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Study to Evaluate Real-world Pharmacoeconomics and Resistance Mechanisms of Panitumumab in Metastatic Colorectal Cancer Patients

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ClinicalTrials.gov Identifier: NCT02135757
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : March 30, 2018
Sponsor:
Collaborator:
Personalized Medicine Partnership for Cancer
Information provided by (Responsible Party):
PeriPharm

Tracking Information
First Submitted Date May 8, 2014
First Posted Date May 12, 2014
Last Update Posted Date March 30, 2018
Study Start Date August 2014
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 8, 2014)
The pharmacoeconomic impact of panitumumab for the treatment of metastatic colorectal cancer in a real-life setting [ Time Frame: From the date of registration until date of death from any cause, assessed up to 38 months. ]
Pharmacoeconomic impact (cost-effectiveness and cost-utility) will be evaluated by questionnaires completed by the patient and caregiver. These include quality of life, health resource utilization, work productivity and activity impairment, and health questionnaires.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 8, 2014)
Identification of blood biomarkers that confer significant improvement in progression-free survival in patients treated with panitumumab. [ Time Frame: From the date of registration until the date of disease progression, assessed up to 24 months (estimation). ]
Plasma will be isolated from patients pre-treatment, at every disease assessment and at progression of disease.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study to Evaluate Real-world Pharmacoeconomics and Resistance Mechanisms of Panitumumab in Metastatic Colorectal Cancer Patients
Official Title A Phase IV Multicenter Trial to Evaluate Real-world Health Outcomes, Economic Impact and Resistance Mechanisms of Panitumumab in the Treatment of Patients With Chemotherapy-refractory Metastatic Colorectal Cancer
Brief Summary

This is a phase IV multicenter trial to evaluate real-world health outcomes, economic impact and resistance mechanisms of panitumumab in the treatment of patients with chemotherapy-refractory metastatic colorectal cancer (mCRC).

This study will address two anticipated issues surrounding personalized medicine and treatment with panitumumab. First, it will enable to assess the economic impact of panitumumab in a real-life setting (HEOR study). Second, it will identify new blood-based mechanisms of resistance, which may lead to new avenues for combination therapy in metastatic colorectal cancer (Blood study).

The primary objective is to collect information on quality of life and health care resource utilization by patients diagnosed with metastatic colorectal cancer. The secondary objectives are to confirm survival data, to assess the quality of life of patients and to assess the health care resource utilization of patients. The blood biomarker study objective is to determine blood-based biomarkers of response or resistance to panitumumab.

Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and will participate to the HEOR study only. Patients with a non-mutated (wild type) KRAS gene will be treated with panitumumab and will participate to the HEOR study and to the blood biomarker study.

During the course of the study, data will be collected on quality of life and work productivity. Patients will be asked to fill a set of questionnaires at their recruitment in the study and at every 3 months after treatment initiation. For patients participating to the blood study (patients with a wild type KRAS), blood samples will be collected before patients start their treatment, at every treatment and when they discontinue their treatment.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with chemotherapy-refractory metastatic colorectal cancer from participating hospitals in Quebec.
Condition Colorectal Cancer Metastatic
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 13, 2016)
23
Original Estimated Enrollment
 (submitted: May 8, 2014)
40
Actual Study Completion Date March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with a histologically confirmed diagnosis of mCRC.
  • Immunohistochemical evidence of EGFR expression.
  • ECOG performance status of 0, 1 or 2.
  • Patients refractory to fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens
  • Patients with a wt KRAS scheduled to receive panitumumab as a single agent for the third-line treatment of mCRC or patients with a mt KRAS scheduled to receive SOC for third-line treatment of mCRC.
  • Signed and dated IRB-approved informed consent document.
  • Ability to read and understand English or French.
  • 18 years of age or older.

Exclusion Criteria:

  • Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02135757
Other Study ID Numbers PMPC-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party PeriPharm
Study Sponsor PeriPharm
Collaborators Personalized Medicine Partnership for Cancer
Investigators
Principal Investigator: Jean Lachaine, PhD PeriPharm
PRS Account PeriPharm
Verification Date March 2018