GAMMA - Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas
This study has been terminated.
(Due to a pre planned interim analysis by the independent study DMC, it was recommended to stop the study for futility with no safety concerns.)
Sponsor:
Amgen
Collaborator:
Takeda Global Research & Development Center, Inc.
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01231347
First received: October 14, 2010
Last updated: September 19, 2012
Last verified: September 2012
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Purpose
AMG 479 is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important role in the regulation of cell growth and survival.
Gemcitabine is administered on days 1, 8 and 15 of a 28 day cycle, AMG 479 or placebo is administered on days 1 and 15 of the 28 day cycle, both are administered intravenously.
The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine.
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma of the Pancreas Advanced Solid Tumors Cancer Cancer of Pancreas Cancer of the Pancreas Metastases Metastatic Cancer Metastatic Pancreatic Cancer Pancreas Cancer Pancreatic Cancer Bone Metastases Endocrine Cancer Oncology Oncology Patients Solid Tumors Advanced Malignancy |
Drug: AMG 479 Drug: Placebo Drug: gemcitabine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination With Gemcitabine as First Line Therapy for Metastatic Adenocarcinoma of the Pancreas |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- To determine if AMG 479 in combination with gemcitabine improves overall survival as compared with placebo in combination with gemcitabine in subjects with metastatic adenocarcinoma of the pancreas [ Time Frame: After 825 subjects randomized + 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression free survival [ Time Frame: After 825 subjects randomized + 24 months ] [ Designated as safety issue: No ]
- Objective response rate [ Time Frame: After 825 subjects randomized + 24 months ] [ Designated as safety issue: No ]
- Time to disease progression [ Time Frame: After 825 subjects randomized + 24 months ] [ Designated as safety issue: No ]
- Disease control rate [ Time Frame: After 825 subjects randomized + 24 months ] [ Designated as safety issue: No ]
- Number of subjects with adverse events [ Time Frame: After 825 subjects randomized + 24 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 800 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: AMG 479 12 mg/kg dose + gemcitabine
Arm 2: AMG 479 12 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle
|
Drug: AMG 479
AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
Drug: gemcitabine
gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
|
|
Placebo Comparator: Placebo + gemcitabine
Arm 1: AMG 479-placebo IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle
|
Drug: Placebo
Placebo administered intravenously on days 1 and 15 of a 28 day cycle
Drug: gemcitabine
gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
|
|
Active Comparator: AMG 479 20 mg/kg + gemcitabine
Arm 3: AMG 479 20 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle
|
Drug: AMG 479
AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
Drug: gemcitabine
gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Untreated metastatic adenocarcinoma of the pancreas
- Adequate hematologic, renal and liver function
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
Exclusion Criteria:
- Prior chemotherapy or radiotherapy for pancreatic cancer
- Central nervous system metastases
- External biliary drain
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231347
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| United States, California | |
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| Fullerton, California, United States, 92835 | |
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| La Jolla, California, United States, 92093-0957 | |
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| Los Angeles, California, United States, 90095 | |
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| Los Angeles, California, United States, 90095-1772 | |
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| Rancho Mirage, California, United States, 92270 | |
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| Redondo Beach, California, United States, 90277 | |
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| Santa Maria, California, United States, 93454 | |
| United States, Illinois | |
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| Chicago, Illinois, United States, 60637 | |
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| Harvey, Illinois, United States, 60426 | |
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| Quincy, Illinois, United States, 62301 | |
| United States, Massachusetts | |
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| Boston, Massachusetts, United States, 02215 | |
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| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
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| Detroit, Michigan, United States, 48201 | |
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| Grand Rapids, Michigan, United States, 49503 | |
| United States, North Carolina | |
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| Durham, North Carolina, United States, 27710 | |
| United States, Oregon | |
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| Bend, Oregon, United States, 97701 | |
| United States, Rhode Island | |
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| Providence, Rhode Island, United States, 02903 | |
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| Providence, Rhode Island, United States, 02906 | |
| United States, South Carolina | |
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| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
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| Knoxville, Tennessee, United States, 37909 | |
| United States, Texas | |
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| Fort Worth, Texas, United States, 76177 | |
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| Paris, Texas, United States, 75460-5004 | |
| United States, Virginia | |
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| Abingdon, Virginia, United States, 24211 | |
| United States, Washington | |
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| Spokane Valley, Washington, United States, 99216 | |
| Australia, New South Wales | |
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| Kogarah, New South Wales, Australia, 2217 | |
| Australia, Queensland | |
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| South Brisbane, Queensland, Australia, 4101 | |
| Australia, South Australia | |
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| Kurralta Park, South Australia, Australia, 5037 | |
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| Woodville South, South Australia, Australia, 5011 | |
