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Carcinoma, Pancreatic DuctalPhase 3NCT00471146

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

A Phase 3 study testing AG-013736 and Gemcitabine in people with Carcinoma, Pancreatic Ductal, run by Pfizer at 204 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Pancreatic Ductal
What is being tested?
AG-013736 and Gemcitabine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
630 participants
Where
204 sitesin 24 countries
Study dates
Jul 2007to Nov 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

204 sites in 24 countries.

204 sites in 24 countries

United States77 sites

  • Pfizer Investigational Site

    Alton, Illinois, 62002

  • Pfizer Investigational Site

    Annapolis, Maryland, 21401

  • Pfizer Investigational Site

    Antioch, California, 94531

  • Pfizer Investigational Site

    Atlanta, Georgia, 30309

  • Pfizer Investigational Site

    Augusta, Georgia, 30901

  • Pfizer Investigational Site

    Augusta, Georgia, 30909

  • Pfizer Investigational Site

    Austin, Texas, 78705

  • Pfizer Investigational Site

    Austin, Texas, 78745

  • Pfizer Investigational Site

    Austin, Texas, 78758

  • Pfizer Investigational Site

    Austin, Texas, 78759

  • Pfizer Investigational Site

    Baton Rouge, Louisiana, 70806

  • Pfizer Investigational Site

    Baton Rouge, Louisiana, 70809

  • Pfizer Investigational Site

    Beech Grove, Indiana, 46107

  • Pfizer Investigational Site

    Billings, Montana, 59101

  • Pfizer Investigational Site

    Burlington, Massachusetts, 01805

  • Pfizer Investigational Site

    Canton, Ohio, 44718

  • Pfizer Investigational Site

    Chicago, Illinois, 60637

  • Pfizer Investigational Site

    Coeur d'Alene, Idaho, 83814

  • Pfizer Investigational Site

    Columbus, Mississippi, 39705

  • Pfizer Investigational Site

    Columbus, Ohio, 43214

  • Pfizer Investigational Site

    Corinth, Mississippi, 38834

  • Pfizer Investigational Site

    Corona, California, 92878

  • Pfizer Investigational Site

    Dallas, Texas, 75325-7786

  • Pfizer Investigational Site

    Dallas, Texas, 75325

  • Pfizer Investigational Site

    Dallas, Texas, 75390

  • Pfizer Investigational Site

    Everett, Washington, 98201

  • Pfizer Investigational Site

    Federal Way, Washington, 98003

  • Pfizer Investigational Site

    Glendora, California, 91741

  • Pfizer Investigational Site

    Hollywood, Florida, 33021

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46237

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46260

  • Pfizer Investigational Site

    Jeffersonville, Indiana, 47130

  • Pfizer Investigational Site

    Kalamazoo, Michigan, 49007

  • Pfizer Investigational Site

    Kennewick, Washington, 99336

  • Pfizer Investigational Site

    Knoxville, Tennessee, 37916

  • Pfizer Investigational Site

    Knoxville, Tennessee, 37920

  • Pfizer Investigational Site

    Knoxville, Tennessee, 37934

  • Pfizer Investigational Site

    La Jolla, California, 92037

  • Pfizer Investigational Site

    La Jolla, California, 92093

  • Pfizer Investigational Site

    Lakewood, Washington, 98499

  • Pfizer Investigational Site

    Las Vegas, Nevada, 89135

  • Pfizer Investigational Site

    LaVerne, California, 91750

  • Pfizer Investigational Site

    Lincoln, Nebraska, 68510

  • Pfizer Investigational Site

    Louisville, Kentucky, 40202

  • Pfizer Investigational Site

    Louisville, Kentucky, 40207

  • Pfizer Investigational Site

    Louisville, Kentucky, 40217

  • Pfizer Investigational Site

    Louisville, Kentucky, 40241

  • Pfizer Investigational Site

    Lynchburg, Virginia, 24501

  • Pfizer Investigational Site

    Memphis, Tennessee, 38104

  • Pfizer Investigational Site

    Memphis, Tennessee, 38120

  • Pfizer Investigational Site

    Mineola, New York, 11501

  • Pfizer Investigational Site

    Pasadena, California, 91105

  • Pfizer Investigational Site

    Peabody, Massachusetts, 01960

  • Pfizer Investigational Site

    Pembroke Pines, Florida, 33028

  • Pfizer Investigational Site

    Pleasent Hill, California, 94523

  • Pfizer Investigational Site

    Pomona, California, 91105

  • Pfizer Investigational Site

    Pomona, California, 91767

  • Pfizer Investigational Site

    Portland, Oregon, 97227-1191

