcelona, Espanja, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Espanja, 08035
        • Hospital Universitario Vall d´Hebron
      • Sevilla, Espanja, 41013
        • Hospital Universitario Virgen del Rocío
  • 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
  • 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
  • Ranska
      • Marseille, Ranska, 13005
        • Hôpital La Timone
      • Paris Cedex 13, Ranska, 75651
        • Hôpital de la Pitié Salpêtrière
      • Toulouse, Ranska, 31052
        • Institut Claudius Regaud
    • Saint Herblain Cedex
      • Saint-Herblain, Saint Herblain Cedex, Ranska, 44805
        • Service Oncologie Medicale
  • Saksa
      • Berlin, Saksa, 13353
        • Medizinische Klinik mit Schwerpunkt Haematologie und Onkologie, Charité-Universitaetsmedizin Berlin
  • Yhdistynyt kuningaskunta
      • Edinburgh, Yhdistynyt kuningaskunta, EH4 2XU
        • Western General Hospitals Nhs Trust
      • London, Yhdistynyt kuningaskunta, W12 OHS
        • Hammersmith Hospital
    • Hampshire
      • Southampton, Hampshire, Yhdistynyt kuningaskunta, SO16 6YD
        • Cancer Research UK Clinical Centre
    • Leicestershire
      • Leicester, Leicestershire, Yhdistynyt kuningaskunta, LE1 5WW
        • Department of Cancer Studies & Molecular Medicine
  • Yhdysvallat
    • California
      • Antioch, California, Yhdysvallat, 94509
        • East Bay Medical Oncology/Hematology Medical Associates Inc.
      • Berkeley, California, Yhdysvallat, 94704
        • Alta Bates Comprehensive Cancer Center
      • Concord, California, Yhdysvallat, 94520
        • Bay Area Cancer Research Group
      • Concord, California, Yhdysvallat, 94520
        • East Bay Medical Oncology/Hematology Medical Associates, Inc.
    • Connecticut
      • Stamford, Connecticut, Yhdysvallat, 06902-3628
        • Hematology Oncology, P.C.
    • Florida
      • Miami, Florida, Yhdysvallat, 33136
        • University of Miami Hospital & Clinics
      • Miami, Florida, Yhdysvallat, 33136
        • Jackson Memorial Hospital & Clinics
      • Tampa, Florida, Yhdysvallat, 33612-9497
        • H Lee Moffitt Cancer Center & Research Institute
    • Maine
      • Biddeford, Maine, Yhdysvallat, 04005
        • Maine Center for Cancer Medicine and Blood Disorders
      • Brunswick, Maine, Yhdysvallat, 04011
        • Maine Center for Cancer Medicine and Blood Disorders
      • Scarborough, Maine, Yhdysvallat, 04074
        • Maine Center for Cancer Medicine and Blood Disorders
    • Missouri
      • Saint Louis, Missouri, Yhdysvallat, 63141
        • Arch Medical Services, Inc. d/b/a The Center for Cancer Care and Research
      • Washington, Missouri, Yhdysvallat, 63090
        • Arch Medical Services, Inc. d/b/a The Center for Cancer Care and Research
    • Nebraska
      • Lincoln, Nebraska, Yhdysvallat, 68510
        • Southeast Nebraska Cancer Center, Southeast Nebraska Hematology and Oncology Consultants, P.C.
    • North Carolina
      • Winston-Salem, North Carolina, Yhdysvallat, 27103
        • Piedmont Hematology Oncology Association
      • Winston-Salem, North Carolina, Yhdysvallat, 27292
        • Piedmont Hematology Oncology Associates
    • Wisconsin
      • Madison, Wisconsin, Yhdysvallat, 53792
        • University of Wisconsin Hospital and Clinics

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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)

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Active Comparator: Gemsitabiini
Lääke: Gemcitabine
Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks
Lääke: Gemcitabine
Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Kokeellinen: Axitinib [AG-013736] plus gemcitabine
Lääke: Gemcitabine
Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks
Lääke: Gemcitabine
Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Lääke: AG-013736
Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Overall Survival (OS)
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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).

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Pfizer

Julkaisuja ja hyödyllisiä linkkejä

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Yleiset julkaisut

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Tiistai 5. heinäkuuta 2005

Ensisijainen valmistuminen (Todellinen)

Perjantai 14. maaliskuuta 2008

Opintojen valmistuminen (Todellinen)

Perjantai 14. maaliskuuta 2008

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 13. syyskuuta 2005

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 13. syyskuuta 2005

Ensimmäinen Lähetetty (Arvio)

Torstai 22. syyskuuta 2005

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Tiistai 14. toukokuuta 2019

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 22. huhtikuuta 2019

Viimeksi vahvistettu

Maanantai 1. huhtikuuta 2019

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

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

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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.

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