ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
NCT ID: NCT01001377
Last Updated: 2022-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1010 participants
INTERVENTIONAL
2010-02-02
2017-03-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cetuximab
Cetuximab 400 mg/m\^2 as an initial dose, followed by 250 mg/m\^2 intravenously (IV) every 7 days.
Participants were treated until disease progression, intolerability, withdrawal of consent, or death.
Cetuximab
Administered by intravenous infusion
Panitumumab
Panitumumab 6 mg/kg IV every 14 days. Participants were treated until disease progression, intolerability, withdrawal of consent, or death.
Panitumumab
Administered by intravenous infusion
Interventions
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Cetuximab
Administered by intravenous infusion
Panitumumab
Administered by intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Stockton, California, United States
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Boynton Beach, Florida, United States
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Wichita, Kansas, United States
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Temple, Texas, United States
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Ogden, Utah, United States
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Liverpool, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Wahroonga, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Woodville South, South Australia, Australia
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Ballarat, Victoria, Australia
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Box Hill, Victoria, Australia
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Epping, Victoria, Australia
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Footscray, Victoria, Australia
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Heidelberg, Victoria, Australia
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Parkville, Victoria, Australia
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Edegem, , Belgium
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Guangzhou, Guangdong, China
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Guangzhou, Guangdong, China
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Guangzhou, Guangdong, China
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Guangzhou, Guangdong, China
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Harbin, Heilongjiang, China
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Changsha, Hunan, China
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Nanjing, Jiangsu, China
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Changchun, Jilin, China
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Xi'an, Shaanxi, China
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Shanghai, Shanghai Municipality, China
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Chengdu, Sichuan, China
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Chongqing, Sichuan, China
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Hangzhou, Zhejiang, China
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Hangzhou, Zhejiang, China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Shanghai, , China
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Shanghai, , China
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Shanghai, , China
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Tianjin, , China
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Hořovice, , Czechia
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Nová Ves pod Pleší, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Příbram, , Czechia
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Znojmo, , Czechia
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Besançon, , France
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Montbéliard, , France
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Saint-Brieuc, , France
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Saint-Herblain, , France
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Villejuif, , France
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Kowloon, , Hong Kong
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New Territories, , Hong Kong
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Hyderabad, Andhra Pradesh, India
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Hyderabad, Andhra Pradesh, India
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Kochi, Kerala, India
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Ahilyanagar, Maharashtra, India
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Nagpur, Maharashtra, India
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Nashik, Maharashtra, India
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Nashik, Maharashtra, India
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Pune, Maharashtra, India
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Jaipur, Rajasthan, India
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Chennai, Tamil Nadu, India
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Kolkata, West Bengal, India
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Beersheba, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Ramat Gan, , Israel
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Rehovot, , Israel
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Ancona, , Italy
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Cesena, , Italy
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Cremona, , Italy
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Faenza RA, , Italy
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Genova, , Italy
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Lugo, , Italy
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Meldola FC, , Italy
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Ravenna, , Italy
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Rimini, , Italy
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Torino, , Italy
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Daugavpils, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Kaunas, , Lithuania
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Vilnius, , Lithuania
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Kota Bharu, Kelantan, Malaysia
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Kuala Lumpur, Kuala Lumpur, Malaysia
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Kuala Lumpur, Kuala Lumpur, Malaysia
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Kota Kinabalu, Sabah, Malaysia
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Rotterdam, , Netherlands
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Cebu City, , Philippines
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Manila, , Philippines
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Quezon City, , Philippines
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Elblag, , Poland
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Gdansk, , Poland
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Jelenia Góra, , Poland
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Poznan, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Bucharest, , Romania
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Sibiu, , Romania
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Kamenitz, , Serbia
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Niš, , Serbia
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Singapore, , Singapore
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Singapore, , Singapore
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Bardejov, , Slovakia
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Bratislava, , Slovakia
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Nitra, , Slovakia
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Groenkloof, Gauteng, South Africa
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Johannesburg, Gauteng, South Africa
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Kraaifontein, Western Cape, South Africa
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Johannesburg, , South Africa
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Port Elizabeth, , South Africa
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Goyang-si, Gyeonggi-do, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Gothenburg, , Sweden
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Linköping, , Sweden
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Lund, , Sweden
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Uppsala, , Sweden
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Vaxjo, , Sweden
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Västerås, , Sweden
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Putzu City, Chiayi, Taiwan
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Keelung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
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Belfast, , United Kingdom
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Bristol, , United Kingdom
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Cardiff, , United Kingdom
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Guildford, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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Maidstone, , United Kingdom
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Manchester, , United Kingdom
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Oxford, , United Kingdom
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Sutton, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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References
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Price T, Kim TW, Li J, Cascinu S, Ruff P, Suresh AS, Thomas A, Tjulandin S, Guan X, Peeters M. Final results and outcomes by prior bevacizumab exposure, skin toxicity, and hypomagnesaemia from ASPECCT: randomized phase 3 non-inferiority study of panitumumab versus cetuximab in chemorefractory wild-type KRAS exon 2 metastatic colorectal cancer. Eur J Cancer. 2016 Nov;68:51-59. doi: 10.1016/j.ejca.2016.08.010. Epub 2016 Oct 5.