| Australia, Victoria | |
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| Bentleigh East, Victoria, Australia, 3165 | |
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| Parkville, Victoria, Australia, 3050 | |
| Austria | |
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| Innsbruck, Austria, 6020 | |
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| Salzburg, Austria, 5020 | |
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| Steyr, Austria, 4400 | |
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| Wien, Austria, 1090 | |
| Belgium | |
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| Bruxelles, Belgium, 1070 | |
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| Charleroi, Belgium, 6000 | |
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| Edegem, Belgium, 2650 | |
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| Gent, Belgium, 9000 | |
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| Leuven, Belgium, 3000 | |
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| Libramont, Belgium, 6800 | |
| Brazil | |
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| Salvador, Bahia, Brazil, 40050-410 | |
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| Curitba, Paraná, Brazil, 81520-060 | |
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| Porto Alegre, Rio Grande do Sul, Brazil, 90035-003 | |
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| ItajaÃ-, Santa Catarina, Brazil, 88301-220 | |
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| São Paulo, Brazil, 01246-000 | |
| Bulgaria | |
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| Sofia, Bulgaria, 1527 | |
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| Sofia, Bulgaria, 1606 | |
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| Sofia, Bulgaria, 1756 | |
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| Varna, Bulgaria, 9010 | |
| Canada, British Columbia | |
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| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Ontario | |
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| Oshawa, Ontario, Canada, L1G 2B9 | |
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| Ottawa, Ontario, Canada, K1H 8L6 | |
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| Toronto, Ontario, Canada, M5G 2M9 | |
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| Quebec, Canada, G1R 2J6 | |
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| Brno, Czech Republic, 656 53 | |
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| Brno, Czech Republic, 656 91 | |
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| Hradec Kralove, Czech Republic, 500 05 | |
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| Olomouc, Czech Republic, 775 20 | |
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| Praha 2, Czech Republic, 128 08 | |
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| Praha 5, Czech Republic, 150 06 | |
| Denmark | |
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| Aalborg, Denmark, 9000 | |
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| Herlev, Denmark, 2730 | |
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| Odense, Denmark, 5000 | |
| Finland | |
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| HUS, Finland, 00029 | |
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| Lahti, Finland, 15850 | |
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| Tampere, Finland, 33521 | |
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| Turku, Finland, 20521 | |
| France | |
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| Besançon Cedex, France, 25030 | |
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| Brest cedex, France, 29609 | |
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| Clermont Ferrand Cedex 1, France, 63003 | |
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| Pessac Cedex, France, 33604 | |
| Germany | |
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| Berlin, Germany, 13353 | |
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| Dresden, Germany, 01307 | |
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| Halle (Saale), Germany, 06120 | |
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| Mainz, Germany, 55131 | |
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| Mannheim, Germany, 68167 | |
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| Marburg, Germany, 35043 | |
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| Münster, Germany, 48149 | |
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| Villingen-Schwenningen, Germany, 78050 | |
| Greece | |
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| Athens, Greece, 11527 | |
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| Heraklion, Greece, 71110 | |
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| Patra, Greece, 26500 | |
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| Thessaloniki, Greece, 56429 | |
| Hong Kong | |
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| Kowloon, Hong Kong | |
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| Sha Tin, Hong Kong | |
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| Tuen Mun, Hong Kong | |
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| Budapest, Hungary, 1097 | |
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| Budapest, Hungary, 1062 | |
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| Debrecen, Hungary, 4012 | |
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| Gyor, Hungary, 9023 | |
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| Miskolc, Hungary, 3526 | |
| Italy | |
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| Genova, Italy, 16132 | |
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| Messina, Italy, 98125 | |
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| Napoli, Italy, 80131 | |
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| San Giovanni Rotondo FG, Italy, 71013 | |
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| Nagoya-city, Aichi, Japan, 464-8681 | |
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| Kashiwa, Chiba, Japan, 277-8577 | |
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| Yokohama-city, Kanagawa, Japan, 241-0815 | |
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| Sunto-gun, Shizuoka, Japan, 411-8777 | |
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| Mitaka-city, Tokyo, Japan, 181-8611 | |
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| Tokyo, Japan, 104-0045 | |
| Korea, Republic of | |
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| Seoul, Korea, Republic of, 138-736 | |
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| Seoul, Korea, Republic of, 135-710 | |
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| Seoul, Korea, Republic of, 110-744 | |
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| Seoul, Korea, Republic of, 120-752 | |
