Wild-type RAS Metastatic Colorectal CancerNCT01732783

Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients

An observational study of Wild-type RAS Metastatic Colorectal Cancer, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective was to describe the pattern of use of panitumumab (Vectibix®) in combination with chemotherapy in patients with wild-type rat sarcoma viral oncogene homolog (RAS) metastatic colorectal cancer (mCRC): as first-line treatment in combination with FOLFOX or FOLFIRI or second-line treatment in… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Wild-type RAS Metastatic Colorectal Cancer
What is being tested?: Panitumumab + Chemotherapy
How many people: 213 participants
Where: No sites listed yet
Study dates: 10 Dec 2012to 30 Nov 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: All treatment centres (inpatient and outpatient) with a focus on treating patients with mCRC. Centres will be selected to represent academic, oncology and specialist settings and to provide geographical diversity in France and Germany.

Who may be able to join

Subject is ≥ 18 years of age at date of enrolment
Histologically or cytologically confirmed carcinoma of colon or rectum
Subject with metastatic carcinoma of colon or rectum
Confirmed wild-type RAS status of tumour
Subjects whose care will be managed primarily by the enrolling physician and/ or all records will be available
Tumour assessment (ie, computed tomography [CT]/magnetic resonance imaging [MRI]) within 12 weeks (84 days) prior to first Vectibix® infusion.

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Subjects treated with at least one infusion of Vectibix® in combination with chemotherapy a maximum of 84 days before entering study: first-line in combination with FOLFOX (folinic acid, leucovorin, fluorouracil [5FU], oxaliplatin) or second-line in combination with FOLFIRI (folinic acid, leucovorin, 5FU, irinotecan) in subjects who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) for treatment of wild-type RAS mCRC per approved prescribing information
Subject or subject's legally acceptable representative has provided informed consent (for countries where required per local regulations)
Subjects treated with Vectibix® in accordance with the current version of the Summary of Product Characteristics (SmPC)

Who cannot join

Ongoing or planned concurrent participation in any clinical study involving Investigational Product that has not been approved by the European Medicines Agency for any indication
Ongoing or planned concurrent participation in any clinical study where the dosing of Vectibix® is determined by the protocol (participation in clinical trials on an approved drug and observational trials are permitted but these cannot mandate how mCRC should be treated)

About this study

Official title: Prospective Observational Cohort Study to Describe the Use of Vectibix® in Combination With Chemotherapy in Routine Clinical Practice for Patients With Wild-type RAS Metastatic Colorectal Cancer

Conditions: Wild-type RAS Metastatic Colorectal Cancer
Being tested: Panitumumab + Chemotherapy
Keywords: Wild-type RAS, Metastatic Colorectal Cancer, Vectibix
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Panitumumab + ChemotherapyOther
Also called Vectibix®
Participants receiving panitumumab in combination with chemotherapy as prescribed by the treating physician prior to enrollment in this study and according to routine clinical practice for patients with wild-type RAS metastatic colorectal cancer.

Study groups in NCT01732783
Study group	Role	What they receive
Metastatic Colorectal Cancer		Participants with wild-type RAS metastatic colorectal cancer who were receiving panitumumab in combination with chemotherapy. Receives: Other: Panitumumab + Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Number of Panitumumab Infusions
Measured: 12 months
Cumulative Dose of Panitumumab
Measured: 12 months
Maximum Dose of Panitumumab
Measured: 12 months
Duration of Panitumumab Exposure
Duration of exposure is the time from the first to the last panitumumab infusion
Measured: 12 months
Mean Interval Between Panitumumab Infusions
Measured: 12 months
Percentage of Participants With at Least One Panitumumab Dose Reduction
Measured: 12 months
Percentage of Participants With at Least One Panitumumab Dose Delay
Measured: 12 months
Reasons for Discontinuation of Panitumumab
Measured: 12 months
Duration of Exposure of All Concomitant Chemotherapy
Duration of exposure is the time from the first date to the last date of chemotherapy administration.
Measured: 12 months
Percentage of Participants With at Least One Concomitant Chemotherapy Dose Reduction
Measured: 12 months
Percentage of Participants With at Least One Concomitant Chemotherapy Dose Delay
Measured: 12 months

