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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01001377




Registration number
NCT01001377
Ethics application status
Date submitted
22/10/2009
Date registered
26/10/2009
Date last updated
26/12/2018

Titles & IDs
Public title
ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
Scientific 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
Secondary ID [1] 0 0
ASPECCT
Secondary ID [2] 0 0
20080763
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cetuximab
Treatment: Drugs - Panitumumab

Active Comparator: 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.

Experimental: Panitumumab - Panitumumab 6 mg/kg IV every 14 days. Participants were treated until disease progression, intolerability, withdrawal of consent, or death.


Treatment: Drugs: Cetuximab
Administered by intravenous infusion

Treatment: Drugs: Panitumumab
Administered by intravenous infusion

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Secondary outcome [1] 0 0
Progression-free Survival - Progression free survival (PFS) is the time from the date of randomization to the date of disease progression per the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Participants alive and not meeting criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.
Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study based on all target lesions recorded since the treatment started (the sum must also demonstrate an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or any new lesions.
Timepoint [1] 0 0
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Secondary outcome [2] 0 0
Objective Response - Objective response is either a complete response (CR) or partial response (PR) per RECIST version 1.1. All participants that did not meet the criteria for an objective response by the analysis cut-off date were considered non-responders. CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, and disappearance of all non-target lesions, and no new lesions. PR: Disappearance of all target lesions, persistence of one or more non-target lesions not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of diameters of target lesions with no unequivocal progression of existing non-target lesions and no new lesions.
Timepoint [2] 0 0
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Secondary outcome [3] 0 0
Duration of Response - Duration of response (DOR), calculated only for those participants with an objective response, is the time from first objective response to disease progression per the RECIST v1.1 or death. Participants not meeting criteria for progression or who died by the analysis data cutoff date were censored at their last evaluable disease assessment date.
Timepoint [3] 0 0
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Secondary outcome [4] 0 0
Time to Response - Time to response (TTR), calculated for those participants with an objective response, is defined as the time from the randomization date to the date of first objective response.
Timepoint [4] 0 0
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Secondary outcome [5] 0 0
Time to Treatment Failure - Time to treatment failure (TTF) is the time from randomization date to date that the decision was made to end the treatment period for any reason; participants who remained in the treatment period at the time of analysis were censored at the date of the last on-study assessment.
Timepoint [5] 0 0
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Secondary outcome [6] 0 0
Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score - The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The health state index measures the following 5 health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension contains 3 levels of response to reflect degree of problems participants have experienced: no problem (1), some problem (2) and extreme problems (3). The health states for each respondent are converted into a single index number using a specified set of weights. Resulting scores can range from 1.0 and -0.594. A higher score indicates a more preferred health status with 1.0 representing perfect health and 0 representing death. Negative scores are possible and represent health states regarded as less preferable than death (0). Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and participants a random effect.
Timepoint [6] 0 0
From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Secondary outcome [7] 0 0
Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS) - The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The VAS asks respondents to rate their present health status on a 0 - 100 scale, with 0 labeled as "Worst imaginable health state" and 100 labeled as "Best imaginable health state." The VAS score is determined by observing the point at which the participant's hand drawn line intersects the scale.
Timepoint [7] 0 0
From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Secondary outcome [8] 0 0
Change From Baseline in National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index (NCCN FCSI ) Symptoms Score - The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).
Timepoint [8] 0 0
From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Secondary outcome [9] 0 0
Change From Baseline in NCCN FCSI Physical Well-being Scale Score - The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).
Timepoint [9] 0 0
From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Secondary outcome [10] 0 0
Change From Baseline in NCCN FCSI Functional Well-being Scale Score - The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).
Timepoint [10] 0 0
From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Secondary outcome [11] 0 0
Number of Participants With Adverse Events (AEs) - Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs are those the investigator considered as a reasonable possibility to have been caused by study drug.
Timepoint [11] 0 0
From the day of the first dose of study therapy through 30 days since the last dose. Maximum time on study treatment was 130 weeks.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Liverpool
Recruitment hospital [2] 0 0
Research Site - St Leonards
Recruitment hospital [3] 0 0
Research Site - Wahroonga
Recruitment hospital [4] 0 0
Research Site - Wollongong
Recruitment hospital [5] 0 0
Research Site - Woodville South
Recruitment hospital [6] 0 0
Research Site - Ballarat
Recruitment hospital [7] 0 0
Research Site - Box Hill
Recruitment hospital [8] 0 0
Research Site - Epping
Recruitment hospital [9] 0 0
Research Site - Footscray
Recruitment hospital [10] 0 0
Research Site - Heidelberg
Recruitment hospital [11] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2076 - Wahroonga
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment postcode(s) [6] 0 0
3350 - Ballarat
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3076 - Epping
Recruitment postcode(s) [9] 0 0
3011 - Footscray
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment postcode(s) [11] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Florida
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United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Utah
Country [6] 0 0
Belgium
State/province [6] 0 0
Edegem
Country [7] 0 0
Bulgaria
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Sofia
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Canada
State/province [8] 0 0
Alberta
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Canada
State/province [9] 0 0
Nova Scotia
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China
State/province [10] 0 0
Guangdong
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China
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Heilongjiang
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China
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Hunan
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China
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Jiangsu
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China
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Jilin
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China
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Shaanxi
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China
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Shanghai
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China
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Sichuan
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China
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Zhejiang
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China
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Beijing
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China
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Tianjin
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Czechia