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| Seoul, Korea, Republic of, 152-703 | |
| Lithuania | |
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| Kaunas, Lithuania, 50009 | |
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| Vilnius, Lithuania, 08660 | |
| Netherlands | |
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| Amsterdam, Netherlands, 1081 HV | |
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| Eindhoven, Netherlands, 5623 EJ | |
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| Groningen, Netherlands, 9713 GZ | |
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| Leiden, Netherlands, 2333 ZA | |
| Poland | |
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| Gdansk, Poland, 80-952 | |
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| Konin, Poland, 62-500 | |
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| Lodz, Poland, 93-509 | |
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| Poznan, Poland, 61-485 | |
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| Warszawa, Poland, 02-097 | |
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| Warszawa, Poland, 04-125 | |
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| Warszawa, Poland, 04-141 | |
| Portugal | |
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| Barreiro, Portugal, 2830-094 | |
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| Lisboa, Portugal, 1649-035 | |
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| Lisboa, Portugal, 1099-023 | |
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| Porto, Portugal, 4200-319 | |
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| Porto, Portugal, 4200-072 | |
| Romania | |
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| Bucharest, Romania, 022328 | |
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| Cluj Napoca, Romania, 400015 | |
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| Cluj-Napoca, Romania, 400015 | |
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| Sibiu, Romania, 550245 | |
| Russian Federation | |
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| Moscow, Russian Federation, 115478 | |
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| Moscow, Russian Federation, 119992 | |
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| Saint Petersburg, Russian Federation, 191104 | |
| Serbia | |
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| Belgrade, Serbia, 11080 | |
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| Belgrade, Serbia, 11000 | |
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| Sremska Kamenica, Serbia, 21204 | |
| Slovakia | |
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| Bardejov, Slovakia, 085 01 | |
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| Bratislava, Slovakia, 833 10 | |
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| Kosice, Slovakia, 041 91 | |
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| Nitra, Slovakia, 950 01 | |
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| Poprad, Slovakia, 058 01 | |
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| Ljubljana, Slovenia, 1000 | |
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| Ljubljana, Slovenia, 1525 | |
| Spain | |
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| Santander, Cantabria, Spain, 39008 | |
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| Badalona, Cataluña, Spain, 08916 | |
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| Barcelona, Cataluña, Spain, 08035 | |
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| Barcelona, Cataluña, Spain, 08036 | |
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| Elche, Comunidad Valenciana, Spain, 03203 | |
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| Valencia, Comunidad Valenciana, Spain, 46010 | |
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| A Coruña, Galicia, Spain, 15006 | |
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| Madrid, Spain, 28050 | |
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| Madrid, Spain, 28034 | |
| Sweden | |
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| Eskilstuna, Sweden, 631 88 | |
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| Linköping, Sweden, 581 85 | |
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| Uppsala, Sweden, 751 85 | |
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| Basel, Switzerland, 4031 | |
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| Geneva 14, Switzerland, 1211 | |
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| Winterthur, Switzerland, 8401 | |
| Taiwan | |
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| Niaosong Township, Kaohsiung, Taiwan, 83301 | |
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| Taipei City, Taipei, Taiwan, 10002 | |
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| Gueishan Township, Taoyuan, Taiwan, 33305 | |
| United Kingdom | |
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| Belfast, United Kingdom, BT9 7AB | |
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| Birmingham, United Kingdom, B9 5SS | |
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| Cottingham, United Kingdom, HU16 5JQ | |
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| Leicester, United Kingdom, LE1 5WW | |
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| Manchester, United Kingdom, M20 4BX | |
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| Northampton, United Kingdom, NN1 5BD | |
Sponsors and Collaborators
Amgen
Takeda Global Research & Development Center, Inc.
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01231347 History of Changes |
| Other Study ID Numbers: | 20060540, 20060540, GAMMA |
| Study First Received: | October 14, 2010 |
| Last Updated: | September 19, 2012 |
| Health Authority: | Canada: Health Canada United States: Dana Farber Cancer Institute IRB United States: Food and Drug Administration United States: Schulman Associates IRB United States: US Oncology Institutional Review Board United States: Western Institutional Review Board Belgium: Centre Hospitalier de l'Ardenne comité d'éthique Brazil: Ministry of Health Greece: National Ethics Committee Japan: Pharmaceuticals and Medical Devices Evaluation Center United State: Western Institutional Review Board Belgium: Commissie Medische Ethiek van de Universitaire Ziekenhuizen KULeuven |
Keywords provided by Amgen:
|
pancreas gemcitabine metastatic jaundice |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Pancreatic Neoplasms Endocrine Gland Neoplasms Bone Neoplasms Bone Marrow Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Cystic, Mucinous, and Serous Neoplastic Processes Pathologic Processes |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Bone Diseases Musculoskeletal Diseases Hematologic Diseases Pancreatin Pancrelipase Gemcitabine Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic |
ClinicalTrials.gov processed this record on May 19, 2013