ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Subjects With KRAS Wild-Type Metastatic Colorectal Cancer

Condition(s) targeted: Metastatic Colorectal Cancer

Intervention: Cetuximab (Erbitux) (Drug); Panitumumab (Vectibix) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Overall contact:
Amgen Call Center, Phone: 866-572-6436

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 subjects with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To compare the effect of panitumumab versus cetuximab on overall survival for chemorefractory mCRC among subjects with wild-type KRAS tumors.

Secondary outcome:

To compare safety of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.

To compare patient reported outcomes of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.

To compare progression-free survival of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.

To compare objective response rate of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.

To compare time to response of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.

To compare time to treatment failure of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.

To compare duration of response of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Amgen Call Center, Phone: 866-572-6436

Research Site, Edegem 2650, Belgium; Recruiting

Research Site, Sofia 1784, Bulgaria; Completed

Research Site, Sofia 1527, Bulgaria; Recruiting

Research Site, Beijing 100021, China; Recruiting

Research Site, Beijing 100071, China; Recruiting

Research Site, Beijing 100142, China; Recruiting

Research Site, Shanghai 200032, China; Recruiting

Research Site, Shanghai 200080, China; Recruiting

Research Site, Tianjin 300060, China; Recruiting

Research Site, Horovice 268 31, Czech Republic; Recruiting

Research Site, Nova Ves pod Plesi 262 04, Czech Republic; Recruiting

Research Site, Olomouc 775 20, Czech Republic; Recruiting

Research Site, Praha 10 100 34, Czech Republic; Recruiting

Research Site, Pribram V-Zdabor 261 01, Czech Republic; Completed

Research Site, Znojmo 669 02, Czech Republic; Recruiting

Research Site, Besançon Cedex 25030, France; Recruiting

Research Site, Montbéliard 25200, France; Recruiting

Research Site, Saint Brieuc 22015, France; Recruiting

Research Site, Saint Herblain 44800, France; Recruiting

Research Site, Villejuif cedex 94805, France; Recruiting

Research Site, Hong Kong, Hong Kong; Recruiting

Research Site, Sha Tin 0000, Hong Kong; Recruiting

Research Site, Tuen Mun, Hong Kong; Recruiting

Research Site, Beer Sheva 64239, Israel; Recruiting

Research Site, Jerusalem 91031, Israel; Completed

Research Site, Kfar Saba 44281, Israel; Recruiting

Research Site, Ramat Gan 52621, Israel; Completed

Research Site, Rehovot 76100, Israel; Recruiting

Research Site, Ancona 60131, Italy; Completed

Research Site, Cesena 47023, Italy; Recruiting

Research Site, Cremona 26100, Italy; Recruiting

Research Site, Faenza 48018, Italy; Recruiting

Research Site, Genova 16132, Italy; Recruiting

Research Site, Lugo 48022, Italy; Recruiting

Research Site, Meldola FC 47014, Italy; Recruiting

Research Site, Ravenna 48100, Italy; Recruiting

Research Site, Rimini 47900, Italy; Recruiting

Research Site, Torino 10126, Italy; Recruiting

Research Site, Goyang-si, Gyeonggi-do 410-769, Korea, Republic of; Recruiting

Research Site, Seoul 138-736, Korea, Republic of; Recruiting

Research Site, Seoul 136-705, Korea, Republic of; Recruiting

Research Site, Seoul 120-752, Korea, Republic of; Recruiting

Research Site, Seoul 135-710, Korea, Republic of; Recruiting

Research Site, Seoul 110-744, Korea, Republic of; Recruiting

Research Site, Daugavpils 5417, Latvia; Recruiting

Research Site, Riga 1079, Latvia; Recruiting

Research Site, Riga 1002, Latvia; Recruiting

Research Site, Kaunas 50009, Lithuania; Recruiting

Research Site, Vilnius 08660, Lithuania; Recruiting

Research Site, Rotterdam 3000 CA, Netherlands; Completed

Research Site, Lima 34, Peru; Recruiting

Research Site, Lima Lima 27, Peru; Recruiting

Research Site, Lima 13, Peru; Recruiting

Research Site, Cebu City 6000, Philippines; Recruiting

Research Site, Manila 1000, Philippines; Recruiting

Research Site, Quezon City 1102, Philippines; Recruiting

Research Site, Elblag 82-300, Poland; Recruiting

Research Site, Gdansk 80-219, Poland; Recruiting

Research Site, Jelenia Gora 58-506, Poland; Recruiting

Research Site, Poznan 61-485, Poland; Recruiting

Research Site, Szczecin 71-730, Poland; Recruiting

Research Site, Warszawa 02-781, Poland; Recruiting

Research Site, Warszawa 02-507, Poland; Recruiting

Research Site, Warszawa 02-097, Poland; Recruiting

Research Site, Bucharest 022328, Romania; Completed

Research Site, Sibiu 550245, Romania; Completed

