Cancer Clinical Trial
— GAMMAOfficial 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
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.
| Status | Terminated |
| Enrollment | 800 |
| Est. completion date | December 2012 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Research Site | Bentleigh East | Victoria |
| Australia | Research Site | Kogarah | New South Wales |
| Australia | Research Site | Kurralta Park | South Australia |
| Australia | Research Site | Parkville | Victoria |
| Australia | Research Site | South Brisbane | Queensland |
| Australia | Research Site | Woodville South | South Australia |
| Austria | Research Site | Innsbruck | |
| Austria | Research Site | Salzburg | |
| Austria | Research Site | Steyr | |
| Austria | Research Site | Wien | |
| Belgium | Research Site | Bruxelles | |
| Belgium | Research Site | Charleroi | |
| Belgium | Research Site | Edegem | |
| Belgium | Research Site | Gent | |
| Belgium | Research Site | Leuven | |
| Belgium | Research Site | Libramont | |
| Brazil | Research Site | Curitba | Paraná |
| Brazil | Research Site | ItajaÃ- | Santa Catarina |
| Brazil | Research Site | Porto Alegre | Rio Grande do Sul |
| Brazil | Research Site | São Paulo | |
| Brazil | Research Site | Salvador | Bahia |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Varna | |
| Canada | Research Site | Oshawa | Ontario |
| Canada | Research Site | Ottawa | Ontario |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Vancouver | British Columbia |
| Czech Republic | Research Site | Brno | |
| Czech Republic | Research Site | Brno | |
| Czech Republic | Research Site | Hradec Kralove | |
| Czech Republic | Research Site | Olomouc | |
| Czech Republic | Research Site | Praha 2 | |
| Czech Republic | Research Site | Praha 5 | |
| Denmark | Research Site | Aalborg | |
| Denmark | Research Site | Herlev | |
| Denmark | Research Site | Odense | |
| Finland | Research Site | HUS | |
| Finland | Research Site | Lahti | |
| Finland | Research Site | Tampere | |
| Finland | Research Site | Turku | |
| France | Research Site | Besançon Cedex | |
| France | Research Site | Brest cedex | |
| France | Research Site | Clermont Ferrand Cedex 1 | |
| France | Research Site | Pessac Cedex | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Dresden | |
| Germany | Research Site | Halle (Saale) | |
| Germany | Research Site | Münster | |
| Germany | Research Site | Mainz | |
| Germany | Research Site | Mannheim | |
| Germany | Research Site | Marburg | |
| Germany | Research Site | Villingen-Schwenningen | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Heraklion | |
| Greece | Research Site | Patra | |
| Greece | Research Site | Thessaloniki | |
| Hong Kong | Research Site | Kowloon | |
| Hong Kong | Research Site | Sha Tin | |
| Hong Kong | Research Site | Tuen Mun | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Debrecen | |
| Hungary | Research Site | Gyor | |
| Hungary | Research Site | Miskolc | |
| Italy | Research Site | Genova | |
| Italy | Research Site | Messina | |
| Italy | Research Site | Napoli | |
| Italy | Research Site | San Giovanni Rotondo FG | |
| Japan | Research Site | Kashiwa | Chiba |
| Japan | Research Site | Mitaka-city | Tokyo |
| Japan | Research Site | Nagoya-city | Aichi |
| Japan | Research Site | Sunto-gun | Shizuoka |
| Japan | Research Site | Tokyo | |
| Japan | Research Site | Yokohama-city | Kanagawa |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Lithuania | Research Site | Kaunas | |
| Lithuania | Research Site | Vilnius | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Eindhoven | |
| Netherlands | Research Site | Groningen | |
| Netherlands | Research Site | Leiden | |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Konin | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Warszawa | |
| Portugal | Research Site | Barreiro | |
| Portugal | Research Site | Lisboa | |
| Portugal | Research Site | Lisboa | |
| Portugal | Research Site | Porto | |
| Portugal | Research Site | Porto | |
