Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer
A Phase 3, Multicenter, Randomized, Open-label Trial to Evaluate the Survival Benefit of Panitumumab and Best Supportive Care, Compared to Best Supportive Care Alone, in Subjects With Chemorefractory Wild-type KRAS Metastatic Colorectal Cancer
2 other identifiers
interventional
377
16 countries
78
Brief Summary
The purpose of this study is to evaluate the benefit of panitumumab in addition to best supportive care compared to best supportive care alone in patients with chemorefractory wild-type KRAS (Kirsten rat sarcoma viral oncogene homolog) metastatic colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2011
Longer than P75 for phase_3
78 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
March 31, 2011
CompletedFirst Posted
Study publicly available on registry
August 9, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedResults Posted
Study results publicly available
April 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedMarch 15, 2017
February 1, 2017
2.6 years
March 31, 2011
March 2, 2016
February 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.
From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).
Secondary Outcomes (7)
Progression-free Survival
From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).
Overall Survival in Participants With Wild-type RAS
From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).
Progression Free Survival (PFS) in Participants With Wild-type RAS
From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).
Objective Response Rate
Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).
Objective Response Rate in Participants With Wild-type RAS
Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).
- +2 more secondary outcomes
Study Arms (2)
Panitumumab + BSC
EXPERIMENTALParticipants received panitumumab administered intravenously 6 mg/kg every 14 days plus BSC until disease progression, withdrawal of consent, death, or intolerance of study drug.
BSC Alone
OTHERParticipants received best supportive care until disease progression, withdrawal of consent, or death.
Interventions
BSC was defined as the best palliative care available as judged appropriate by the investigator and according to institutional guidelines and could include antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy as clinically indicated.
Eligibility Criteria
You may qualify if:
- Diagnosis of metastatic colorectal cancer (CRC)
- Wild-type (without mutation in codons 12 and 13) KRAS gene in tumor tissue confirmed by a central laboratory
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- At least 1 measurable or non-measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
- Treatment failure (defined as failure due to either disease progression \[clinical or radiological\] or toxicity \[treatment intolerance\]) of a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease. Oxaliplatin and irinotecan may have been administered sequentially or in combination.
- Disease relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease
- Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of CRC
- Man or woman at least 18 years of age
- Adequate hematologic, renal, hepatic and metabolic function
- Negative pregnancy test within 72 hours before randomization (for women of childbearing potential only)
- Subject or subject's legally acceptable representative has provided informed consent.
- Other protocol-specified criteria may apply
You may not qualify if:
- Symptomatic brain metastases requiring treatment
- History of another primary cancer within 5 years of randomization
- 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) within 21 days before randomization
- Radiotherapy within 14 days before randomization.
- Other protocol-specified criteria may apply
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (78)
Research Site
Curitiba, Paraná, 80420-090, Brazil
Research Site
Natal, Rio Grande do Norte, 59075-740, Brazil
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Ijuí, Rio Grande do Sul, 98700-000, Brazil
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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Québec, Quebec, G1R 2J6, Canada
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Québec, Quebec, G1S 4L8, Canada
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Trois-Rivières, Quebec, G8Z 3R9, Canada
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Temuco, Cautín, 4810469, Chile
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Viña del Mar, Región de Valparaíso, 2520612, Chile
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Fuzhou, Fujian, 350001, China
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Fuzhou, Fujian, 350025, China
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Shijiazhuang, Hebei, 050011, China
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Nanjing, Jiangsu, 210029, China
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Changchun, Jilin, 130021, China
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Shenyang, Liaoning, 110001, China
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Xi'an, Shaanxi, 710032, China
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Xi'an, Shaanxi, 710061, China
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Beijing, 100032, China
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Chongqing, 400037, China
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Chongqing, 400042, China
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Shanghai, 200233, China
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Osijek, 31000, Croatia
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Pula, 52100, Croatia
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Rijeka, 51000, Croatia
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Split, 21000, Croatia
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Zagreb, 10000, Croatia
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Tallinn, 13419, Estonia
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Tartu, 51014, Estonia
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Athens, 11522, Greece
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Chania, 73300, Greece
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Hyderabad, Andhra Pradesh, 500 024, India
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Visakhapatnam, Andhra Pradesh, 530 002, India
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Bangalore, Karnataka, 560 054, India
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Kochi, Kerala, 682 304, India
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Mumbai, Maharashtra, 400 012, India
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Nashik, Maharashtra, 422 004, India
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Nashik, Maharashtra, 422 005, India
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Pune, Maharashtra, 411 001, India
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Chennai, Tamil Nadu, 600 018, India
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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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Kuala Lumpur, Kuala Lumpur, 56000, Malaysia
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Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
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Kampung Baharu Nilai, Negeri Sembilan, 71800, Malaysia
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George Town, Pulau Pinang, 10400, Malaysia
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Mexico City, Mexico City, 06760, Mexico
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Mexico City, Mexico City, 14080, Mexico
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Cuernavaca, Morelos, 62290, Mexico
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Oaxaca City, Oaxaca, 68000, Mexico
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Davao City, Davao Region, 8000, Philippines
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Cebu City, 6000, Philippines
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Manila, 1000, Philippines
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Manila, 1008, Philippines
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Pasay, 1300, Philippines
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Bucharest, 022328, Romania
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Bucharest, 022338, Romania
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Cluj-Napoca, 400006, Romania
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Cluj-Napoca, 400015, Romania
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Cluj-Napoca, 400058, Romania
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Craiova, 200385, Romania
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Craiova, 200642, Romania
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Lasi, 700106, Romania
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Ploieşti, 100337, Romania
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Suceava, 720237, Romania
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Timișoara, 300167, Romania
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Belgrade, 11000, Serbia
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Kamenitz, 21204, Serbia
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Niš, 18000, Serbia
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Goyang-si, Gyeonggi-do, 410-769, South Korea
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Seoul, 120-752, South Korea
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Seoul, 135-710, South Korea
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Seoul, 138-736, South Korea
Related Publications (1)
Kim TW, Elme A, Kusic Z, Park JO, Udrea AA, Kim SY, Ahn JB, Valencia RV, Krishnan S, Bilic A, Manojlovic N, Dong J, Guan X, Lofton-Day C, Jung AS, Vrdoljak E. A phase 3 trial evaluating panitumumab plus best supportive care vs best supportive care in chemorefractory wild-type KRAS or RAS metastatic colorectal cancer. Br J Cancer. 2016 Nov 8;115(10):1206-1214. doi: 10.1038/bjc.2016.309. Epub 2016 Oct 13.
PMID: 27736842BACKGROUND
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
March 31, 2011
First Posted
August 9, 2011
Study Start
November 1, 2011
Primary Completion
June 1, 2014
Study Completion
November 1, 2016
Last Updated
March 15, 2017
Results First Posted
April 8, 2016
Record last verified: 2017-02