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.

View Eligibility Criteria

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

Study is for people with:

Colon Cancer

Phase:

Phase 3

Estimated Enrollment:

1010

Study ID:

NCT01001377

Recruitment Status:

Completed

Sponsor:

Amgen

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There are 148 Locations for this study

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Stockton California, 95204, United States
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Boynton Beach Florida, 33426, United States
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Wichita Kansas, 67214, United States
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Temple Texas, 76508, United States
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Ogden Utah, 84403, United States
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Liverpool New South Wales, 2170, Australia
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St Leonards New South Wales, 2065, Australia
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Wahroonga New South Wales, 2076, Australia
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Wollongong New South Wales, 2500, Australia
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Woodville South South Australia, 5011, Australia
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Ballarat Victoria, 3350, Australia
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Box Hill Victoria, 3128, Australia
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Epping Victoria, 3076, Australia
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Footscray Victoria, 3011, Australia
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Heidelberg Victoria, 3084, Australia
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Parkville Victoria, 3050, Australia
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Edegem , 2650, Belgium
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Sofia , 1527, Bulgaria
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Sofia , 1784, Bulgaria
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Edmonton Alberta, T6G 1, Canada
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Halifax Nova Scotia, B3H 2, Canada
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Guangzhou Guangdong, 51006, China
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Guangzhou Guangdong, 51018, China
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Guangzhou Guangdong, 51028, China
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Guangzhou Guangdong, 51551, China
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Harbin Heilongjiang, 15004, China
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Changsha Hunan, 41001, China
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Nanjing Jiangsu, 21000, China
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Changchun Jilin, 13001, China
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XI An Shaanxi, 71006, China
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Shanghai Shanghai, 20009, China
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Chengdu Sichuan, 61004, China
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Chongqing Sichuan, 40003, China
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Hangzhou Zhejiang, 31000, China
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Hangzhou Zhejiang, 31001, China
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Beijing , 10002, China
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Beijing , 10007, China
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Beijing , 10014, China
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Shanghai , 20000, China
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Shanghai , 20003, China
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Shanghai , 20008, China
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Tianjin , 30006, China
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Horovice , 268 3, Czechia
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Nova Ves pod Plesi , 262 0, Czechia
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Olomouc , 775 2, Czechia
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Praha 10 , 100 3, Czechia
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Pribram , 261 0, Czechia
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Znojmo , 669 0, Czechia
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Besançon Cedex , 25030, France
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Montbéliard , 25200, France
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Saint Brieuc , 22015, France
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Saint Herblain , 44800, France
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Villejuif cedex , 94805, France
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Kowloon , , Hong Kong
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New Territories , , Hong Kong
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Hyderabad Andhra Pradesh, 500 0, India
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Hyderabad Andhra Pradesh, 500 0, India
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Kochi Kerala, 682 3, India
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Ahmednagar Maharashtra, 413 7, India
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Nagpur Maharashtra, 440 0, India
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Nashik Maharashtra, 422 0, India
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Nashik Maharashtra, 422 0, India
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Pune Maharashtra, 411 0, India
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Jaipur Rajasthan, 302 0, India
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Chennai Tamil Nadu, 600 0, India
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Kolkata West Bengal, 700 0, India
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Beer Sheva , 64239, Israel
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Jerusalem , 91031, Israel
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Kfar Saba , 44281, Israel
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Ramat Gan , 52621, Israel
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Rehovot , 76100, Israel
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Ancona , 60131, Italy
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Cesena , 47023, Italy
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Cremona , 26100, Italy
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Faenza RA , 48018, Italy
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Genova , 16132, Italy
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Lugo , 48022, Italy
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Meldola FC , 47014, Italy
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Ravenna , 48100, Italy
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Rimini , 47900, Italy
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Torino , 10126, Italy
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Goyang-si, Gyeonggi-do , 410-7, Korea, Republic of
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Seoul , 110-7, Korea, Republic of
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Seoul , 120-7, Korea, Republic of
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Seoul , 135-7, Korea, Republic of
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Seoul , 136-7, Korea, Republic of
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Seoul , 138-7, Korea, Republic of
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Daugavpils , 5417, Latvia
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Riga , 1002, Latvia
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Riga , 1079, Latvia
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Kaunas , 50009, Lithuania
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Vilnius , 08660, Lithuania
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Kota Bharu Kelantan, 16150, Malaysia
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Kota Kinabalu Sabah, 88996, Malaysia
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Kuala Lumpur Wilayah Persekutuan, 56000, Malaysia
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Kuala Lumpur Wilayah Persekutuan, 59100, Malaysia
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Rotterdam , 3000 , Netherlands
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Lima , 13, Peru
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Lima , 34, Peru
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Lima , Lima , Peru
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Cebu City , 6000, Philippines
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Manila , 1000, Philippines
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Quezon City , 1102, Philippines
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Elblag , 82-30, Poland
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Gdansk , 80-21, Poland
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Jelenia Gora , 58-50, Poland
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Poznan , 61-48, Poland
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Szczecin , 71-73, Poland
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Warszawa , 02-09, Poland
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Warszawa , 02-50, Poland
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Warszawa , 02-78, Poland
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Bucharest , 02232, Romania
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Sibiu , 55024, Romania
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Moscow , 11547, Russian Federation
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Moscow , 11799, Russian Federation
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Saint Petersburg , 19702, Russian Federation
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Saint-Petersburg , 19775, Russian Federation
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Saint-Petersburg , 19825, Russian Federation
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Nis , 18000, Serbia
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Sremska Kamenica , 21204, Serbia
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Singapore , 11922, Singapore
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Singapore , 30843, Singapore
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Bardejov , 085 0, Slovakia
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Bratislava , 831 0, Slovakia
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Nitra , 950 0, Slovakia
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Groenkloof Gauteng, 0181, South Africa
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Johannesburg Gauteng, 2199, South Africa
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Kraaifontein Western Cape, 7570, South Africa
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Johannesburg , 2193, South Africa
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Port Elizabeth , 6045, South Africa
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Göteborg , 416 8, Sweden
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Linköping , 581 8, Sweden
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Lund , 221 8, Sweden
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Uppsala , 751 8, Sweden
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Västerås , 721 8, Sweden
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Växjö , 351 8, Sweden
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Putzu City Chiayi, 61363, Taiwan
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Keelung , 20401, Taiwan
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Tainan , 70403, Taiwan
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Taipei , 11031, Taiwan
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Taoyuan , 33305, Taiwan
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Belfast , BT9 7, United Kingdom
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Bristol , BS2 8, United Kingdom
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Cardiff , CF14 , United Kingdom
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Guildford , GU2 7, United Kingdom
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Leicester , LE1 5, United Kingdom
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London , SW17 , United Kingdom
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Maidstone , ME16 , United Kingdom
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Manchester , M20 4, United Kingdom
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Oxford , OX3 7, United Kingdom
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Sutton , SM2 5, United Kingdom
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Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 3

Estimated Enrollment:

1010

Study ID:

NCT01001377

Recruitment Status:

Completed

Sponsor:


Amgen

How clear is this clinincal trial information?

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