  • Pfizer Investigational Site

    Puyallup, Washington, 98372

  • Pfizer Investigational Site

    Rancho Cucamonga, California, 91730

  • Pfizer Investigational Site

    Rancho Mirage, California, 92270

  • Pfizer Investigational Site

    Redlands, California, 92374

  • Pfizer Investigational Site

    Round Rock, Texas, 78664

  • Pfizer Investigational Site

    Salt Lake City, Utah, 84112

  • Pfizer Investigational Site

    San Diego, California, 92103

  • Pfizer Investigational Site

    San Diego, California, 92161

  • Pfizer Investigational Site

    San Leandro, California, 94578

  • Pfizer Investigational Site

    Shelbyville, Kentucky, 40065

  • Pfizer Investigational Site

    Southaven, Mississippi, 38671

  • Pfizer Investigational Site

    St Louis, Missouri, 63136

  • Pfizer Investigational Site

    Stuart, Florida, 34994

  • Pfizer Investigational Site

    Sylvania, Ohio, 43560

  • Pfizer Investigational Site

    Syracuse, New York, 13210

  • Pfizer Investigational Site

    Tacoma, Washington, 98405

  • Pfizer Investigational Site

    Tampa, Florida, 33612

  • Pfizer Investigational Site

    Tupelo, Mississippi, 38801

  • Pfizer Investigational Site

    West Covina, California, 91790

Other trials in United States

Canada13 sites

  • Pfizer Investigational Site

    Edmonton, Alberta, T6G 1Z2

  • Pfizer Investigational Site

    Kelowna, British Columbia, V1Y 5L3

  • Pfizer Investigational Site

    Kingston, Ontario, K7L 2V7

  • Pfizer Investigational Site

    Kingston, Ontario, K7L 5P9

  • Pfizer Investigational Site

    Moncton, New Brunswick, E1C 6Z8

  • Pfizer Investigational Site

    Montreal, Quebec, H1T 2M4

  • Pfizer Investigational Site

    Montreal, Quebec, H2X 3J4

  • Pfizer Investigational Site

    Montreal, Quebec, H4J 1C5

  • Pfizer Investigational Site

    Oshawa, Ontario, L1G 2B9

  • Pfizer Investigational Site

    Toronto, Ontario, M4N 3M5

  • Pfizer Investigational Site

    Victoria, British Columbia, V8R 6V5

  • Pfizer Investigational Site

    Winnipeg, Manitoba, R2H 2A6

  • Pfizer Investigational Site

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

United Kingdom12 sites

  • Pfizer Investigational Site

    Birmingham, B15 2TA

  • Pfizer Investigational Site

    Birmingham, B15 2TT

  • Pfizer Investigational Site

    Edinburgh, EH4 2XU

  • Pfizer Investigational Site

    Leicester, Leicestershire, LE1 5WW

  • Pfizer Investigational Site

    London, EC1A 7BE

  • Pfizer Investigational Site

    London, W12 OHS

  • Pfizer Investigational Site

    Maidstone, Kent, ME16 9QQ

  • Pfizer Investigational Site

    Manchester, M20 4BX

  • Pfizer Investigational Site

    Northwood, Middlesex, HA6 2RN

  • Pfizer Investigational Site

    Southhampton, S016 6YD

  • Pfizer Investigational Site

    Whitchurch, Cardiff, CF14 2TL

  • Pfizer Investigational Site

    Withington, Manchester, M20 4BX

Other trials in United Kingdom

Spain10 sites

  • Pfizer Investigational Site

    Barcelona, Barcelona, 08035

  • Pfizer Investigational Site

    Barcelona, Barcelona, 08036

  • Pfizer Investigational Site

    Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35020

  • Pfizer Investigational Site

    Madrid, Madrid, 28046

  • Pfizer Investigational Site

    Málaga, Malaga, 29010

  • Pfizer Investigational Site

    Móstoles, Madrid, 28935

  • Pfizer Investigational Site

    Palma de Mallorca, Balearic Islands, 07198

  • Pfizer Investigational Site

    Pamplona, Navarre, 31008

  • Pfizer Investigational Site

    Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38320

  • Pfizer Investigational Site

    Toledo, Toledo, 45004

Other trials in Spain

France9 sites

  • Pfizer Investigational Site

    Clichy, 92118

  • Pfizer Investigational Site

    La Chaussée-Saint-Victor, 41260

  • Pfizer Investigational Site

    Marseille, 13385 CEDEX 5

  • Pfizer Investigational Site

    Montpellier, 34298

  • Pfizer Investigational Site

    Paris, 75015

  • Pfizer Investigational Site

    Paris, 75651

  • Pfizer Investigational Site

    Pessac, 33600

  • Pfizer Investigational Site

    Rouen, 76041

  • Pfizer Investigational Site

    Saint-Herblain, 44805

Other trials in France

Germany9 sites

  • Pfizer Investigational Site

    Berlin, 13353

  • Pfizer Investigational Site

