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

NCT00471146 | Completed Phase 3 Results DMC

• 1 other identifier: A4061028
• Study Type: interventional
• Target: 630
• Locations: 23 countries
• Sites: 200

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.

Conditions

Carcinoma, Pancreatic Ductal

Keywords

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

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (9)

• Progression Free Survival (PFS)

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

• Percentage of Participants With Objective Response (OR)

  Baseline, every 8 weeks until tumor progression or death

• Duration of Response (DR)

  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

  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

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

Study Arms (2)

A

EXPERIMENTAL

Drug: AG-013736; Drug: Gemcitabine

B

ACTIVE COMPARATOR

Drug: Gemcitabine; Drug: placebo

Interventions

AG-013736 DRUG

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

A

Gemcitabine DRUG

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.

A

placebo DRUG

placebo

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (204)

Pfizer Investigational Site

Antioch, California, 94531, United States

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Corona, California, 92878, United States

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Glendora, California, 91741, United States

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La Jolla, California, 92037, United States

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La Jolla, California, 92093, United States

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LaVerne, California, 91750, United States

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Pasadena, California, 91105, United States

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Pleasent Hill, California, 94523, United States

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Pomona, California, 91105, United States

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Pomona, California, 91767, United States

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Rancho Cucamonga, California, 91730, United States

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Rancho Mirage, California, 92270, United States

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Redlands, California, 92374, United States

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San Diego, California, 92103, United States

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San Diego, California, 92161, United States

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San Leandro, California, 94578, United States

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West Covina, California, 91790, United States

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Hollywood, Florida, 33021, United States

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Pembroke Pines, Florida, 33028, United States

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Stuart, Florida, 34994, United States

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Tampa, Florida, 33612, United States

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Atlanta, Georgia, 30309, United States

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Augusta, Georgia, 30901, United States

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Augusta, Georgia, 30909, United States

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Coeur d'Alene, Idaho, 83814, United States

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Alton, Illinois, 62002, United States

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Chicago, Illinois, 60637, United States

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Beech Grove, Indiana, 46107, United States

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Indianapolis, Indiana, 46237, United States

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Indianapolis, Indiana, 46260, United States

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Jeffersonville, Indiana, 47130, United States

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Louisville, Kentucky, 40202, United States

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Louisville, Kentucky, 40207, United States

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Louisville, Kentucky, 40217, United States

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Louisville, Kentucky, 40241, United States

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Shelbyville, Kentucky, 40065, United States

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Baton Rouge, Louisiana, 70806, United States

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Baton Rouge, Louisiana, 70809, United States

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Annapolis, Maryland, 21401, United States

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Burlington, Massachusetts, 01805, United States

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Peabody, Massachusetts, 01960, United States

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Kalamazoo, Michigan, 49007, United States

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Columbus, Mississippi, 39705, United States

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Corinth, Mississippi, 38834, United States

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Southaven, Mississippi, 38671, United States

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Tupelo, Mississippi, 38801, United States

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St Louis, Missouri, 63136, United States

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Billings, Montana, 59101, United States

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Lincoln, Nebraska, 68510, United States

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Las Vegas, Nevada, 89135, United States

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Mineola, New York, 11501, United States

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Syracuse, New York, 13210, United States

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Canton, Ohio, 44718, United States

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Columbus, Ohio, 43214, United States

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Sylvania, Ohio, 43560, United States

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Portland, Oregon, 97227-1191, United States

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Knoxville, Tennessee, 37916, United States

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Knoxville, Tennessee, 37920, United States

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Knoxville, Tennessee, 37934, United States

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Memphis, Tennessee, 38104, United States

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Memphis, Tennessee, 38120, United States

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Austin, Texas, 78705, United States

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Austin, Texas, 78745, United States

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Austin, Texas, 78758, United States

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Austin, Texas, 78759, United States

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Dallas, Texas, 75325-7786, United States

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Dallas, Texas, 75325, United States

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Dallas, Texas, 75390, United States

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Round Rock, Texas, 78664, United States

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Salt Lake City, Utah, 84112, United States

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Lynchburg, Virginia, 24501, United States

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Everett, Washington, 98201, United States

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Federal Way, Washington, 98003, United States

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Kennewick, Washington, 99336, United States

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Lakewood, Washington, 98499, United States

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Puyallup, Washington, 98372, United States

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Tacoma, Washington, 98405, United States

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Bahía Blanca, Buenos Aires, B8000FJI, Argentina

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La Plata, Buenos Aires, B1900AVG, Argentina

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Santa Fe, Santa Fe Province, 3000, Argentina

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Buenos Aires, C1426ANZ, Argentina

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St Leonards, New South Wales, 2065, Australia

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Wollongong, New South Wales, 2500, Australia

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Clayton, Victoria, 3168, Australia

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East Bentleigh, Victoria, 3165, Australia

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Salzburg, A-5020, Austria

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Vienna, 1030, Austria

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Vienna, 1090, Austria

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Vienna, A-1090, Austria

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Wels, A-4600, Austria

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Brussels, 1000, Belgium

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Brussels, 1090, Belgium

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Brussels, 1200, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Wilrijk, 2610, Belgium

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Edmonton, Alberta, T6G 1Z2, Canada

