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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00471146
Registration number
NCT00471146
Ethics application status
Date submitted
7/05/2007
Date registered
9/05/2007
Date last updated
16/07/2012
Titles & IDs
Public title
Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.
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Scientific title
A Randomized, Double-Blind Phase 3 Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For The First-Line Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer.
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Secondary ID [1]
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A4061028
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Pancreatic Ductal
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Condition category
Condition code
Cancer
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Pancreatic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AG-013736
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Gemcitabine
Treatment: Drugs - placebo
Experimental: A -
Active comparator: B -
Treatment: Drugs: AG-013736
oral administration, starting dose 5 mg twice daily \[BID\] every day until unacceptable toxicity or tumor progression.
Treatment: Drugs: Gemcitabine
intravenous administration at 1,000 mg/m\^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.
Treatment: Drugs: Gemcitabine
intravenous administration at 1,000 mg/m\^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.
Treatment: Drugs: placebo
placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
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Timepoint [1]
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Baseline until death or at least 1 year after the randomization of last participant
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Secondary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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Time in weeks from randomization to the first documentation of objective tumor progression or death due to any cause. PFS was calculated as = (first event date minus randomization date plus 1) divided by 7. 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").
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Timepoint [1]
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Baseline until disease progression or at least 1 year after the randomization of last participant
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Secondary outcome [2]
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Percentage of Participants With Objective Response (OR)
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Assessment method [2]
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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 response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
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Timepoint [2]
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Baseline, every 8 weeks until tumor progression or death
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Secondary outcome [3]
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Duration of Response (DR)
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Assessment method [3]
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Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. 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) divided by 7.
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Timepoint [3]
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Baseline until death or at least 1 year after the randomization of last participant
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Secondary outcome [4]
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Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
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Assessment method [4]
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EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), 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.
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Timepoint [4]
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Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
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Secondary outcome [5]
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score
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Assessment method [5]
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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= greater degree of symptoms or treatment side effects and emotional issues.
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Timepoint [5]
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Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
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Secondary outcome [6]
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Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score
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Assessment method [6]
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BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference.
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Timepoint [6]
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Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
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Secondary outcome [7]
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Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile
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Assessment method [7]
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EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
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Timepoint [7]
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Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
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Secondary outcome [8]
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Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score
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Assessment method [8]
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EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
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Timepoint [8]
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Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
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Secondary outcome [9]
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Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)
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Assessment method [9]
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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.
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Timepoint [9]
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Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months
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Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection.
* Adequate renal, hepatic and bone marrow function.
* Performance status 0 or 1.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior treatment with any systemic chemotherapy for metastatic disease.
* Prior treatment with gemcitabine, AG-013736, or other vascular endothelial growth factor inhibitors.
* Current or recent bleeding, thromboembolic event and or use of a thrombolytic agent.
* Inability to take oral medication.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2010
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Sample size
Target
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Accrual to date
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Final
630
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Pfizer Investigational Site - St. Leonards
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Recruitment hospital [2]
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Pfizer Investigational Site - Wollongong
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Recruitment hospital [3]
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Pfizer Investigational Site - Clayton
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Recruitment hospital [4]
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Pfizer Investigational Site - East Bentleigh
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Recruitment postcode(s) [1]
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2065 - St. Leonards
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Recruitment postcode(s) [2]
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2500 - Wollongong
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3165 - East Bentleigh
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Recruitment outside Australia
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United States of America
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California
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Mississippi
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Missouri
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Nebraska
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Santa Fe
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Bruxelles
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Clichy cedex
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La Chaussee Saint Victor
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Marseille
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PARIS Cedex 13
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France
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Rouen
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St Herblain Cedex
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Dresden
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Essen
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Muenchen
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Oldenburg
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Ulm
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NT
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Szentes
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India
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Tamil Nadu
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Dublin 24
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Italy
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Padova
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Russian Federation
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Russian Federation
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Omsk
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Russian Federation
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Sochi
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Russian Federation
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Singapore
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Cape Town
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Observatory
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South Africa
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Parktown
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South Africa
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Port Elizabeth
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Pretoria
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Sandton
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Islas Baleares
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Toledo
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Country [107]
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Sweden
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State/province [107]
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Lund
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Country [108]
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Sweden
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State/province [108]
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Uppsala
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Country [109]
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Switzerland
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State/province [109]
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Winterthur
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Country [110]
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Taiwan
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State/province [110]
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Taoyuan County
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Country [111]
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0
Taiwan
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State/province [111]
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Taichung
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Country [112]
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0
Taiwan
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State/province [112]
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Taipei
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Country [113]
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United Kingdom
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State/province [113]
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Cardiff
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Country [114]
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United Kingdom
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State/province [114]
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Kent
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Country [115]
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United Kingdom
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State/province [115]
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Leicestershire
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Country [116]
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United Kingdom
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State/province [116]
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Manchester
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Country [117]
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United Kingdom
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State/province [117]
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Middlesex
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Country [118]
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United Kingdom
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State/province [118]
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Birmingham
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Country [119]
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United Kingdom
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State/province [119]
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Edinburgh
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Country [120]
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United Kingdom
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State/province [120]
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London
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Country [121]
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United Kingdom
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State/province [121]
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Southhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.
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Trial website
https://clinicaltrials.gov/study/NCT00471146
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Trial related presentations / publications
Kindler HL, Ioka T, Richel DJ, Bennouna J, Letourneau R, Okusaka T, Funakoshi A, Furuse J, Park YS, Ohkawa S, Springett GM, Wasan HS, Trask PC, Bycott P, Ricart AD, Kim S, Van Cutsem E. Axitinib plus gemcitabine versus placebo plus gemcitabine in patients with advanced pancreatic adenocarcinoma: a double-blind randomised phase 3 study. Lancet Oncol. 2011 Mar;12(3):256-62. doi: 10.1016/S1470-2045(11)70004-3.
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00471146
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