Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01001377
Registration number
NCT01001377
Ethics application status
Date submitted
22/10/2009
Date registered
26/10/2009
Date last updated
21/09/2022
Titles & IDs
Public title
ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
Query!
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
Query!
Secondary ID [1]
0
0
ASPECCT
Query!
Secondary ID [2]
0
0
20080763
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Bowel - Back passage (rectum) or large bowel (colon)
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Survival
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Query!
Secondary outcome [1]
0
0
Progression-free Survival
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Query!
Secondary outcome [2]
0
0
Objective Response
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Query!
Secondary outcome [3]
0
0
Duration of Response
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Query!
Secondary outcome [4]
0
0
Time to Response
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Query!
Secondary outcome [5]
0
0
Time to Treatment Failure
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Query!
Secondary outcome [6]
0
0
Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Query!
Secondary outcome [7]
0
0
Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS)
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Query!
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
Query!
Assessment method [8]
0
0
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).
Query!
Timepoint [8]
0
0
From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Query!
Secondary outcome [9]
0
0
Change From Baseline in NCCN FCSI Physical Well-being Scale Score
Query!
Assessment method [9]
0
0
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).
Query!
Timepoint [9]
0
0
From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Query!
Secondary outcome [10]
0
0
Change From Baseline in NCCN FCSI Functional Well-being Scale Score
Query!
Assessment method [10]
0
0
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).
Query!
Timepoint [10]
0
0
From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Query!
Secondary outcome [11]
0
0
Number of Participants With Adverse Events (AEs)
Query!
Assessment method [11]
0
0
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.
Query!
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.
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
2/02/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
7/03/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1010
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Query!
Recruitment hospital [1]
0
0
Research Site - Liverpool
Query!
Recruitment hospital [2]
0
0
Research Site - St Leonards
Query!
Recruitment hospital [3]
0
0
Research Site - Wahroonga
Query!
Recruitment hospital [4]
0
0
Research Site - Wollongong
Query!
Recruitment hospital [5]
0
0
Research Site - Woodville South
Query!
Recruitment hospital [6]
0
0
Research Site - Ballarat
Query!
Recruitment hospital [7]
0
0
Research Site - Box Hill
Query!
Recruitment hospital [8]
0
0
Research Site - Epping
Query!
Recruitment hospital [9]
0
0
Research Site - Footscray
Query!
Recruitment hospital [10]
0
0
Research Site - Heidelberg
Query!
Recruitment hospital [11]
0
0
Research Site - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [2]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [3]
0
0
2076 - Wahroonga
Query!
Recruitment postcode(s) [4]
0
0
2500 - Wollongong
Query!
Recruitment postcode(s) [5]
0
0
5011 - Woodville South
Query!
Recruitment postcode(s) [6]
0
0
3350 - Ballarat
Query!
Recruitment postcode(s) [7]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [8]
0
0
3076 - Epping
Query!
Recruitment postcode(s) [9]
0
0
3011 - Footscray
Query!
Recruitment postcode(s) [10]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [11]
0
0
3050 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Kansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Texas
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Utah
Query!
Country [6]
0
0
Belgium
Query!
State/province [6]
0
0
Edegem
Query!
Country [7]
0
0
Bulgaria
Query!
State/province [7]
0
0
Sofia
Query!
Country [8]
0
0
Canada
Query!
State/province [8]
0
0
Alberta
Query!
Country [9]
0
0
Canada
Query!
State/province [9]
0
0
Nova Scotia
Query!
Country [10]
0
0
China
Query!
State/province [10]
0
0
Guangdong
Query!
Country [11]
0
0
China
Query!
State/province [11]
0
0
Heilongjiang
Query!
Country [12]
0
0
China
Query!
State/province [12]
0
0
Hunan
Query!
Country [13]
0
0
China
Query!
State/province [13]
0
0
Jiangsu
Query!
Country [14]
0
0
China
Query!
State/province [14]
0
0
Jilin
Query!
Country [15]
0
0
China
Query!
State/province [15]
0
0
Shaanxi
Query!
Country [16]
0
0
China
Query!
State/province [16]
0
0
Shanghai
Query!
Country [17]
0
0
China
Query!
State/province [17]
0
0
Sichuan
Query!
Country [18]
0
0
China
Query!
State/province [18]
0
0
Zhejiang
Query!
Country [19]
0
0
China
Query!
State/province [19]
0
0
Beijing
Query!
