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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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
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
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
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
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
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
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)
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
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
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
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)
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
Sex
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
2/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/03/2017
Sample size
Target
Accrual to date
Final
1010
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
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
State/province [7] 0 0
Sofia
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
Nova Scotia
Country [10] 0 0
China
State/province [10] 0 0
Guangdong
Country [11] 0 0
China
State/province [11] 0 0
Heilongjiang
Country [12] 0 0
China
State/province [12] 0 0
Hunan
Country [13] 0 0
China
State/province [13] 0 0
Jiangsu
Country [14] 0 0
China
State/province [14] 0 0
Jilin
Country [15] 0 0
China
State/province [15] 0 0
Shaanxi
Country [16] 0 0
China
State/province [16] 0 0
Shanghai
Country [17] 0 0
China
State/province [17] 0 0
Sichuan
Country [18] 0 0
China
State/province [18] 0 0
Zhejiang
Country [19] 0 0
China
State/province [19] 0 0
Beijing
Country [20] 0 0
China
State/province [20] 0 0
Tianjin
Country [21] 0 0
Czechia
State/province [21] 0 0
Horovice
Country [22] 0 0
Czechia
State/province [22] 0 0
Nova Ves pod Plesi
Country [23] 0 0
Czechia
State/province [23] 0 0
Olomouc
Country [24] 0 0
Czechia
State/province [24] 0 0
Praha 10
Country [25] 0 0
Czechia
State/province [25] 0 0
Pribram
Country [26] 0 0
Czechia
State/province [26] 0 0
Znojmo
Country [27] 0 0
France
State/province [27] 0 0
Besançon Cedex
Country [28] 0 0
France
State/province [28] 0 0
Montbéliard
Country [29] 0 0
France
State/province [29] 0 0
Saint Brieuc
Country [30] 0 0
France
State/province [30] 0 0
Saint Herblain
Country [31] 0 0
France
State/province [31] 0 0
Villejuif cedex
Country [32] 0 0
Hong Kong
State/province [32] 0 0
Kowloon
Country [33] 0 0
Hong Kong
State/province [33] 0 0
New Territories
Country [34] 0 0
India
State/province [34] 0 0
Andhra Pradesh
Country [35] 0 0
India
State/province [35] 0 0
Kerala
Country [36] 0 0
India
State/province [36] 0 0
Maharashtra
Country [37] 0 0
India
State/province [37] 0 0
Rajasthan
Country [38] 0 0
India
State/province [38] 0 0
Tamil Nadu
Country [39] 0 0
India
State/province [39] 0 0
West Bengal
Country [40] 0 0
Israel
State/province [40] 0 0
Beer Sheva
Country [41] 0 0
Israel
State/province [41] 0 0
Jerusalem
Country [42] 0 0
Israel
State/province [42] 0 0
Kfar Saba
Country [43] 0 0
Israel
State/province [43] 0 0
Ramat Gan
Country [44] 0 0
Israel
State/province [44] 0 0
Rehovot
Country [45] 0 0
Italy
State/province [45] 0 0
Ancona
Country [46] 0 0
Italy
State/province [46] 0 0
Cesena
Country [47] 0 0
Italy
State/province [47] 0 0
Cremona
Country [48] 0 0
Italy
State/province [48] 0 0
Faenza RA
Country [49] 0 0
Italy
State/province [49] 0 0
Genova
Country [50] 0 0
Italy
State/province [50] 0 0
Lugo
Country [51] 0 0
Italy
State/province [51] 0 0
Meldola FC
Country [52] 0 0
Italy
State/province [52] 0 0
Ravenna
Country [53] 0 0
Italy
State/province [53] 0 0
Rimini
Country [54] 0 0
Italy
State/province [54] 0 0
Torino
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Korea, Republic of
State/province [55] 0 0
Goyang-si, Gyeonggi-do
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Seoul
Country [57] 0 0
Latvia
State/province [57] 0 0
Daugavpils
Country [58] 0 0
Latvia
State/province [58] 0 0
Riga
Country [59] 0 0
Lithuania
State/province [59] 0 0
Kaunas
Country [60] 0 0
Lithuania
State/province [60] 0 0
Vilnius
Country [61] 0 0
Malaysia
State/province [61] 0 0
Kelantan
Country [62] 0 0
Malaysia
State/province [62] 0 0
Sabah
Country [63] 0 0
Malaysia
State/province [63] 0 0
Wilayah Persekutuan
Country [64] 0 0
Netherlands
State/province [64] 0 0
Rotterdam
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Peru
State/province [65] 0 0
Lima
Country [66] 0 0
Philippines
State/province [66] 0 0
Cebu City
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Philippines
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Manila
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Philippines
State/province [68] 0 0
Quezon City
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Poland
State/province [69] 0 0
Elblag
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Poland
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Gdansk
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Poland
State/province [71] 0 0
Jelenia Gora
Country [72] 0 0
Poland
State/province [72] 0 0
Poznan
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Poland
State/province [73] 0 0
Szczecin
Country [74] 0 0
Poland
State/province [74] 0 0
Warszawa
Country [75] 0 0
Romania
State/province [75] 0 0
Bucharest
Country [76] 0 0
Romania
State/province [76] 0 0
Sibiu
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Moscow
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Saint Petersburg
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Saint-Petersburg
Country [80] 0 0
Serbia
State/province [80] 0 0
Nis
Country [81] 0 0
Serbia
State/province [81] 0 0
Sremska Kamenica
Country [82] 0 0
Singapore
State/province [82] 0 0
Singapore
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Slovakia
State/province [83] 0 0
Bardejov
Country [84] 0 0
Slovakia
State/province [84] 0 0
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
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Sweden
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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
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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
State/province [103] 0 0
Cardiff
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Guildford
Country [105] 0 0
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01001377