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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01001377
Recruitment Status : Completed
First Posted : October 26, 2009
Results First Posted : March 24, 2014
Last Update Posted : December 26, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE October 22, 2009
First Posted Date  ICMJE October 26, 2009
Results First Submitted Date  ICMJE February 3, 2014
Results First Posted Date  ICMJE March 24, 2014
Last Update Posted Date December 26, 2018
Actual Study Start Date  ICMJE February 2, 2010
Actual Primary Completion Date February 5, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
To compare the effect of panitumumab versus cetuximab on overall survival for chemorefractory mCRC among subjects with wild-type KRAS tumors. [ Time Frame: 4 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2014)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
To compare progression-free survival, objective response rate, time to response, time to treatment failure, duration of response, safety and patient reported outcomes of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumors. [ Time Frame: 4 years. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • Drug: Cetuximab
    Administered by intravenous infusion
    Other Name: Erbitux
  • Drug: Panitumumab
    Administered by intravenous infusion
    Other Name: Vectibix
Study Arms  ICMJE
  • 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.

    Intervention: Drug: Cetuximab
  • Experimental: Panitumumab
    Panitumumab 6 mg/kg IV every 14 days. Participants were treated until disease progression, intolerability, withdrawal of consent, or death.
    Intervention: Drug: Panitumumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2014)
1010
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2009)
1000
Actual Study Completion Date  ICMJE March 7, 2017
Actual Primary Completion Date February 5, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Bulgaria,   Canada,   China,   Czechia,   France,   Hong Kong,   India,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Netherlands,   Peru,   Philippines,   Poland,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovakia,   South Africa,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01001377
Other Study ID Numbers  ICMJE 20080763
ASPECCT
2009-010715-32 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP