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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00471146 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Pancreatic Ductal |
Drug: AG-013736 Drug: Gemcitabine Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy 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. |
| Estimated Enrollment: | 632 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | September 2010 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| A: Experimental |
Drug: AG-013736
oral administration, starting dose 5 mg BID every day until unacceptable toxicity or tumor progression.
Drug: Gemcitabine
intravenous administration at 1,000 mg/m2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.
|
| B: Active Comparator |
Drug: Gemcitabine
intravenous administration at 1,000 mg/m2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.
Drug: placebo
placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, California | |
| Pfizer Investigational Site | |
| La Jolla, California, United States, 92037 | |
| Pfizer Investigational Site | |
| La Jolla, California, United States, 92093 | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92103 | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92161 | |
| Pfizer Investigational Site | |
| Antioch, California, United States, 94531 | |
| Pfizer Investigational Site | |
| Pleasent Hill, California, United States, 94523 | |
| Pfizer Investigational Site | |
| Pasadena, California, United States, 91105 | |
| Pfizer Investigational Site | |
| Corona, California, United States, 92878 | |
| Pfizer Investigational Site | |
| Glendora, California, United States, 91741 | |
| Pfizer Investigational Site | |
| LaVerne, California, United States, 91750 | |
| Pfizer Investigational Site | |
| Pamona, California, United States, 91105 | |
| Pfizer Investigational Site | |
| San Leandro, California, United States, 94578 | |
| Pfizer Investigational Site | |
| Rancho Cucamonga, California, United States, 91730 | |
| Pfizer Investigational Site | |
| West Covina, California, United States, 91790 | |
| Pfizer Investigational Site | |
| Pomona, California, United States, 91767 | |
| Pfizer Investigational Site | |
| Rancho Mirage, California, United States, 92270 | |
| Pfizer Investigational Site | |
| Redlands, California, United States, 92374 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33612 | |
| Pfizer Investigational Site | |
| Hollywood, Florida, United States, 33021 | |
| Pfizer Investigational Site | |
| Pembroke Pines, Florida, United States, 33028 | |
| Pfizer Investigational Site | |
| Stuart, Florida, United States, 34994 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30309 | |
| Pfizer Investigational Site | |
| Augusta, Georgia, United States, 30901 | |
| Pfizer Investigational Site | |
| Augusta, Georgia, United States, 30909 | |
| United States, Idaho | |
| Pfizer Investigational Site | |
| Coeur D'Alene, Idaho, United States, 83814 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60637 | |
| Pfizer Investigational Site | |
| Alton, Illinois, United States, 62002 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Jeffersonville, Indiana, United States, 47130 | |
| Pfizer Investigational Site | |
| Beech Grove, Indiana, United States, 46107 | |
| Pfizer Investigational Site | |
| Indianapolis, Indiana, United States, 46237 | |
| Pfizer Investigational Site | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Louisville, Kentucky, United States, 40202 | |
| Pfizer Investigational Site | |
| Louisville, Kentucky, United States, 40207 | |
| Pfizer Investigational Site | |
| Louisville, Kentucky, United States, 40217 | |
| Pfizer Investigational Site | |
| Louisville, Kentucky, United States, 40241 | |
| Pfizer Investigational Site | |
| Shelbyville, Kentucky, United States, 40065 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Baton Rouge, Louisiana, United States, 70806 | |
| Pfizer Investigational Site | |
| Baton Rouge, Louisiana, United States, 70809 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Annapolis, Maryland, United States, 21401 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Burlington, Massachusetts, United States, 01805 | |
| Pfizer Investigational Site | |
