Colon Cancer Clinical Trial
ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
Summary
The primary objective of this study is to compare the effect of panitumumab versus cetuximab on overall survival (OS) for chemorefractory metastatic colorectal cancer (mCRC) among patients with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum, metastatic disease
Wild-type KRAS tumor status
Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2
Must have failed a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease
Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of colorectal cancer (CRC)
Adequate hematologic, renal, hepatic and metabolic function
Exclusion Criteria:
Symptomatic brain metastases requiring treatment
Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy), or investigational agent or therapy ≤ 30 days before randomization.
Clinically significant cardiovascular disease
Active infection requiring systemic treatment or any uncontrolled infection ≤14 days prior to randomization
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There are 148 Locations for this study
Stockton California, 95204, United States
Boynton Beach Florida, 33426, United States
Wichita Kansas, 67214, United States
Temple Texas, 76508, United States
Ogden Utah, 84403, United States
Liverpool New South Wales, 2170, Australia
St Leonards New South Wales, 2065, Australia
Wahroonga New South Wales, 2076, Australia
Wollongong New South Wales, 2500, Australia
Woodville South South Australia, 5011, Australia
Ballarat Victoria, 3350, Australia
Box Hill Victoria, 3128, Australia
Epping Victoria, 3076, Australia
Footscray Victoria, 3011, Australia
Heidelberg Victoria, 3084, Australia
Parkville Victoria, 3050, Australia
Edegem , 2650, Belgium
Sofia , 1527, Bulgaria
Sofia , 1784, Bulgaria
Edmonton Alberta, T6G 1, Canada
Halifax Nova Scotia, B3H 2, Canada
Guangzhou Guangdong, 51006, China
Guangzhou Guangdong, 51018, China
Guangzhou Guangdong, 51028, China
Guangzhou Guangdong, 51551, China
Harbin Heilongjiang, 15004, China
Changsha Hunan, 41001, China
Nanjing Jiangsu, 21000, China
Changchun Jilin, 13001, China
XI An Shaanxi, 71006, China
Shanghai Shanghai, 20009, China
Chengdu Sichuan, 61004, China
Chongqing Sichuan, 40003, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31001, China
Beijing , 10002, China
Beijing , 10007, China
Beijing , 10014, China
Shanghai , 20000, China
Shanghai , 20003, China
Shanghai , 20008, China
Tianjin , 30006, China
Horovice , 268 3, Czechia
Nova Ves pod Plesi , 262 0, Czechia
Olomouc , 775 2, Czechia
Praha 10 , 100 3, Czechia
Pribram , 261 0, Czechia
Znojmo , 669 0, Czechia
Besançon Cedex , 25030, France
Montbéliard , 25200, France
Saint Brieuc , 22015, France
Saint Herblain , 44800, France
Villejuif cedex , 94805, France
Kowloon , , Hong Kong
New Territories , , Hong Kong
Hyderabad Andhra Pradesh, 500 0, India
Hyderabad Andhra Pradesh, 500 0, India
Kochi Kerala, 682 3, India
Ahmednagar Maharashtra, 413 7, India
Nagpur Maharashtra, 440 0, India
Nashik Maharashtra, 422 0, India
Nashik Maharashtra, 422 0, India
Pune Maharashtra, 411 0, India
Jaipur Rajasthan, 302 0, India
Chennai Tamil Nadu, 600 0, India
Kolkata West Bengal, 700 0, India
Beer Sheva , 64239, Israel
Jerusalem , 91031, Israel
Kfar Saba , 44281, Israel
Ramat Gan , 52621, Israel
Rehovot , 76100, Israel
Ancona , 60131, Italy
Cesena , 47023, Italy
Cremona , 26100, Italy
Faenza RA , 48018, Italy
Genova , 16132, Italy
Lugo , 48022, Italy
Meldola FC , 47014, Italy
Ravenna , 48100, Italy
Rimini , 47900, Italy
Torino , 10126, Italy
Goyang-si, Gyeonggi-do , 410-7, Korea, Republic of
Seoul , 110-7, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , 136-7, Korea, Republic of
Seoul , 138-7, Korea, Republic of
Daugavpils , 5417, Latvia
Riga , 1002, Latvia
Riga , 1079, Latvia
Kaunas , 50009, Lithuania
Vilnius , 08660, Lithuania
Kota Bharu Kelantan, 16150, Malaysia
Kota Kinabalu Sabah, 88996, Malaysia
Kuala Lumpur Wilayah Persekutuan, 56000, Malaysia
Kuala Lumpur Wilayah Persekutuan, 59100, Malaysia
Rotterdam , 3000 , Netherlands
Lima , 13, Peru
Lima , 34, Peru
Lima , Lima , Peru
Cebu City , 6000, Philippines
Manila , 1000, Philippines
Quezon City , 1102, Philippines
Elblag , 82-30, Poland
Gdansk , 80-21, Poland
Jelenia Gora , 58-50, Poland
Poznan , 61-48, Poland
Szczecin , 71-73, Poland
Warszawa , 02-09, Poland
Warszawa , 02-50, Poland
Warszawa , 02-78, Poland
Bucharest , 02232, Romania
Sibiu , 55024, Romania
Moscow , 11547, Russian Federation
Moscow , 11799, Russian Federation
Saint Petersburg , 19702, Russian Federation
Saint-Petersburg , 19775, Russian Federation
Saint-Petersburg , 19825, Russian Federation
Nis , 18000, Serbia
Sremska Kamenica , 21204, Serbia
Singapore , 11922, Singapore
Singapore , 30843, Singapore
Bardejov , 085 0, Slovakia
Bratislava , 831 0, Slovakia
Nitra , 950 0, Slovakia
Groenkloof Gauteng, 0181, South Africa
Johannesburg Gauteng, 2199, South Africa
Kraaifontein Western Cape, 7570, South Africa
Johannesburg , 2193, South Africa
Port Elizabeth , 6045, South Africa
Göteborg , 416 8, Sweden
Linköping , 581 8, Sweden
Lund , 221 8, Sweden
Uppsala , 751 8, Sweden
Västerås , 721 8, Sweden
Växjö , 351 8, Sweden
Putzu City Chiayi, 61363, Taiwan
Keelung , 20401, Taiwan
Tainan , 70403, Taiwan
Taipei , 11031, Taiwan
Taoyuan , 33305, Taiwan
Belfast , BT9 7, United Kingdom
Bristol , BS2 8, United Kingdom
Cardiff , CF14 , United Kingdom
Guildford , GU2 7, United Kingdom
Leicester , LE1 5, United Kingdom
London , SW17 , United Kingdom
Maidstone , ME16 , United Kingdom
Manchester , M20 4, United Kingdom
Oxford , OX3 7, United Kingdom
Sutton , SM2 5, United Kingdom
Wolverhampton , WV10 , United Kingdom
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