    Dresden, 01307

  • Pfizer Investigational Site

    Essen, 45136

  • Pfizer Investigational Site

    Greifswald, 17475

  • Pfizer Investigational Site

    Magdeburg, 39130

  • Pfizer Investigational Site

    Mannheim, 68167

  • Pfizer Investigational Site

    München, 81377

  • Pfizer Investigational Site

    Oldenburg, 26133

  • Pfizer Investigational Site

    Ulm, 89081

Other trials in Germany

Japan8 sites

  • Pfizer Investigational Site

    Chiba, Chiba

  • Pfizer Investigational Site

    Chuo-ku, Tokyo

  • Pfizer Investigational Site

    Fukuoka, Fukuoka

  • Pfizer Investigational Site

    Kashiwa-shi, Chiba

  • Pfizer Investigational Site

    Nagoya, Aichi-ken

  • Pfizer Investigational Site

    Osaka, Osaka

  • Pfizer Investigational Site

    Suntougun, Shizuoka

  • Pfizer Investigational Site

    Yokohama, Kanagawa

Other trials in Japan

Russia7 sites

  • Pfizer Investigational Site

    Moscow, Moscow, 129128

  • Pfizer Investigational Site

    Moscow, 115478

  • Pfizer Investigational Site

    Moscow, 125376

  • Pfizer Investigational Site

    Omsk, 644013

  • Pfizer Investigational Site

    Saint Petersburg, 191104

  • Pfizer Investigational Site

    Saint Petersburg, 198255

  • Pfizer Investigational Site

    Sochi, 354057

Other trials in Russia

Belgium6 sites

  • Pfizer Investigational Site

    Brussels, 1000

  • Pfizer Investigational Site

    Brussels, 1090

  • Pfizer Investigational Site

    Brussels, 1200

  • Pfizer Investigational Site

    Ghent, 9000

  • Pfizer Investigational Site

    Leuven, 3000

  • Pfizer Investigational Site

    Wilrijk, 2610

Other trials in Belgium

Hungary6 sites

  • Pfizer Investigational Site

    Budapest, 1097

  • Pfizer Investigational Site

    Budapest, 1106

  • Pfizer Investigational Site

    Budapest, 1122

  • Pfizer Investigational Site

    Kaposvár, 7400

  • Pfizer Investigational Site

    Szentes, 6600

  • Pfizer Investigational Site

    Zalaegerszeg, 8900

Other trials in Hungary

Italy6 sites

  • Pfizer Investigational Site

    Bologna, 40138

  • Pfizer Investigational Site

    Catania, 95122

  • Pfizer Investigational Site

    Milan, 20132

  • Pfizer Investigational Site

    Milan, 20133

  • Pfizer Investigational Site

    Padova, 35128

  • Pfizer Investigational Site

    Verona, 37134

Other trials in Italy

South Africa6 sites

  • Pfizer Investigational Site

    Cape Town, 7500

  • Pfizer Investigational Site

    Observatory, 7925

  • Pfizer Investigational Site

    Parktown, 2193

  • Pfizer Investigational Site

    Port Elizabeth, 6001

  • Pfizer Investigational Site

    Pretoria, 0181

  • Pfizer Investigational Site

    Sandton, 2199

Other trials in South Africa

Austria5 sites

  • Pfizer Investigational Site

    Salzburg, A-5020

  • Pfizer Investigational Site

    Vienna, 1030

  • Pfizer Investigational Site

    Vienna, 1090

  • Pfizer Investigational Site

    Vienna, A-1090

  • Pfizer Investigational Site

    Wels, A-4600

Other trials in Austria

India5 sites

  • Pfizer Investigational Site

    Ahmedabad, Gujarat, 380 009

  • Pfizer Investigational Site

    Andhra, Pradesh, 500 034

  • Pfizer Investigational Site

    Bangalore, Karnataka, 560 078

  • Pfizer Investigational Site

    Chennai, Tamil Nadu, 600035

  • Pfizer Investigational Site

    Kochi, Kerala, 682 304

Other trials in India

Argentina4 sites

  • Pfizer Investigational Site

    Bahía Blanca, Buenos Aires, B8000FJI

  • Pfizer Investigational Site

    Buenos Aires, C1426ANZ

  • Pfizer Investigational Site

    La Plata, Buenos Aires, B1900AVG

  • Pfizer Investigational Site

    Santa Fe, Santa Fe Province, 3000

Other trials in Argentina

Australia4 sites

  • Pfizer Investigational Site

    Clayton, Victoria, 3168

  • Pfizer Investigational Site

    East Bentleigh, Victoria, 3165

  • Pfizer Investigational Site

    St Leonards, New South Wales, 2065

  • Pfizer Investigational Site

    Wollongong, New South Wales, 2500

Other trials in Australia

South Korea4 sites

  • Pfizer Investigational Site

    Seoul, 110-744

  • Pfizer Investigational Site

    Seoul, 135-710

  • Pfizer Investigational Site

    Seoul, 136-705

  • Pfizer Investigational Site

    Seoul, 138-736

Other trials in South Korea

Taiwan3 sites