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Horovice
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Czechia
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Nova Ves pod Plesi
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Czechia
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Olomouc
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Czechia
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Praha 10
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Czechia
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Pribram
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Czechia
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Znojmo
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France
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Besançon Cedex
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France
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Montbéliard
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France
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Saint Brieuc
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France
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Saint Herblain
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France
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Villejuif cedex
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Hong Kong
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Kowloon
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Hong Kong
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New Territories
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India
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Andhra Pradesh
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India
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Kerala
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India
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Maharashtra
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India
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Rajasthan
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India
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Tamil Nadu
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West Bengal
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Israel
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Beer Sheva
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Ramat Gan
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Israel
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Rehovot
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Italy
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Ancona
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Italy
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Cesena
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Italy
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Cremona
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Italy
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Faenza RA
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Genova
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Italy
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Lugo
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Italy
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Meldola FC
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Italy
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Ravenna
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Italy
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Rimini
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Italy
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Torino
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Korea, Republic of
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Goyang-si, Gyeonggi-do
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Korea, Republic of
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Seoul
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Latvia
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Daugavpils
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Latvia
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Riga
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Malaysia
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Kelantan
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Malaysia
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Sabah
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Malaysia
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Wilayah Persekutuan
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Netherlands
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Rotterdam
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Peru
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Lima
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Philippines
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Cebu City
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Philippines
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Manila
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Philippines
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Quezon City
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Poland
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Elblag
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Poland
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Gdansk
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Poland
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Jelenia Gora
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Poland
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Poznan
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Poland
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Szczecin
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Poland
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Warszawa
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Romania
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Bucharest
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Romania
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Sibiu
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Russian Federation
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Moscow
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Russian Federation
State/province [78] 0 0
Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Serbia
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Nis
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Serbia
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Sremska Kamenica
Country [82] 0 0
Singapore
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Singapore
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Slovakia
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Bardejov
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Slovakia
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Bratislava
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Slovakia
State/province [85] 0 0
Nitra
Country [86] 0 0
South Africa
State/province [86] 0 0
Gauteng
Country [87] 0 0
South Africa
State/province [87] 0 0
Western Cape
Country [88] 0 0
South Africa
State/province [88] 0 0
Johannesburg
Country [89] 0 0
South Africa
State/province [89] 0 0
Port Elizabeth
Country [90] 0 0
Sweden
State/province [90] 0 0
Göteborg
Country [91] 0 0
Sweden
State/province [91] 0 0
Linköping
Country [92] 0 0
Sweden
State/province [92] 0 0
Lund
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Sweden
State/province [93] 0 0
Uppsala
Country [94] 0 0
Sweden
State/province [94] 0 0
Västerås
Country [95] 0 0
Sweden
State/province [95] 0 0
Växjö
Country [96] 0 0
Taiwan
State/province [96] 0 0
Chiayi
Country [97] 0 0
Taiwan
State/province [97] 0 0
Keelung
Country [98] 0 0
Taiwan
State/province [98] 0 0
Tainan
Country [99] 0 0
Taiwan
State/province [99] 0 0
Taipei
Country [100] 0 0
Taiwan
State/province [100] 0 0
Taoyuan
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Belfast
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Bristol
Country [103] 0 0
United Kingdom
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Cardiff
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United Kingdom
State/province [104] 0 0
Guildford
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United Kingdom
State/province [105] 0 0
Leicester
Country [106] 0 0
United Kingdom
State/province [106] 0 0
London
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Maidstone
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Manchester
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Oxford
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Sutton
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT01001377
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications