Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.

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.

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Pancreatic Ductal
• Intervention / Treatment: Drug: placebo; Drug: AG-013736; Drug: Gemcitabine

Detailed Description

This study was prematurely discontinued for futility on 23 January 2009, based on a planned interim analysis by an independent Data Safety Monitoring Board (DSMB) that found no evidence of improvement in the primary endpoint (survival) in patients treated with axitinib and gemcitabine compared to gemcitabine alone. Enrollment on this study has been discontinued.

• Study Type: Interventional
• Enrollment (Actual): 630
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma de Buenos Aires, Argentina, C1426ANZ
    • Pfizer Investigational Site
  • Santa Fe, Argentina, 3000
    • Pfizer Investigational Site
  • Buenos Aires
    • Bahia Blanca, Buenos Aires, Argentina, B8000FJI
      • Pfizer Investigational Site
    • La Plata, Buenos Aires, Argentina, B1900AVG
      • Pfizer Investigational Site
• Australia
  • New South Wales
    • St. Leonards, New South Wales, Australia, 2065
      • Pfizer Investigational Site
    • Wollongong, New South Wales, Australia, 2500
      • Pfizer Investigational Site
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Pfizer Investigational Site
    • East Bentleigh, Victoria, Australia, 3165
      • Pfizer Investigational Site
• Austria
  • Salzburg, Austria, A-5020
    • Pfizer Investigational Site
  • Wels, Austria, A-4600
    • Pfizer Investigational Site
  • Wien, Austria, A-1090
    • Pfizer Investigational Site
  • Wien, Austria, 1090
    • Pfizer Investigational Site
  • Wien, Austria, 1030
    • Pfizer Investigational Site
• Belgium
  • Brussel, Belgium, 1090
    • Pfizer Investigational Site
  • Bruxelles, Belgium, 1000
    • Pfizer Investigational Site
  • Bruxelles, Belgium, 1200
    • Pfizer Investigational Site
  • Gent, Belgium, 9000
    • Pfizer Investigational Site
  • Leuven, Belgium, 3000
    • Pfizer Investigational Site
  • Wilrijk, Belgium, 2610
    • Pfizer Investigational Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Pfizer Investigational Site
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 5L3
      • Pfizer Investigational Site
    • Victoria, British Columbia, Canada, V8R 6V5
      • Pfizer Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Pfizer Investigational Site
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • Pfizer Investigational Site
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • Pfizer Investigational Site
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Pfizer Investigational Site
    • Kingston, Ontario, Canada, K7L 5P9
      • Pfizer Investigational Site
    • Oshawa, Ontario, Canada, L1G 2B9
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M4N 3M5
      • Pfizer Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H2X 3J4
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H4J 1C5
      • Pfizer Investigational Site
• France
  • Clichy cedex, France, 92118
    • Pfizer Investigational Site
  • La Chaussee Saint Victor, France, 41260
    • Pfizer Investigational Site
  • Marseille, France, 13385 CEDEX 5
    • Pfizer Investigational Site
  • Montpellier Cedex 02, France, 34298
    • Pfizer Investigational Site
  • PARIS Cedex 13, France, 75651
    • Pfizer Investigational Site
  • Paris, France, 75015
    • Pfizer Investigational Site
  • Pessac Cedex, France, 33600
    • Pfizer Investigational Site
  • Rouen, France, 76041
    • Pfizer Investigational Site
  • St Herblain Cedex, France, 44805
    • Pfizer Investigational Site
• Germany
  • Berlin, Germany, 13353
    • Pfizer Investigational Site
  • Dresden, Germany, 01307
    • Pfizer Investigational Site
  • Essen, Germany, 45136
    • Pfizer Investigational Site
  • Greifswald, Germany, 17475
    • Pfizer Investigational Site
  • Magdeburg, Germany, 39130
    • Pfizer Investigational Site
  • Mannheim, Germany, 68167
    • Pfizer Investigational Site
  • Muenchen, Germany, 81377
    • Pfizer Investigational Site
  • Oldenburg, Germany, 26133
    • Pfizer Investigational Site
  • Ulm, Germany, 89081
    • Pfizer Investigational Site
• Hong Kong
  • NT
    • Shatin, NT, Hong Kong
      • Pfizer Investigational Site
• Hungary
  • Budapest, Hungary, 1122
    • Pfizer Investigational Site
  • Budapest, Hungary, 1106
    • Pfizer Investigational Site
  • Budapest, Hungary, 1097
    • Pfizer Investigational Site
  • Kaposvar, Hungary, 7400
    • Pfizer Investigational Site
  • Szentes, Hungary, 6600
    • Pfizer Investigational Site
  • Zalaegerszeg, Hungary, 8900
    • Pfizer Investigational Site
• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380 009
      • Pfizer Investigational Site
  • Karnataka
    • Bangalore, Karnataka, India, 560 078
      • Pfizer Investigational Site
  • Kerala
    • Cochin, Kerala, India, 682 304
      • Pfizer Investigational Site
  • Pradesh
    • Andhra, Pradesh, India, 500 034
      • Pfizer Investigational Site
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600035
      • Pfizer Investigational Site
• Ireland
  • Dublin, Ireland, 4
    • Pfizer Investigational Site
  • Dublin 24, Ireland
    • Pfizer Investigational Site
• Italy
  • Bologna, Italy, 40138
    • Pfizer Investigational Site
  • Catania, Italy, 95122
    • Pfizer Investigational Site
  • Milano, Italy, 20132
    • Pfizer Investigational Site
  • Milano, Italy, 20133
    • Pfizer Investigational Site
  • Padova, Italy, 35128
    • Pfizer Investigational Site
  • Verona, Italy, 37134
    • Pfizer Investigational Site
• Japan
  • Aichi
    • Nagoya, Aichi, Japan
      • Pfizer Investigational Site
  • Chiba
    • Chiba city, Chiba, Japan
      • Pfizer Investigational Site
    • Kashiwa-shi, Chiba, Japan
      • Pfizer Investigational Site
  • Chiba-ken
    • Chiba-shi, Chiba-ken, Japan
      • Pfizer Investigational Site
  • Fukuoka-ken
    • Fukuoka-shi, Fukuoka-ken, Japan
      • Pfizer Investigational Site
  • Kanagawa
    • Yokohama-shi, Kanagawa, Japan
      • Pfizer Investigational Site
  • Osaka-fu
    • Osaka-shi, Osaka-fu, Japan
      • Pfizer Investigational Site
  • Shizuoka
    • Suntougun, Shizuoka, Japan
      • Pfizer Investigational Site
  • Tokyo
    • Chuo-ku, Tokyo, Japan
      • Pfizer Investigational Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 110-744
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 135-710
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 136-705
    • Pfizer Investigational Site
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Pfizer Investigational Site
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1105 AZ
      • Pfizer Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 115478
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 129128
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 125376
    • Pfizer Investigational Site
  • Omsk, Russian Federation, 644013
    • Pfizer Investigational Site
  • Sochi, Russian Federation, 354057
    • Pfizer Investigational Site
  • St. Petersburg, Russian Federation, 191104
    • Pfizer Investigational Site
  • St. Petersburg, Russian Federation, 198255
    • Pfizer Investigational Site
• Singapore
  • Singapore, Singapore, 119074
    • Pfizer Investigational Site
  • Singapore, Singapore, 16910
    • Pfizer Investigational Site
• South Africa
  • Cape Town, South Africa, 7500
    • Pfizer Investigational Site
  • Observatory, South Africa, 7925
    • Pfizer Investigational Site
  • Parktown, South Africa, 2193
    • Pfizer Investigational Site
  • Port Elizabeth, South Africa, 6001
    • Pfizer Investigational Site
  • Pretoria, South Africa, 0181
    • Pfizer Investigational Site
  • Sandton, South Africa, 2199
    • Pfizer Investigational Site
• Spain
  • Barcelona, Spain, 08035
    • Pfizer Investigational Site
  • Barcelona, Spain, 08036
    • Pfizer Investigational Site
  • Las Palmas de Gran Canaria, Spain, 35020
    • Pfizer Investigational Site
  • Madrid, Spain, 28046
    • Pfizer Investigational Site
  • Malaga, Spain, 29010
    • Pfizer Investigational Site
  • Santa Cruz de Tenerife, Spain, 38320
    • Pfizer Investigational Site
  • Toledo, Spain, 45004
    • Pfizer Investigational Site
  • Islas Baleares
    • Palma de Mallorca, Islas Baleares, Spain, 07198
      • Pfizer Investigational Site
  • Madrid
    • Mostoles, Madrid, Spain, 28935
      • Pfizer Investigational Site
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Pfizer Investigational Site
• Sweden
  • Lund, Sweden, 221 85
    • Pfizer Investigational Site
  • Uppsala, Sweden, 751 85
    • Pfizer Investigational Site
• Switzerland
  • Winterthur, Switzerland, 8401
    • Pfizer Investigational Site
• Taiwan
  • Taichung, Taiwan, 404
    • Pfizer Investigational Site
  • Taipei, Taiwan, 112
    • Pfizer Investigational Site
  • Taoyuan County
    • Kuei-Shan Jsoamg, Taoyuan County, Taiwan, 333
      • Pfizer Investigational Site
• United Kingdom
  • Birmingham, United Kingdom, B15 2TT
    • Pfizer Investigational Site
  • Birmingham, United Kingdom, B15 2TA
    • Pfizer Investigational Site
  • Edinburgh, United Kingdom, EH4 2XU
    • Pfizer Investigational Site
  • London, United Kingdom, EC1A 7BE
    • Pfizer Investigational Site
  • London, United Kingdom, W12 OHS
    • Pfizer Investigational Site