  • Pfizer Investigational Site

    Kuei-Shan Jsoamg, Taoyuan County, 333

  • Pfizer Investigational Site

    Taichung, 404

  • Pfizer Investigational Site

    Taipei, 112

Other trials in Taiwan

Ireland2 sites

  • Pfizer Investigational Site

    Dublin, 4

  • Pfizer Investigational Site

    Dublin

Other trials in Ireland

Netherlands2 sites

  • Pfizer Investigational Site

    Amsterdam, North Holland, 1105 AZ

  • Pfizer Investigational Site

    Amsterdam, 1081 HV

Other trials in Netherlands

Singapore2 sites

  • Pfizer Investigational Site

    Singapore, Singapore, 119074

  • Pfizer Investigational Site

    Singapore, 16910

Other trials in Singapore

Sweden2 sites

  • Pfizer Investigational Site

    Lund, 221 85

  • Pfizer Investigational Site

    Uppsala, 751 85

Other trials in Sweden

Hong Kong1 site

  • Pfizer Investigational Site

    Shatin, NT

Other trials in Hong Kong

Switzerland1 site

  • Pfizer Investigational Site

    Winterthur, 8401

Other trials in Switzerland

About this study

Official 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.

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.

Read the 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.

Being tested
AG-013736, Gemcitabine, placebo
Keywords
Randomized Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For Advanced Pancreatic Cancer.
Medical subject headings
Carcinoma, Pancreatic Ductal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AG-013736Drug

    oral administration, starting dose 5 mg twice daily [BID] every day until unacceptable toxicity or tumor progression.

  • GemcitabineDrug

    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.

  • GemcitabineDrug

    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.

  • placeboDrug

    placebo

Study groups in NCT00471146
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: AG-013736; Drug: Gemcitabine
BActive comparatorNot described
Receives: Drug: Gemcitabine; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline until death or at least 1 year after the randomization of last participant

Secondary outcomes (9)

  1. 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").

    Measured: Baseline until disease progression or at least 1 year after the randomization of last participant

  2. 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.

    Measured: Baseline, every 8 weeks until tumor progression or death

  3. 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.

    Measured: Baseline until death or at least 1 year after the randomization of last participant

  4. 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.

    Measured: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal

  5. 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.

    Measured: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal

  6. 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.

    Measured: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal

  7. 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.

    Measured: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal

  8. 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.

    Measured: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal

  9. 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.

    Measured: Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionJan 2009
  4. Study completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
630 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00471146
Sponsor's protocol ID
A4061028
Status last verified
Jun 2012
First submitted
7 May 2007
Last updated
16 Jul 2012
Data monitoring committee
Yes

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.

    PubMed 21306953

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AG-013736 and Gemcitabine in people with Carcinoma, Pancreatic Ductal, run by Pfizer at 204 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 204 sites in United States, Canada, United Kingdom, Spain, France and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Baseline until death or at least 1 year after the randomization of last participant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00471146, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2012; AzTrials last refreshed its copy on 7 Nov 2026.

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