| Romania | Research Site | Bucharest | |
| Romania | Research Site | Cluj Napoca | |
| Romania | Research Site | Cluj-Napoca | |
| Romania | Research Site | Sibiu | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Saint Petersburg | |
| Serbia | Research Site | Belgrade | |
| Serbia | Research Site | Belgrade | |
| Serbia | Research Site | Sremska Kamenica | |
| Slovakia | Research Site | Bardejov | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Kosice | |
| Slovakia | Research Site | Nitra | |
| Slovakia | Research Site | Poprad | |
| Slovenia | Research Site | Ljubljana | |
| Slovenia | Research Site | Ljubljana | |
| Spain | Research Site | A Coruña | Galicia |
| Spain | Research Site | Badalona | Cataluña |
| Spain | Research Site | Barcelona | Cataluña |
| Spain | Research Site | Barcelona | Cataluña |
| Spain | Research Site | Elche | Comunidad Valenciana |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Santander | Cantabria |
| Spain | Research Site | Valencia | Comunidad Valenciana |
| Sweden | Research Site | Eskilstuna | |
| Sweden | Research Site | Linköping | |
| Sweden | Research Site | Uppsala | |
| Switzerland | Research Site | Basel | |
| Switzerland | Research Site | Geneva 14 | |
| Switzerland | Research Site | Winterthur | |
| Taiwan | Research Site | Gueishan Township | Taoyuan |
| Taiwan | Research Site | Niaosong Township | Kaohsiung |
| Taiwan | Research Site | Taipei City | Taipei |
| United Kingdom | Research Site | Belfast | |
| United Kingdom | Research Site | Birmingham | |
| United Kingdom | Research Site | Cottingham | |
| United Kingdom | Research Site | Leicester | |
| United Kingdom | Research Site | Manchester | |
| United Kingdom | Research Site | Northampton | |
| United States | Research Site | Abingdon | Virginia |
| United States | Research Site | Bend | Oregon |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Detroit | Michigan |
| United States | Research Site | Durham | North Carolina |
| United States | Research Site | Fort Worth | Texas |
| United States | Research Site | Fullerton | California |
| United States | Research Site | Grand Rapids | Michigan |
| United States | Research Site | Harvey | Illinois |
| United States | Research Site | Knoxville | Tennessee |
| United States | Research Site | La Jolla | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Paris | Texas |
| United States | Research Site | Providence | Rhode Island |
| United States | Research Site | Providence | Rhode Island |
| United States | Research Site | Quincy | Illinois |
| United States | Research Site | Rancho Mirage | California |
| United States | Research Site | Redondo Beach | California |
| United States | Research Site | Santa Maria | California |
| United States | Research Site | Spokane Valley | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| NantCell, Inc. | Takeda |
United States, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Republic of, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Kingdom,
Fuchs CS, Azevedo S, Okusaka T, Van Laethem JL, Lipton LR, Riess H, Szczylik C, Moore MJ, Peeters M, Bodoky G, Ikeda M, Melichar B, Nemecek R, Ohkawa S, Swieboda-Sadlej A, Tjulandin SA, Van Cutsem E, Loberg R, Haddad V, Gansert JL, Bach BA, Carrato A. A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial. Ann Oncol. 2015 May;26(5):921-7. doi: 10.1093/annonc/mdv027. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | After 825 subjects randomized + 24 months | No | |
| Secondary | Progression free survival | After 825 subjects randomized + 24 months | No | |
| Secondary | Objective response rate | After 825 subjects randomized + 24 months | No | |
| Secondary | Time to disease progression | After 825 subjects randomized + 24 months | No | |
| Secondary | Disease control rate | After 825 subjects randomized + 24 months | No | |
| Secondary | Number of subjects with adverse events | After 825 subjects randomized + 24 months | Yes |
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