Country [20]
0
0
China
Query!
State/province [20]
0
0
Tianjin
Query!
Country [21]
0
0
Czechia
Query!
State/province [21]
0
0
Horovice
Query!
Country [22]
0
0
Czechia
Query!
State/province [22]
0
0
Nova Ves pod Plesi
Query!
Country [23]
0
0
Czechia
Query!
State/province [23]
0
0
Olomouc
Query!
Country [24]
0
0
Czechia
Query!
State/province [24]
0
0
Praha 10
Query!
Country [25]
0
0
Czechia
Query!
State/province [25]
0
0
Pribram
Query!
Country [26]
0
0
Czechia
Query!
State/province [26]
0
0
Znojmo
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Besançon Cedex
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Montbéliard
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Saint Brieuc
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Saint Herblain
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Villejuif cedex
Query!
Country [32]
0
0
Hong Kong
Query!
State/province [32]
0
0
Kowloon
Query!
Country [33]
0
0
Hong Kong
Query!
State/province [33]
0
0
New Territories
Query!
Country [34]
0
0
India
Query!
State/province [34]
0
0
Andhra Pradesh
Query!
Country [35]
0
0
India
Query!
State/province [35]
0
0
Kerala
Query!
Country [36]
0
0
India
Query!
State/province [36]
0
0
Maharashtra
Query!
Country [37]
0
0
India
Query!
State/province [37]
0
0
Rajasthan
Query!
Country [38]
0
0
India
Query!
State/province [38]
0
0
Tamil Nadu
Query!
Country [39]
0
0
India
Query!
State/province [39]
0
0
West Bengal
Query!
Country [40]
0
0
Israel
Query!
State/province [40]
0
0
Beer Sheva
Query!
Country [41]
0
0
Israel
Query!
State/province [41]
0
0
Jerusalem
Query!
Country [42]
0
0
Israel
Query!
State/province [42]
0
0
Kfar Saba
Query!
Country [43]
0
0
Israel
Query!
State/province [43]
0
0
Ramat Gan
Query!
Country [44]
0
0
Israel
Query!
State/province [44]
0
0
Rehovot
Query!
Country [45]
0
0
Italy
Query!
State/province [45]
0
0
Ancona
Query!
Country [46]
0
0
Italy
Query!
State/province [46]
0
0
Cesena
Query!
Country [47]
0
0
Italy
Query!
State/province [47]
0
0
Cremona
Query!
Country [48]
0
0
Italy
Query!
State/province [48]
0
0
Faenza RA
Query!
Country [49]
0
0
Italy
Query!
State/province [49]
0
0
Genova
Query!
Country [50]
0
0
Italy
Query!
State/province [50]
0
0
Lugo
Query!
Country [51]
0
0
Italy
Query!
State/province [51]
0
0
Meldola FC
Query!
Country [52]
0
0
Italy
Query!
State/province [52]
0
0
Ravenna
Query!
Country [53]
0
0
Italy
Query!
State/province [53]
0
0
Rimini
Query!
Country [54]
0
0
Italy
Query!
State/province [54]
0
0
Torino
Query!
Country [55]
0
0
Korea, Republic of
Query!
State/province [55]
0
0
Goyang-si, Gyeonggi-do
Query!
Country [56]
0
0
Korea, Republic of
Query!
State/province [56]
0
0
Seoul
Query!
Country [57]
0
0
Latvia
Query!
State/province [57]
0
0
Daugavpils
Query!
Country [58]
0
0
Latvia
Query!
State/province [58]
0
0
Riga
Query!
Country [59]
0
0
Lithuania
Query!
State/province [59]
0
0
Kaunas
Query!
Country [60]
0
0
Lithuania
Query!
State/province [60]
0
0
Vilnius
Query!
Country [61]
0
0
Malaysia
Query!
State/province [61]
0
0
Kelantan
Query!
Country [62]
0
0
Malaysia
Query!
State/province [62]
0
0
Sabah
Query!
Country [63]
0
0
Malaysia
Query!
State/province [63]
0
0
Wilayah Persekutuan
Query!
Country [64]
0
0
Netherlands
Query!
State/province [64]
0
0
Rotterdam
Query!
Country [65]
0
0
Peru
Query!
State/province [65]
0
0
Lima
Query!
Country [66]
0
0
Philippines
Query!
State/province [66]
0
0
Cebu City
Query!
Country [67]
0
0
Philippines
Query!
