ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects With Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer
3 other identifiers
interventional
1,010
28 countries
146
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2010
Longer than P75 for phase_3
146 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2009
CompletedFirst Posted
Study publicly available on registry
October 26, 2009
CompletedStudy Start
First participant enrolled
February 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2013
CompletedResults Posted
Study results publicly available
March 24, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2017
CompletedSeptember 21, 2022
September 1, 2022
3 years
October 22, 2009
February 3, 2014
September 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival is the time from the date of randomization until the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date.
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Secondary Outcomes (11)
Progression-free Survival
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Objective Response
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Duration of Response
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Time to Response
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Time to Treatment Failure
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
- +6 more secondary outcomes
Study Arms (2)
Cetuximab
ACTIVE COMPARATORCetuximab 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.
Panitumumab
EXPERIMENTALPanitumumab 6 mg/kg IV every 14 days. Participants were treated until disease progression, intolerability, withdrawal of consent, or death.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (152)
Research Site
Stockton, California, 95204, United States
Research Site
Boynton Beach, Florida, 33426, United States
Research Site
Wichita, Kansas, 67214, United States
Research Site
Temple, Texas, 76508, United States
Research Site
Ogden, Utah, 84403, United States
Research Site
Liverpool, New South Wales, 2170, Australia
Research Site
St Leonards, New South Wales, 2065, Australia
Research Site
Wahroonga, New South Wales, 2076, Australia
Research Site
Wollongong, New South Wales, 2500, Australia
Research Site
Woodville South, South Australia, 5011, Australia
Research Site
Ballarat, Victoria, 3350, Australia
Research Site
Box Hill, Victoria, 3128, Australia
Research Site
Epping, Victoria, 3076, Australia
Research Site
Footscray, Victoria, 3011, Australia
Research Site
Heidelberg, Victoria, 3084, Australia
Research Site
Parkville, Victoria, 3050, Australia
Research Site
Edegem, 2650, Belgium
Research Site
Sofia, 1527, Bulgaria
Research Site
Sofia, 1784, Bulgaria
Research Site
Edmonton, Alberta, T6G 1Z2, Canada
Research Site
Halifax, Nova Scotia, B3H 2Y9, Canada
Research Site
Guangzhou, Guangdong, 510060, China
Research Site
Guangzhou, Guangdong, 510180, China
Research Site
Guangzhou, Guangdong, 510280, China
Research Site
Guangzhou, Guangdong, 515515, China
Research Site
Harbin, Heilongjiang, 150040, China
Research Site
Changsha, Hunan, 410013, China
Research Site
Nanjing, Jiangsu, 210002, China
Research Site
Changchun, Jilin, 130012, China
Research Site
Xi'an, Shaanxi, 710061, China
Research Site
Shanghai, Shanghai Municipality, 200092, China
Research Site
Chengdu, Sichuan, 610041, China
Research Site
Chongqing, Sichuan, 400038, China
Research Site
Hangzhou, Zhejiang, 310009, China
Research Site
Hangzhou, Zhejiang, 310016, China
Research Site
Beijing, 100021, China
Research Site
Beijing, 100071, China
Research Site
Beijing, 100142, China
Research Site
Shanghai, 200003, China
Research Site
Shanghai, 200032, China
Research Site
Shanghai, 200080, China
Research Site
Tianjin, 300060, China
Research Site
Hořovice, 268 31, Czechia
Research Site
Nová Ves pod Pleší, 262 04, Czechia
Research Site
Olomouc, 775 20, Czechia
Research Site
Prague, 100 34, Czechia
Research Site
Příbram, 261 01, Czechia
Research Site
Znojmo, 669 02, Czechia
Research Site
Besançon, 25030, France
Research Site
Montbéliard, 25200, France
Research Site
Saint-Brieuc, 22015, France
Research Site
Saint-Herblain, 44800, France
Research Site
Villejuif, 94805, France
Research Site
Kowloon, Hong Kong
Research Site
New Territories, Hong Kong
Research Site
Hyderabad, Andhra Pradesh, 500 024, India
Research Site
Hyderabad, Andhra Pradesh, 500 034, India
Research Site
Kochi, Kerala, 682 304, India
Research Site
Ahilyanagar, Maharashtra, 413 736, India
Research Site
Nagpur, Maharashtra, 440 012, India
Research Site
Nashik, Maharashtra, 422 004, India
Research Site
Nashik, Maharashtra, 422 005, India
Research Site
Pune, Maharashtra, 411 004, India