  • Manchester, United Kingdom, M20 4BX
    • Pfizer Investigational Site
  • Southhampton, United Kingdom, S016 6YD
    • Pfizer Investigational Site
  • Cardiff
    • Whitchurch, Cardiff, United Kingdom, CF14 2TL
      • Pfizer Investigational Site
  • Kent
    • Maidstone, Kent, United Kingdom, ME16 9QQ
      • Pfizer Investigational Site
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE1 5WW
      • Pfizer Investigational Site
  • Manchester
    • Withington, Manchester, United Kingdom, M20 4BX
      • Pfizer Investigational Site
  • Middlesex
    • Northwood, Middlesex, United Kingdom, HA6 2RN
      • Pfizer Investigational Site
• United States
  • California
    • Antioch, California, United States, 94531
      • Pfizer Investigational Site
    • Corona, California, United States, 92878
      • Pfizer Investigational Site
    • Glendora, California, United States, 91741
      • Pfizer Investigational Site
    • La Jolla, California, United States, 92037
      • Pfizer Investigational Site
    • La Jolla, California, United States, 92093
      • Pfizer Investigational Site
    • LaVerne, California, United States, 91750
      • Pfizer Investigational Site
    • Pamona, California, United States, 91105
      • Pfizer Investigational Site
    • Pasadena, California, United States, 91105
      • Pfizer Investigational Site
    • Pleasent Hill, California, United States, 94523
      • Pfizer Investigational Site
    • Pomona, California, United States, 91767
      • Pfizer Investigational Site
    • Rancho Cucamonga, California, United States, 91730
      • Pfizer Investigational Site
    • Rancho Mirage, California, United States, 92270
      • Pfizer Investigational Site
    • Redlands, California, United States, 92374
      • Pfizer Investigational Site
    • San Diego, California, United States, 92103
      • Pfizer Investigational Site
    • San Diego, California, United States, 92161
      • Pfizer Investigational Site
    • San Leandro, California, United States, 94578
      • Pfizer Investigational Site
    • West Covina, California, United States, 91790
      • Pfizer Investigational Site
  • Florida
    • Hollywood, Florida, United States, 33021
      • Pfizer Investigational Site
    • Pembroke Pines, Florida, United States, 33028
      • Pfizer Investigational Site
    • Stuart, Florida, United States, 34994
      • Pfizer Investigational Site
    • Tampa, Florida, United States, 33612
      • Pfizer Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Pfizer Investigational Site
    • Augusta, Georgia, United States, 30909
      • Pfizer Investigational Site
    • Augusta, Georgia, United States, 30901
      • Pfizer Investigational Site
  • Idaho
    • Coeur D'Alene, Idaho, United States, 83814
      • Pfizer Investigational Site
  • Illinois
    • Alton, Illinois, United States, 62002
      • Pfizer Investigational Site
    • Chicago, Illinois, United States, 60637
      • Pfizer Investigational Site
  • Indiana
    • Beech Grove, Indiana, United States, 46107
      • Pfizer Investigational Site
    • Indianapolis, Indiana, United States, 46260
      • Pfizer Investigational Site
    • Indianapolis, Indiana, United States, 46237
      • Pfizer Investigational Site
    • Jeffersonville, Indiana, United States, 47130
      • Pfizer Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Pfizer Investigational Site
    • Louisville, Kentucky, United States, 40217
      • Pfizer Investigational Site
    • Louisville, Kentucky, United States, 40241
      • Pfizer Investigational Site
    • Louisville, Kentucky, United States, 40207
      • Pfizer Investigational Site
    • Shelbyville, Kentucky, United States, 40065
      • Pfizer Investigational Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Pfizer Investigational Site
    • Baton Rouge, Louisiana, United States, 70806
      • Pfizer Investigational Site
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Pfizer Investigational Site
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Pfizer Investigational Site
    • Peabody, Massachusetts, United States, 01960
      • Pfizer Investigational Site
  • Michigan
    • Kalamazoo, Michigan, United States, 49007
      • Pfizer Investigational Site
  • Mississippi
    • Columbus, Mississippi, United States, 39705
      • Pfizer Investigational Site
    • Corinth, Mississippi, United States, 38834
      • Pfizer Investigational Site
    • Southaven, Mississippi, United States, 38671
      • Pfizer Investigational Site
    • Tupelo, Mississippi, United States, 38801
      • Pfizer Investigational Site
  • Missouri
    • St. Louis, Missouri, United States, 63136
      • Pfizer Investigational Site
  • Montana
    • Billings, Montana, United States, 59101