State/province [67]
0
0
Manila
Query!
Country [68]
0
0
Philippines
Query!
State/province [68]
0
0
Quezon City
Query!
Country [69]
0
0
Poland
Query!
State/province [69]
0
0
Elblag
Query!
Country [70]
0
0
Poland
Query!
State/province [70]
0
0
Gdansk
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Jelenia Gora
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Poznan
Query!
Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Szczecin
Query!
Country [74]
0
0
Poland
Query!
State/province [74]
0
0
Warszawa
Query!
Country [75]
0
0
Romania
Query!
State/province [75]
0
0
Bucharest
Query!
Country [76]
0
0
Romania
Query!
State/province [76]
0
0
Sibiu
Query!
Country [77]
0
0
Russian Federation
Query!
State/province [77]
0
0
Moscow
Query!
Country [78]
0
0
Russian Federation
Query!
State/province [78]
0
0
Saint Petersburg
Query!
Country [79]
0
0
Russian Federation
Query!
State/province [79]
0
0
Saint-Petersburg
Query!
Country [80]
0
0
Serbia
Query!
State/province [80]
0
0
Nis
Query!
Country [81]
0
0
Serbia
Query!
State/province [81]
0
0
Sremska Kamenica
Query!
Country [82]
0
0
Singapore
Query!
State/province [82]
0
0
Singapore
Query!
Country [83]
0
0
Slovakia
Query!
State/province [83]
0
0
Bardejov
Query!
Country [84]
0
0
Slovakia
Query!
State/province [84]
0
0
Bratislava
Query!
Country [85]
0
0
Slovakia
Query!
State/province [85]
0
0
Nitra
Query!
Country [86]
0
0
South Africa
Query!
State/province [86]
0
0
Gauteng
Query!
Country [87]
0
0
South Africa
Query!
State/province [87]
0
0
Western Cape
Query!
Country [88]
0
0
South Africa
Query!
State/province [88]
0
0
Johannesburg
Query!
Country [89]
0
0
South Africa
Query!
State/province [89]
0
0
Port Elizabeth
Query!
Country [90]
0
0
Sweden
Query!
State/province [90]
0
0
Göteborg
Query!
Country [91]
0
0
Sweden
Query!
State/province [91]
0
0
Linköping
Query!
Country [92]
0
0
Sweden
Query!
State/province [92]
0
0
Lund
Query!
Country [93]
0
0
Sweden
Query!
State/province [93]
0
0
Uppsala
Query!
Country [94]
0
0
Sweden
Query!
State/province [94]
0
0
Västerås
Query!
Country [95]
0
0
Sweden
Query!
State/province [95]
0
0
Växjö
Query!
Country [96]
0
0
Taiwan
Query!
State/province [96]
0
0
Chiayi
Query!
Country [97]
0
0
Taiwan
Query!
State/province [97]
0
0
Keelung
Query!
Country [98]
0
0
Taiwan
Query!
State/province [98]
0
0
Tainan
Query!
Country [99]
0
0
Taiwan
Query!
State/province [99]
0
0
Taipei
Query!
Country [100]
0
0
Taiwan
Query!
State/province [100]
0
0
Taoyuan
Query!
Country [101]
0
0
United Kingdom
Query!
State/province [101]
0
0
Belfast
Query!
Country [102]
0
0
United Kingdom
Query!
State/province [102]
0
0
Bristol
Query!
Country [103]
0
0
United Kingdom
Query!
State/province [103]
0
0
Cardiff
Query!
Country [104]
0
0
United Kingdom
Query!
State/province [104]
0
0
Guildford
Query!
Country [105]
0
0
United Kingdom
Query!
State/province [105]
0
0
Leicester
Query!
Country [106]
0
0
United Kingdom
Query!
State/province [106]
0
0
London
Query!
Country [107]
0
0
United Kingdom
Query!
State/province [107]
0
0
Maidstone
Query!
Country [108]
0
0
United Kingdom
Query!
State/province [108]
0
0
Manchester
Query!
Country [109]
0
0
United Kingdom
Query!
State/province [109]
0
0
Oxford
Query!
Country [110]
0
0
United Kingdom
Query!
State/province [110]
0
0
Sutton
Query!
Country [111]
0
0
United Kingdom
Query!
State/province [111]
0
0
Wolverhampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Amgen
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01001377
Query!
Trial related presentations / publications
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
MD
Query!
Address
0
0
Amgen
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01001377
Download to PDF