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

September 8, 2022 updated by: Amgen

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1010

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Research Site
      • St Leonards, New South Wales, Australia, 2065
        • Research Site
      • Wahroonga, New South Wales, Australia, 2076
        • Research Site
      • Wollongong, New South Wales, Australia, 2500
        • Research Site
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • Research Site
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Research Site
      • Box Hill, Victoria, Australia, 3128
        • Research Site
      • Epping, Victoria, Australia, 3076
        • Research Site
      • Footscray, Victoria, Australia, 3011
        • Research Site
      • Heidelberg, Victoria, Australia, 3084
        • Research Site
      • Parkville, Victoria, Australia, 3050
        • Research Site
      • Edegem, Belgium, 2650
        • Research Site
      • Sofia, Bulgaria, 1784
        • Research Site
      • Sofia, Bulgaria, 1527
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Research Site
      • Beijing, China, 100142
        • Research Site
      • Beijing, China, 100021
        • Research Site
      • Beijing, China, 100071
        • Research Site
      • Shanghai, China, 200032
        • Research Site
      • Shanghai, China, 200080
        • Research Site
      • Shanghai, China, 200003
        • Research Site
      • Tianjin, China, 300060
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Research Site
      • Guangzhou, Guangdong, China, 510180
        • Research Site
      • Guangzhou, Guangdong, China, 510280
        • Research Site
      • Guangzhou, Guangdong, China, 515515
        • Research Site
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150040
        • Research Site
    • Hunan
      • Changsha, Hunan, China, 410013
        • Research Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Research Site
    • Jilin
      • Changchun, Jilin, China, 130012
        • Research Site
    • Shaanxi
      • XI An, Shaanxi, China, 710061
        • Research Site
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Research Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Research Site
      • Chongqing, Sichuan, China, 400038
        • Research Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Research Site
      • Hangzhou, Zhejiang, China, 310016
        • Research Site
      • Horovice, Czechia, 268 31
        • Research Site
      • Nova Ves pod Plesi, Czechia, 262 04
        • Research Site
      • Olomouc, Czechia, 775 20
        • Research Site
      • Praha 10, Czechia, 100 34
        • Research Site
      • Pribram, Czechia, 261 01
        • Research Site
      • Znojmo, Czechia, 669 02
        • Research Site
      • Besançon Cedex, France, 25030
        • Research Site
      • Montbéliard, France, 25200
        • Research Site
      • Saint Brieuc, France, 22015
        • Research Site
      • Saint Herblain, France, 44800
        • Research Site
      • Villejuif cedex, France, 94805
        • Research Site
      • Kowloon, Hong Kong
        • Research Site
      • New Territories, Hong Kong
        • Research Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 024
        • Research Site
      • Hyderabad, Andhra Pradesh, India, 500 034
        • Research Site
    • Kerala
      • Kochi, Kerala, India, 682 304
        • Research Site
    • Maharashtra
      • Ahmednagar, Maharashtra, India, 413 736
        • Research Site
      • Nagpur, Maharashtra, India, 440 012
        • Research Site
      • Nashik, Maharashtra, India, 422 005
        • Research Site
      • Nashik, Maharashtra, India, 422 004
        • Research Site
      • Pune, Maharashtra, India, 411 004
        • Research Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302 013
        • Research Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 018
        • Research Site
    • West Bengal
      • Kolkata, West Bengal, India, 700 016
        • Research Site
      • Beer Sheva, Israel, 64239
        • Research Site
      • Jerusalem, Israel, 91031
        • Research Site
      • Kfar Saba, Israel, 44281
        • Research Site
      • Ramat Gan, Israel, 52621
        • Research Site
      • Rehovot, Israel, 76100
        • Research Site
      • Ancona, Italy, 60131
        • Research Site
      • Cesena, Italy, 47023
        • Research Site
      • Cremona, Italy, 26100
        • Research Site
      • Faenza RA, Italy, 48018
        • Research Site
      • Genova, Italy, 16132
        • Research Site
      • Lugo, Italy, 48022
        • Research Site
      • Meldola FC, Italy, 47014
        • Research Site
      • Ravenna, Italy, 48100
        • Research Site
      • Rimini, Italy, 47900
        • Research Site
      • Torino, Italy, 10126
        • Research Site
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • Research Site
      • Seoul, Korea, Republic of, 135-710
        • Research Site
      • Seoul, Korea, Republic of, 120-752
        • Research Site
      • Seoul, Korea, Republic of, 138-736
        • Research Site
      • Seoul, Korea, Republic of, 110-744
        • Research Site
      • Seoul, Korea, Republic of, 136-705
        • Research Site
      • Daugavpils, Latvia, 5417
        • Research Site
      • Riga, Latvia, 1079
        • Research Site
      • Riga, Latvia, 1002
        • Research Site
      • Kaunas, Lithuania, 50009
        • Research Site
      • Vilnius, Lithuania, 08660
        • Research Site
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Research Site
    • Sabah
      • Kota Kinabalu, Sabah, Malaysia, 88996
        • Research Site
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000
        • Research Site
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
        • Research Site
      • Rotterdam, Netherlands, 3000 CA
        • Research Site
      • Lima, Peru, LIMA 27
        • Research Site
      • Lima, Peru, 13
        • Research Site
      • Lima, Peru, 34
        • Research Site
      • Cebu City, Philippines, 6000
        • Research Site
      • Manila, Philippines, 1000
        • Research Site
      • Quezon City, Philippines, 1102
        • Research Site
      • Elblag, Poland, 82-300
        • Research Site
      • Gdansk, Poland, 80-219
        • Research Site
      • Jelenia Gora, Poland, 58-506
        • Research Site
      • Poznan, Poland, 61-485
        • Research Site
      • Szczecin, Poland, 71-730
        • Research Site
      • Warszawa, Poland, 02-781
        • Research Site
      • Warszawa, Poland, 02-097
        • Research Site
      • Warszawa, Poland, 02-507
        • Research Site
      • Bucharest, Romania, 022328
        • Research Site
      • Sibiu, Romania, 550245
        • Research Site
      • Moscow, Russian Federation, 115478
        • Research Site
      • Moscow, Russian Federation, 117997
        • Research Site
      • Saint Petersburg, Russian Federation, 197022
        • Research Site
      • Saint-Petersburg, Russian Federation, 197758
        • Research Site
      • Saint-Petersburg, Russian Federation, 198255
        • Research Site
      • Nis, Serbia, 18000
        • Research Site
      • Sremska Kamenica, Serbia, 21204
        • Research Site
      • Singapore, Singapore, 119228
        • Research Site
      • Singapore, Singapore, 308433
        • Research Site
      • Bardejov, Slovakia, 085 01
        • Research Site
      • Bratislava, Slovakia, 831 01
        • Research Site
      • Nitra, Slovakia, 950 01
        • Research Site
      • Johannesburg, South Africa, 2193
        • Research Site
      • Port Elizabeth, South Africa, 6045
        • Research Site
    • Gauteng
      • Groenkloof, Gauteng, South Africa, 0181
        • Research Site
      • Johannesburg, Gauteng, South Africa, 2199
        • Research Site
    • Western Cape
      • Kraaifontein, Western Cape, South Africa, 7570
        • Research Site
      • Göteborg, Sweden, 416 85
        • Research Site
      • Linköping, Sweden, 581 85
        • Research Site
      • Lund, Sweden, 221 85
        • Research Site
      • Uppsala, Sweden, 751 85
        • Research Site
      • Västerås, Sweden, 721 89
        • Research Site
      • Växjö, Sweden, 351 85
        • Research Site
      • Keelung, Taiwan, 20401
        • Research Site
      • Tainan, Taiwan, 70403
        • Research Site
      • Taipei, Taiwan, 11031
        • Research Site
      • Taoyuan, Taiwan, 33305
        • Research Site
    • Chiayi
      • Putzu City, Chiayi, Taiwan, 61363
        • Research Site
      • Belfast, United Kingdom, BT9 7AB
        • Research Site
      • Bristol, United Kingdom, BS2 8ED
        • Research Site
      • Cardiff, United Kingdom, CF14 2TL
        • Research Site
      • Guildford, United Kingdom, GU2 7XX
        • Research Site
      • Leicester, United Kingdom, LE1 5WW
        • Research Site
      • London, United Kingdom, SW17 0QT
        • Research Site
      • Maidstone, United Kingdom, ME16 9QQ
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
      • Oxford, United Kingdom, OX3 7LJ
        • Research Site
      • Sutton, United Kingdom, SM2 5PT
        • Research Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Research Site
    • California
      • Stockton, California, United States, 95204
        • Research Site
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Research Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Research Site
    • Texas
      • Temple, Texas, United States, 76508
        • Research Site
    • Utah
      • Ogden, Utah, United States, 84403
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