| Peabody, Massachusetts, United States, 01960 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Kalamazoo, Michigan, United States, 49007 | |
| United States, Mississippi | |
| Pfizer Investigational Site | |
| Tupelo, Mississippi, United States, 38801 | |
| Pfizer Investigational Site | |
| Corinth, Mississippi, United States, 38834 | |
| Pfizer Investigational Site | |
| Columbus, Mississippi, United States, 39705 | |
| Pfizer Investigational Site | |
| Southaven, Mississippi, United States, 38671 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63136 | |
| United States, Montana | |
| Pfizer Investigational Site | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| Pfizer Investigational Site | |
| Lincoln, Nebraska, United States, 68510 | |
| United States, Nevada | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89135 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Syracuse, New York, United States, 13210 | |
| Pfizer Investigational Site | |
| Mineola, New York, United States, 11501 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Sylvania, Ohio, United States, 43560 | |
| Pfizer Investigational Site | |
| Columbus, Ohio, United States, 43214 | |
| Pfizer Investigational Site | |
| Canton, Ohio, United States, 44718 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Portland, Oregon, United States, 97227-1191 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Knoxville, Tennessee, United States, 37916 | |
| Pfizer Investigational Site | |
| Knoxville, Tennessee, United States, 37920 | |
| Pfizer Investigational Site | |
| Knoxville, Tennessee, United States, 37934 | |
| Pfizer Investigational Site | |
| Memphis, Tennessee, United States, 38104 | |
| Pfizer Investigational Site | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75325 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75325-7786 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75390 | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78705 | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78745 | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78758 | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78759 | |
| Pfizer Investigational Site | |
| Round Rock, Texas, United States, 78664 | |
| United States, Utah | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84112 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Lynchburg, Virginia, United States, 24501 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| Pfizer Investigational Site | |
| Everett, Washington, United States, 98201 | |
| Pfizer Investigational Site | |
| Federal Way, Washington, United States, 98003 | |
| Pfizer Investigational Site | |
| Lakewood, Washington, United States, 98499 | |
| Pfizer Investigational Site | |
| Puyallup, Washington, United States, 98372 | |
| Pfizer Investigational Site | |
| Kennewick, Washington, United States, 99336 | |
| Argentina | |
| Pfizer Investigational Site | |
| Ciudad Autonoma de Buenos Aires, Argentina, C1426ANZ | |
| Pfizer Investigational Site | |
| Santa Fe, Argentina, 3000 | |
| Argentina, Buenos Aires | |
| Pfizer Investigational Site | |
| Bahia Blanca, Buenos Aires, Argentina, B8000FJI | |
| Pfizer Investigational Site | |
| La Plata, Buenos Aires, Argentina, B1900AVG | |
| Australia, New South Wales | |
| Pfizer Investigational Site | |
| St. Leonards, New South Wales, Australia, 2065 | |
| Pfizer Investigational Site | |
| Wollongong, New South Wales, Australia, 2500 | |
| Australia, Victoria | |
| Pfizer Investigational Site | |
| Clayton, Victoria, Australia, 3168 | |
| Pfizer Investigational Site | |
| East Bentleigh, Victoria, Australia, 3165 | |
| Austria | |
| Pfizer Investigational Site | |
| 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 | |
| Belgium | |
| Pfizer Investigational Site | |
| Bruxelles, Belgium, 1200 | |
| Pfizer Investigational Site | |
| Bruxelles, Belgium, 1000 | |
| Pfizer Investigational Site | |
| Leuven, Belgium, 3000 | |
| Pfizer Investigational Site | |
| Gent, Belgium, 9000 | |
| Pfizer Investigational Site | |
| Wilrijk, Belgium, 2610 | |
| Pfizer Investigational Site | |
| Brussel, Belgium, 1090 | |
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, British Columbia | |