Research Site
Jaipur, Rajasthan, 302 013, India
Research Site
Chennai, Tamil Nadu, 600 018, India
Research Site
Kolkata, West Bengal, 700 016, India
Research Site
Beersheba, 64239, Israel
Research Site
Jerusalem, 91031, Israel
Research Site
Kfar Saba, 44281, Israel
Research Site
Ramat Gan, 52621, Israel
Research Site
Rehovot, 76100, Israel
Research Site
Ancona, 60131, Italy
Research Site
Cesena, 47023, Italy
Research Site
Cremona, 26100, Italy
Research Site
Faenza RA, 48018, Italy
Research Site
Genova, 16132, Italy
Research Site
Lugo, 48022, Italy
Research Site
Meldola FC, 47014, Italy
Research Site
Ravenna, 48100, Italy
Research Site
Rimini, 47900, Italy
Research Site
Torino, 10126, Italy
Research Site
Daugavpils, 5417, Latvia
Research Site
Riga, 1002, Latvia
Research Site
Riga, 1079, Latvia
Research Site
Kaunas, 50009, Lithuania
Research Site
Vilnius, 08660, Lithuania
Research Site
Kota Bharu, Kelantan, 16150, Malaysia
Research Site
Kuala Lumpur, Kuala Lumpur, 56000, Malaysia
Research Site
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
Research Site
Kota Kinabalu, Sabah, 88996, Malaysia
Research Site
Rotterdam, 3000 CA, Netherlands
Research Site
Lima, 13, Peru
Research Site
Lima, 34, Peru
Research Site
Lima, Lima 27, Peru
Research Site
Cebu City, 6000, Philippines
Research Site
Manila, 1000, Philippines
Research Site
Quezon City, 1102, Philippines
Research Site
Elblag, 82-300, Poland
Research Site
Gdansk, 80-219, Poland
Research Site
Jelenia Góra, 58-506, Poland
Research Site
Poznan, 61-485, Poland
Research Site
Szczecin, 71-730, Poland
Research Site
Warsaw, 02-097, Poland
Research Site
Warsaw, 02-507, Poland
Research Site
Warsaw, 02-781, Poland
Research Site
Bucharest, 022328, Romania
Research Site
Sibiu, 550245, Romania
Research Site
Moscow, 115478, Russia
Research Site
Moscow, 117997, Russia
Research Site
Saint Petersburg, 197022, Russia
Research Site
Saint Petersburg, 197758, Russia
Research Site
Saint Petersburg, 198255, Russia
Research Site
Kamenitz, 21204, Serbia
Research Site
Niš, 18000, Serbia
Research Site
Singapore, 119228, Singapore
Research Site
Singapore, 308433, Singapore
Research Site
Bardejov, 085 01, Slovakia
Research Site
Bratislava, 831 01, Slovakia
Research Site
Nitra, 950 01, Slovakia
Research Site
Groenkloof, Gauteng, 0181, South Africa
Research Site
Johannesburg, Gauteng, 2199, South Africa
Research Site
Kraaifontein, Western Cape, 7570, South Africa
Research Site
Johannesburg, 2193, South Africa
Research Site
Port Elizabeth, 6045, South Africa
Research Site
Goyang-si, Gyeonggi-do, 410-769, South Korea
Research Site
Seoul, 110-744, South Korea
Research Site
Seoul, 120-752, South Korea
Research Site
Seoul, 135-710, South Korea
Research Site
Seoul, 136-705, South Korea
Research Site
Seoul, 138-736, South Korea
Research Site
Gothenburg, 416 85, Sweden
Research Site
Linköping, 581 85, Sweden
Research Site
Lund, 221 85, Sweden
Research Site
Uppsala, 751 85, Sweden
Research Site
Vaxjo, 351 85, Sweden
Research Site
Västerås, 721 89, Sweden
Research Site
Putzu City, Chiayi, 61363, Taiwan
Research Site
Keelung, 20401, Taiwan
Research Site
Tainan, 70403, Taiwan
Research Site
Taipei, 11031, Taiwan
Research Site
Taoyuan District, 33305, Taiwan
Research Site
Belfast, BT9 7AB, United Kingdom
Research Site
Bristol, BS2 8ED, United Kingdom
Research Site
Cardiff, CF14 2TL, United Kingdom
Research Site
Guildford, GU2 7XX, United Kingdom
Research Site
Leicester, LE1 5WW, United Kingdom
Research Site
London, SW17 0QT, United Kingdom
Research Site
Maidstone, ME16 9QQ, United Kingdom
Research Site
Manchester, M20 4BX, United Kingdom
Research Site
Oxford, OX3 7LJ, United Kingdom
Research Site
Sutton, SM2 5PT, United Kingdom
Research Site
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (7)
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.
PMID: 27716478BACKGROUNDPrice 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.
PMID: 24739896BACKGROUNDKim 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.
PMID: 29898991BACKGROUNDPeeters 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.
PMID: 30487126BACKGROUNDPrice 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.
PMID: 33026965BACKGROUNDTaniguchi 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.
PMID: 32605298DERIVEDGraham 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.
PMID: 27085587DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2009
First Posted
October 26, 2009
Study Start
February 2, 2010
Primary Completion
February 5, 2013
Study Completion
March 7, 2017
Last Updated
September 21, 2022
Results First Posted
March 24, 2014
Record last verified: 2022-09