Colorectal Cancer MetastaticNCT02135757
Study to Evaluate Real-world Pharmacoeconomics and Resistance Mechanisms of Panitumumab in Metastatic Colorectal Cancer Patients
An observational study of Colorectal Cancer Metastatic, run by PeriPharm at 2 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- How many people
- 23 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2014to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chemotherapy-refractory metastatic colorectal cancer from participating hospitals in Quebec.
Who may be able to join
- 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.
Who cannot join
- Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hôpital Charles-Le Moyne
Greenfield Park, Quebec, J4V 2H1
Jewish General Hospital
Montreal, Quebec, H3T 1E2
About this study
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
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).
Read more
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.
- Conditions
- Colorectal Cancer Metastatic
What is being measured
The primary outcome is the main question the study is designed to answer.
The pharmacoeconomic impact of panitumumab for the treatment of metastatic colorectal cancer in a real-life setting
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.
Measured: From the date of registration until date of death from any cause, assessed up to 38 months.
Secondary outcomes (1)
Identification of blood biomarkers that confer significant improvement in progression-free survival in patients treated with panitumumab.
Plasma will be isolated from patients pre-treatment, at every disease assessment and at progression of disease.
Measured: From the date of registration until the date of disease progression, assessed up to 24 months (estimation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- PeriPharm
- Sponsor type
- University, hospital or other
- Collaborators
- Personalized Medicine Partnership for Cancer
- Responsible party
- Sponsor
- Investigators
- Jean Lachaine, PhD, Principal investigator, PeriPharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135757
- Sponsor's protocol ID
- PMPC-02
- Status last verified
- Mar 2018
- First submitted
- 8 May 2014
- Last updated
- 30 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02135757
- Acronym / sponsor ID
- PMPC-02
- Conditions
- Colorectal Cancer Metastatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- PeriPharmUniversity, hospital or other
- Collaborators
- Personalized Medicine Partnership for Cancer
- Study start
- Aug 2014
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 12 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chemotherapy-refractory metastatic colorectal cancer from participating hospitals in Quebec.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (1 listed)
- Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Lachaine, PhD principal investigator
PeriPharm
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Metastatic, run by PeriPharm at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2018.