| Pfizer Investigational Site | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| Pfizer Investigational Site | |
| Victoria, British Columbia, Canada, V8R 6V5 | |
| Canada, Manitoba | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, New Brunswick | |
| Pfizer Investigational Site | |
| Moncton, New Brunswick, Canada, E1C 6Z8 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Pfizer Investigational Site | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Pfizer Investigational Site | |
| Oshawa, Ontario, Canada, L1G 2B9 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H2X 3J4 | |
| France | |
| Pfizer Investigational Site | |
| Rouen, France, 76041 | |
| Pfizer Investigational Site | |
| Marseille, France, 13385 CEDEX 5 | |
| Pfizer Investigational Site | |
| Paris Cedex 13, France, 75651 | |
| Pfizer Investigational Site | |
| St Herblain Cedex, France, 44805 | |
| Pfizer Investigational Site | |
| Montpellier Cedex 02, France, 34298 | |
| Pfizer Investigational Site | |
| La Chaussee Saint Victor, France, 41260 | |
| Pfizer Investigational Site | |
| Clichy Cedex, France, 92118 | |
| Pfizer Investigational Site | |
| Paris, France, 75015 | |
| Pfizer Investigational Site | |
| Pessac Cedex, France, 33600 | |
| Germany | |
| Pfizer Investigational Site | |
| Muenchen, Germany, 81377 | |
| Pfizer Investigational Site | |
| Mannheim, Germany, 68167 | |
| Pfizer Investigational Site | |
| Magdeburg, Germany, 39130 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 13353 | |
| Pfizer Investigational Site | |
| Ulm, Germany, 89081 | |
| Pfizer Investigational Site | |
| Essen, Germany, 45136 | |
| Pfizer Investigational Site | |
| Greifswald, Germany, 17475 | |
| Pfizer Investigational Site | |
| Oldenburg, Germany, 26133 | |
| Pfizer Investigational Site | |
| Dresden, Germany, 01307 | |
| Hong Kong, NT | |
| Pfizer Investigational Site | |
| Shatin, NT, Hong Kong | |
| Hungary | |
| Pfizer Investigational Site | |
| Budapest, Hungary, 1122 | |
| Pfizer Investigational Site | |
| Budapest, Hungary, 1106 | |
| Pfizer Investigational Site | |
| Szentes, Hungary, 6600 | |
| Pfizer Investigational Site | |
| Kaposvar, Hungary, 7400 | |
| Pfizer Investigational Site | |
| Zalaegerszeg, Hungary, 8900 | |
| Pfizer Investigational Site | |
| Budapest, Hungary, 1097 | |
| India, GUJARAT | |
| Pfizer Investigational Site | |
| Ahmedabad, GUJARAT, India, 380 009 | |
| India, Karnataka | |
| Pfizer Investigational Site | |
| Bangalore, Karnataka, India, 560 078 | |
| India, Kerala | |
| Pfizer Investigational Site | |
| Cochin, Kerala, India, 682 304 | |
| India, Pradesh | |
| Pfizer Investigational Site | |
| Andhra, Pradesh, India, 500 034 | |
| India, Tamil Nadu | |
| Pfizer Investigational Site | |
| Chennai, Tamil Nadu, India, 600035 | |
| Ireland | |
| Pfizer Investigational Site | |
| Dublin 24, Ireland | |
| Pfizer Investigational Site | |
| Dublin, Ireland, 4 | |
| Italy | |
| Pfizer Investigational Site | |
| Milano, Italy, 20133 | |
| Pfizer Investigational Site | |
| Catania, Italy, 95122 | |
| Pfizer Investigational Site | |
| Milano, Italy, 20132 | |
| Pfizer Investigational Site | |
| Padova, Italy, 35128 | |
| Pfizer Investigational Site | |
| Bologna, Italy, 40138 | |
| Pfizer Investigational Site | |
| Verona, Italy, 37134 | |
| Japan, Aichi | |
| Pfizer Investigational Site | |
| Nagoya, Aichi, Japan | |
| Japan, Chiba | |
| Pfizer Investigational Site | |
| Kashiwa-shi, Chiba, Japan | |
| Pfizer Investigational Site | |
| Chiba City, Chiba, Japan | |
| Japan, Chiba-ken | |
| Pfizer Investigational Site | |
| Chiba-shi, Chiba-ken, Japan | |
| Japan, Fukuoka-ken | |
| Pfizer Investigational Site | |
| Fukuoka-shi, Fukuoka-ken, Japan | |
| Japan, Kanagawa | |
| Pfizer Investigational Site | |
| Yokohama-shi, Kanagawa, Japan | |
| Japan, Osaka-fu | |
| Pfizer Investigational Site | |
| Osaka-shi, Osaka-fu, Japan | |
| Japan, Shizuoka | |
| Pfizer Investigational Site | |
| Suntougun, Shizuoka, Japan | |
| Japan, Tokyo | |
| Pfizer Investigational Site | |
| Chuo-ku, Tokyo, Japan | |
| Korea, Republic of | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 136-705 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 138-736 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 135-710 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 110-744 | |