Price TJ, Peeters M, Kim TW, Li J, Cascinu S, Ruff P, Suresh AS, Thomas A, Tjulandin S, Zhang K, Murugappan S, Sidhu R. Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (ASPECCT): a randomised, multicentre, open-label, non-inferiority phase 3 study. Lancet Oncol. 2014 May;15(6):569-79. doi: 10.1016/S1470-2045(14)70118-4. Epub 2014 Apr 14.
Kim TW, Peeters M, Thomas A, Gibbs P, Hool K, Zhang J, Ang AL, Bach BA, Price T. Impact of Emergent Circulating Tumor DNA RAS Mutation in Panitumumab-Treated Chemoresistant Metastatic Colorectal Cancer. Clin Cancer Res. 2018 Nov 15;24(22):5602-5609. doi: 10.1158/1078-0432.CCR-17-3377. Epub 2018 Jun 13.
Peeters M, Price T, Boedigheimer M, Kim TW, Ruff P, Gibbs P, Thomas A, Demonty G, Hool K, Ang A. Evaluation of Emergent Mutations in Circulating Cell-Free DNA and Clinical Outcomes in Patients with Metastatic Colorectal Cancer Treated with Panitumumab in the ASPECCT Study. Clin Cancer Res. 2019 Feb 15;25(4):1216-1225. doi: 10.1158/1078-0432.CCR-18-2072. Epub 2018 Nov 28.
Price T, Ang A, Boedigheimer M, Kim TW, Li J, Cascinu S, Ruff P, Satya Suresh A, Thomas A, Tjulandin S, Peeters M. Frequency of S492R mutations in the epidermal growth factor receptor: analysis of plasma DNA from patients with metastatic colorectal cancer treated with panitumumab or cetuximab monotherapy. Cancer Biol Ther. 2020 Oct 2;21(10):891-898. doi: 10.1080/15384047.2020.1798695. Epub 2020 Oct 7.
Taniguchi H, Yamanaka T, Sakai D, Muro K, Yamazaki K, Nakata S, Kimura H, Ruff P, Kim TW, Peeters M, Price T. Efficacy of Panitumumab and Cetuximab in Patients with Colorectal Cancer Previously Treated with Bevacizumab; a Combined Analysis of Individual Patient Data from ASPECCT and WJOG6510G. Cancers (Basel). 2020 Jun 28;12(7):1715. doi: 10.3390/cancers12071715.
Graham CN, Maglinte GA, Schwartzberg LS, Price TJ, Knox HN, Hechmati G, Hjelmgren J, Barber B, Fakih MG. Economic Analysis of Panitumumab Compared With Cetuximab in Patients With Wild-type KRAS Metastatic Colorectal Cancer That Progressed After Standard Chemotherapy. Clin Ther. 2016 Jun;38(6):1376-1391. doi: 10.1016/j.clinthera.2016.03.023. Epub 2016 Apr 13.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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ASPECCT
Identifier Type: -
Identifier Source: secondary_id
2009-010715-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20080763
Identifier Type: -
Identifier Source: org_study_id
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