      • Pfizer Investigational Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Pfizer Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89135
      • Pfizer Investigational Site
  • New York
    • Mineola, New York, United States, 11501
      • Pfizer Investigational Site
    • Syracuse, New York, United States, 13210
      • Pfizer Investigational Site
  • Ohio
    • Canton, Ohio, United States, 44718
      • Pfizer Investigational Site
    • Columbus, Ohio, United States, 43214
      • Pfizer Investigational Site
    • Sylvania, Ohio, United States, 43560
      • Pfizer Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97227-1191
      • Pfizer Investigational Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Pfizer Investigational Site
    • Knoxville, Tennessee, United States, 37916
      • Pfizer Investigational Site
    • Knoxville, Tennessee, United States, 37934
      • Pfizer Investigational Site
    • Memphis, Tennessee, United States, 38104
      • Pfizer Investigational Site
    • Memphis, Tennessee, United States, 38120
      • Pfizer Investigational Site
  • Texas
    • Austin, Texas, United States, 78705
      • Pfizer Investigational Site
    • Austin, Texas, United States, 78745
      • Pfizer Investigational Site
    • Austin, Texas, United States, 78759
      • Pfizer Investigational Site
    • Austin, Texas, United States, 78758
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75390
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75325-7786
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75325
      • Pfizer Investigational Site
    • Round Rock, Texas, United States, 78664
      • Pfizer Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Pfizer Investigational Site
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Pfizer Investigational Site
  • Washington
    • Everett, Washington, United States, 98201
      • Pfizer Investigational Site
    • Federal Way, Washington, United States, 98003
      • Pfizer Investigational Site
    • Kennewick, Washington, United States, 99336
      • Pfizer Investigational Site
    • Lakewood, Washington, United States, 98499
      • Pfizer Investigational Site
    • Puyallup, Washington, United States, 98372
      • Pfizer Investigational Site
    • Tacoma, Washington, United States, 98405
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: B	Drug: placebo; placebo; Drug: 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.
Experimental: A	Drug: AG-013736; oral administration, starting dose 5 mg twice daily [BID] every day until unacceptable toxicity or tumor progression.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	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).	Baseline until death or at least 1 year after the randomization of last participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	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").	Baseline until disease progression or at least 1 year after the randomization of last participant
Percentage of Participants With Objective Response (OR)	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.	Baseline, every 8 weeks until tumor progression or death
Duration of Response (DR)	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.	Baseline until death or at least 1 year after the randomization of last participant
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score	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.	Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score	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.	Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score	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.	Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile	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.	Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score	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.	Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)	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.	Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: May 7, 2007
• First Submitted That Met QC Criteria: May 7, 2007
• First Posted (Estimate): May 9, 2007

Study Record Updates

• Last Update Posted (Estimate): July 16, 2012
• Last Update Submitted That Met QC Criteria: June 14, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Randomized Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For Advanced Pancreatic Cancer.
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma, Ductal; Pancreatic Neoplasms; Carcinoma, Pancreatic Ductal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protein Kinase Inhibitors; Gemcitabine; Axitinib
• Other Study ID Numbers: A4061028