| Netherlands | |
| Pfizer Investigational Site | |
| Amsterdam, Netherlands, 1081 HV | |
| Netherlands, Noord Holland | |
| Pfizer Investigational Site | |
| Amsterdam, Noord Holland, Netherlands, 1105 AZ | |
| Russian Federation | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 115478 | |
| Pfizer Investigational Site | |
| St. Petersburg, Russian Federation, 198255 | |
| Pfizer Investigational Site | |
| St. Petersburg, Russian Federation, 191104 | |
| Pfizer Investigational Site | |
| Sochi, Russian Federation, 354057 | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 125376 | |
| Pfizer Investigational Site | |
| Omsk, Russian Federation, 644013 | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 129128 | |
| Singapore | |
| Pfizer Investigational Site | |
| Singapore, Singapore, 16910 | |
| Pfizer Investigational Site | |
| Singapore, Singapore, 119074 | |
| South Africa | |
| Pfizer Investigational Site | |
| Cape Town, South Africa, 7500 | |
| Pfizer Investigational Site | |
| Port Elizabeth, South Africa, 6001 | |
| Pfizer Investigational Site | |
| Sandton, South Africa, 2199 | |
| Pfizer Investigational Site | |
| Observatory, South Africa, 7925 | |
| Pfizer Investigational Site | |
| Pretoria, South Africa, 0181 | |
| Pfizer Investigational Site | |
| Parktown, South Africa, 2193 | |
| Spain | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08036 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08035 | |
| 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 | |
| Spain, Islas Baleares | |
| Pfizer Investigational Site | |
| Palma de Mallorca, Islas Baleares, Spain, 07198 | |
| Spain, Madrid | |
| Pfizer Investigational Site | |
| Mostoles, Madrid, Spain, 28935 | |
| Spain, NAVARRA | |
| Pfizer Investigational Site | |
| Pamplona, NAVARRA, Spain, 31008 | |
| Sweden | |
| Pfizer Investigational Site | |
| Uppsala, Sweden, 751 85 | |
| Pfizer Investigational Site | |
| Lund, Sweden, 221 85 | |
| Switzerland | |
| Pfizer Investigational Site | |
| Winterthur, Switzerland, 8401 | |
| Taiwan | |
| Pfizer Investigational Site | |
| Taipei, Taiwan, 112 | |
| Pfizer Investigational Site | |
| Taichung, Taiwan, 404 | |
| Taiwan, Taoyuan County | |
| Pfizer Investigational Site | |
| Kuei-Shan Jsoamg, Taoyuan County, Taiwan, 333 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| London, United Kingdom, EC1A 7BE | |
| Pfizer Investigational Site | |
| Southhampton, United Kingdom, S016 6YD | |
| Pfizer Investigational Site | |
| Manchester, United Kingdom, M20 4BX | |
| Pfizer Investigational Site | |
| Edinburgh, United Kingdom, EH4 2XU | |
| Pfizer Investigational Site | |
| London, United Kingdom, W12 OHS | |
| Pfizer Investigational Site | |
| Birmingham, United Kingdom, B15 2TA | |
| Pfizer Investigational Site | |
| Birmingham, United Kingdom, B15 2TT | |
| United Kingdom, Cardiff | |
| Pfizer Investigational Site | |
| Whitchurch, Cardiff, United Kingdom, CF14 2TL | |
| United Kingdom, Kent | |
| Pfizer Investigational Site | |
| Maidstone, Kent, United Kingdom, ME16 9QQ | |
| United Kingdom, Leicestershire | |
| Pfizer Investigational Site | |
| Leicester, Leicestershire, United Kingdom, LE1 5WW | |
| United Kingdom, Manchester | |
| Pfizer Investigational Site | |
| Withington, Manchester, United Kingdom, M20 4BX | |
| United Kingdom, Middlesex | |
| Pfizer Investigational Site | |
| Northwood, Middlesex, United Kingdom, HA6 2RN | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A4061028 |
| Study First Received: | May 7, 2007 |
| Last Updated: | November 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00471146 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Randomized Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For Advanced Pancreatic Cancer. |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Carcinoma, Pancreatic Ductal Neoplasms by Site Therapeutic Uses Gemcitabine Endocrine Gland Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type |
Endocrine System Diseases Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Carcinoma Carcinoma, Ductal Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Pancreatic Diseases Neoplasms, Ductal, Lobular, and Medullary Adenocarcinoma Neoplasms, Glandular and Epithelial |