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Kelowna, British Columbia, V1Y 5L3, Canada

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Victoria, British Columbia, V8R 6V5, Canada

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Winnipeg, Manitoba, R2H 2A6, Canada

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Winnipeg, Manitoba, R3E 0V9, Canada

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Moncton, New Brunswick, E1C 6Z8, Canada

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Kingston, Ontario, K7L 2V7, Canada

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Kingston, Ontario, K7L 5P9, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H2X 3J4, Canada

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Montreal, Quebec, H4J 1C5, Canada

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Clichy, 92118, France

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La Chaussée-Saint-Victor, 41260, France

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Marseille, 13385 CEDEX 5, France

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Montpellier, 34298, France

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Paris, 75015, France

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Paris, 75651, France

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Pessac, 33600, France

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Rouen, 76041, France

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Saint-Herblain, 44805, France

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Berlin, 13353, Germany

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Dresden, 01307, Germany

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Essen, 45136, Germany

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Greifswald, 17475, Germany

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Magdeburg, 39130, Germany

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Mannheim, 68167, Germany

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München, 81377, Germany

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Oldenburg, 26133, Germany

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Ulm, 89081, Germany

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Shatin, NT, Hong Kong

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Budapest, 1097, Hungary

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Budapest, 1106, Hungary

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Budapest, 1122, Hungary

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Kaposvár, 7400, Hungary

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Szentes, 6600, Hungary

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Zalaegerszeg, 8900, Hungary

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Ahmedabad, Gujarat, 380 009, India

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Bangalore, Karnataka, 560 078, India

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Kochi, Kerala, 682 304, India

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Andhra, Pradesh, 500 034, India

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Chennai, Tamil Nadu, 600035, India

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Dublin, 4, Ireland

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Dublin, Ireland

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Bologna, 40138, Italy

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Catania, 95122, Italy

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Milan, 20132, Italy

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Milan, 20133, Italy

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Padua, 35128, Italy

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Verona, 37134, Italy

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Nagoya, Aichi-ken, Japan

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Chiba, Chiba, Japan

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Kashiwa-shi, Chiba, Japan

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Fukuoka, Fukuoka, Japan

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Yokohama, Kanagawa, Japan

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Osaka, Osaka, Japan

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Suntougun, Shizuoka, Japan

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Chuo-ku, Tokyo, Japan

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Amsterdam, North Holland, 1105 AZ, Netherlands

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Amsterdam, 1081 HV, Netherlands

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Moscow, Moscow, 129128, Russia

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Moscow, 115478, Russia

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Moscow, 125376, Russia

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Omsk, 644013, Russia

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Saint Petersburg, 191104, Russia

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Saint Petersburg, 198255, Russia

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Sochi, 354057, Russia

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Singapore, Singapore, 119074, Singapore

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Singapore, 16910, Singapore

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Cape Town, 7500, South Africa

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Observatory, 7925, South Africa

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Parktown, 2193, South Africa

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Port Elizabeth, 6001, South Africa

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Pretoria, 0181, South Africa

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Sandton, 2199, South Africa

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Seoul, 110-744, South Korea

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Seoul, 135-710, South Korea

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Seoul, 136-705, South Korea

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Seoul, 138-736, South Korea

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Palma de Mallorca, Balearic Islands, 07198, Spain

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Barcelona, Barcelona, 08035, Spain

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Barcelona, Barcelona, 08036, Spain

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

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Madrid, Madrid, 28046, Spain

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Móstoles, Madrid, 28935, Spain

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Málaga, Malaga, 29010, Spain

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Pamplona, Navarre, 31008, Spain

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Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38320, Spain

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Toledo, Toledo, 45004, Spain

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Lund, 221 85, Sweden

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Uppsala, 751 85, Sweden

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Winterthur, 8401, Switzerland

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Kuei-Shan Jsoamg, Taoyuan County, 333, Taiwan

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Taichung, 404, Taiwan

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Taipei, 112, Taiwan

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Whitchurch, Cardiff, CF14 2TL, United Kingdom

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Maidstone, Kent, ME16 9QQ, United Kingdom

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Leicester, Leicestershire, LE1 5WW, United Kingdom

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Withington, Manchester, M20 4BX, United Kingdom

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Northwood, Middlesex, HA6 2RN, United Kingdom

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Birmingham, B15 2TA, United Kingdom

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Birmingham, B15 2TT, United Kingdom

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Edinburgh, EH4 2XU, United Kingdom

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London, EC1A 7BE, United Kingdom

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London, W12 OHS, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Southhampton, S016 6YD, United Kingdom

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Related Publications (1)

• 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.

  PMID: 21306953 DERIVED

Related Links

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

MeSH Terms

Conditions

Carcinoma, Pancreatic Ductal

Interventions

Axitinib; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2007
• First Posted: May 9, 2007
• Study Start: July 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: November 1, 2010
• Last Updated: July 16, 2012
• Results First Posted: July 16, 2012

Record last verified: 2012-06

Locations

GB (12); IN (5); HK (1); US (77); FR (9); CA (13); AU (5); DE (9); JP (8); RU (7); IT (6); NL (2); HU (6); IE (2); ZA (6); CH (1); AR (4); SG (2); KR (4); BE (6); ES (10); TW (3); SE (2)