Administered by intravenous infusion
Other Names:
  • Erbitux
Experimental: Panitumumab
Panitumumab 6 mg/kg IV every 14 days. Participants were treated until disease progression, intolerability, withdrawal of consent, or death.
Administered by intravenous infusion
Other Names:
  • Vectibix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
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.
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.

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.

From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Objective Response
Time Frame: From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
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.
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Duration of Response
Time Frame: From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
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.
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Time to Response
Time Frame: From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
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.
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Time to Treatment Failure
Time Frame: From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
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.
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score
Time Frame: From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
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.
From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS)
Time Frame: From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
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.
From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Change From Baseline in National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index (NCCN FCSI ) Symptoms Score
Time Frame: From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
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).
From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Change From Baseline in NCCN FCSI Physical Well-being Scale Score
Time Frame: From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
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).
From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Change From Baseline in NCCN FCSI Functional Well-being Scale Score
Time Frame: From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
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).
From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
Number of Participants With Adverse Events (AEs)
Time Frame: 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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2010

Primary Completion (Actual)

February 5, 2013

Study Completion (Actual)

March 7, 2017

Study Registration Dates

First Submitted

October 22, 2009

First Submitted That Met QC Criteria

October 22, 2009

First Posted (Estimate)

October 26, 2009

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 8, 2022

Last Verified

September 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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