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

2019年4月22日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

111

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：ゲムシタビン
薬：Gemcitabine
Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks
薬：Gemcitabine
Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
実験的：Axitinib [AG-013736] plus gemcitabine
薬：Gemcitabine
Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks
薬：Gemcitabine
Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
薬：AG-013736
Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Overall Survival (OS)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Pfizer

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2005年7月5日

一次修了 (実際)

2008年3月14日

研究の完了 (実際)

2008年3月14日

試験登録日

最初に提出

2005年9月13日

QC基準を満たした最初の提出物

2005年9月13日

最初の投稿 (見積もり)

2005年9月22日

学習記録の更新

投稿された最後の更新 (実際)

2019年5月14日

QC基準を満たした最後の更新が送信されました

2019年4月22日

最終確認日

2019年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

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

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

膵臓の新生物の臨床試験

  • Washington University School of Medicine
    University of Oklahoma Medical Center; Northwestern University Chicago Illinois; Saint Luke's...
    完了
    WON の放射線予測因子
    Walled Off Pancreatic Necrosis (WON)
    アメリカ

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