Research Site, Moscow 115478, Russian Federation; Recruiting

Research Site, Moscow 117997, Russian Federation; Recruiting

Research Site, Saint-Petersburg 198255, Russian Federation; Recruiting

Research Site, St Petersburg 197758, Russian Federation; Recruiting

Research Site, Nis 18000, Serbia; Completed

Research Site, Sremska Kamenica 21204, Serbia; Recruiting

Research Site, Singapore 308433, Singapore; Recruiting

Research Site, Singapore 119074, Singapore; Recruiting

Research Site, Bardejov 085 01, Slovakia; Recruiting

Research Site, Bratislava 831 01, Slovakia; Recruiting

Research Site, Nitra 950 01, Slovakia; Recruiting

Research Site, Johannesburg 2193, South Africa; Recruiting

Research Site, Port Elizabeth 6045, South Africa; Recruiting

Research Site, Göteborg 416 85, Sweden; Recruiting

Research Site, Linköping 581 85, Sweden; Recruiting

Research Site, Lund 221 85, Sweden; Recruiting

Research Site, Uppsala 751 85, Sweden; Recruiting

Research Site, Västerås 721 89, Sweden; Recruiting

Research Site, Växjö 351 85, Sweden; Recruiting

Research Site, Keelung 20401, Taiwan; Recruiting

Research Site, Tainan 70403, Taiwan; Recruiting

Research Site, Taipei 11031, Taiwan; Recruiting

Research Site, Belfast BT9 7AB, United Kingdom; Recruiting

Research Site, Bristol BS2 8ED, United Kingdom; Recruiting

Research Site, Cardiff CF14 2TL, United Kingdom; Recruiting

Research Site, Guildford GU2 7XX, United Kingdom; Recruiting

Research Site, Leicester LE1 5WW, United Kingdom; Recruiting

Research Site, London SW17 0QT, United Kingdom; Recruiting

Research Site, Maidstone ME16 9QQ, United Kingdom; Completed

Research Site, Manchester M20 4BX, United Kingdom; Recruiting

Research Site, Oxford OX3 7LJ, United Kingdom; Completed

Research Site, Sutton SM2 5PT, United Kingdom; Recruiting

Research Site, Wolverhampton WV10 0QP, United Kingdom; Recruiting

Research Site, Edmonton, Alberta T6G 1Z2, Canada; Recruiting

Research Site, Hyderabad, Andhra Pra 500 024, India; Recruiting

Research Site, Hyderabad, Andhra Pra 500 034, India; Recruiting

Research Site, Stockton, California 95204, United States; Completed

Research Site, Putzu City, Chiayi 61363, Taiwan; Recruiting

Research Site, Boynton Beach, Florida 33426, United States; Recruiting

Research Site, Johannesburg, Gauteng 2199, South Africa; Recruiting

Research Site, Pretoria (Groenkloof), Gauteng 0181, South Africa; Recruiting

Research Site, Changsha, Hunan 410013, China; Recruiting

Research Site, Nanjing, Jiangsu 210002, China; Recruiting

Research Site, Wichita, Kansas 67214, United States; Recruiting

Research Site, Kota Bharu, Kelantan 16150, Malaysia; Recruiting

Research Site, Kochi, Kerala 682 304, India; Recruiting

Research Site, Ahmednagar, Maharashtr 413 736, India; Recruiting

Research Site, Nagpur, Maharashtr 440 012, India; Recruiting

Research Site, Nashik, Maharashtr 422 004, India; Recruiting

Research Site, Nashik, Maharashtr 422 005, India; Recruiting

Research Site, Pune, Maharashtr 411 004, India; Completed

Research Site, Pune, Maharashtr 411 004, India; Recruiting

Research Site, Liverpool, New South Wales 2170, Australia; Recruiting

Research Site, St Leonards, New South Wales 2065, Australia; Recruiting

Research Site, Wahroonga, New South Wales 2076, Australia; Recruiting

Research Site, Wollongong, New South Wales 2500, Australia; Recruiting

Research Site, Halifax, Nova Scotia B3H 2Y9, Canada; Recruiting

Research Site, Jaipur, Rajasthan 302 013, India; Recruiting

Research Site, Kota Kinabalu, Sabah 88997, Malaysia; Recruiting

Research Site, Chongqing, Sichuan 400038, China; Recruiting

Research Site, Woodville South, South Australia 5011, Australia; Recruiting

Research Site, Chennai, Tamil Nadu 600 018, India; Recruiting

Research Site, Gueishan Township, Taoyuan 33305, Taiwan; Recruiting

Research Site, Temple, Texas 76508, United States; Recruiting

Research Site, Ogden, Utah 84403, United States; Completed

Research Site, Ballarat, Victoria 3350, Australia; Recruiting

Research Site, Box Hill, Victoria 3128, Australia; Recruiting

Research Site, Epping, Victoria 3076, Australia; Recruiting

Research Site, Footscray, Victoria 3011, Australia; Recruiting

Research Site, Heidelberg, Victoria 3084, Australia; Recruiting

Research Site, Parkville, Victoria 3050, Australia; Recruiting

Research Site, Kolkata, West Benga 700 016, India; Recruiting

Research Site, Kraaifontein, Western Ca 7570, South Africa; Recruiting

Research Site, Kuala Lumpur, Wilayah Pe 50703, Malaysia; Recruiting

Research Site, Kuala Lumpur, Wilayah Pe 56000, Malaysia; Recruiting

Research Site, Hangzhou, Zhejiang 310016, China; Recruiting

AmgenTrials clinical trials website

Starting date: February 2010
Last updated: June 14, 2012