Secondary outcomes (8)

Number of Participants With at Least One Hospitalization
Measured: 12 months
Types of Hospital Visit
Participants may have had more than one type of hospital visit.
Measured: 12 months
Duration of Hospital Stay
Measured: 12 months
Reasons for Hospitalization
Participants may have had more than one hospital visit and/or reason for a hospital visit.
Measured: 12 months
Percentage of Participants With an Overall Response
Tumor response was assessed by the investigator using standard radiological imaging. Overall response is defined as a best tumor response of complete response or partial response according to Response Evaluation Criteria In Solid Tumours (RECIST).
Measured: 12 months
Number of Participants With Resectability
Resectability denotes whether a participant became resectable during the study.
Measured: 12 months
Number of Participants With Anti-cancer Treatment After Panitumumab Discontinuation
Measured: 12 months
Type of Post-Panitumumab Anti-cancer Treatment
Participants may have received more than one type of anti-cancer treatment that was initiated after panitumumab discontinuation.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Dec 201230 Nov 2016

First posted26 Nov 2012 (estimated)
Study start10 Dec 2012
Primary completion30 Nov 2016
Study completion30 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Wild-type RAS Metastatic Colorectal CancerStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
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: 213 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01732783
Sponsor's protocol ID: 20120100
Status last verified: Nov 2022
First submitted: 20 Nov 2012
Last updated: 8 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingObservational study
Real-World Study: Panitumumab N01 vs Cetuximab Plus FOLFOX in First-Line RAS Wild-Type mCRC
Colorectal Cancer Metastatic
RecruitingPhase 3
Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1)
Left-sided Colorectal Cancer
RecruitingPhase 3
Study of Petosemtamab Plus Chemotherapy Versus Cetuximab or Bevacizumab Plus Chemotherapy in RAS and BRAF Wild Type, Recurrent, Unresectable or Metastatic Colorectal Cancer (LiGeR-CRC2)
Colorectal Cancer
Not yet recruitingObservational study
Real-World Treatment Patterns and Effectiveness of Anti-EGFR- and Anti-VEGF-based Therapies in Left-sided RAS Wild-Type Metastatic Colorectal Cancer
Metastatic Colorectal Cancer
RecruitingPhase 2
Toripalimab Plus Cetuximab and Irinotecan for Second-Line Right-Sided RAS/BRAF Wild-Type Advanced Colon Cancer Phase II Study
Colorectal Cancer (CRC)

All Wild-type RAS Metastatic Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Observational Cohort Study to Describe the Use of Vectibix® in Combination With Chemotherapy in Routine Clinical Practice for Patients With Wild-type RAS Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT01732783
Acronym / sponsor ID: 20120100
Conditions: Wild-type RAS Metastatic Colorectal Cancer
Keywords: Wild-type RAS, Metastatic Colorectal Cancer, Vectibix
Study type: Observational
Recruitment status: Completed
Enrolment: 213 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 10 Dec 2012 (actual)
Primary completion: 30 Nov 2016 (actual)
Study completion: 30 Nov 2016 (actual)
First posted: 26 Nov 2012 (estimated)
Results: Posted 20 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Metastatic Colorectal Cancer	–	Other: Panitumumab + ChemotherapyParticipants with wild-type RAS metastatic colorectal cancer who were receiving panitumumab in combination with chemotherapy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All treatment centres (inpatient and outpatient) with a focus on treating patients with mCRC. Centres will be selected to represent academic, oncology and specialist settings and to provide geographical diversity in France and Germany.

Key inclusion criteria (9 listed)

Subject is ≥ 18 years of age at date of enrolment
Histologically or cytologically confirmed carcinoma of colon or rectum
Subject with metastatic carcinoma of colon or rectum
Confirmed wild-type RAS status of tumour
Subjects whose care will be managed primarily by the enrolling physician and/ or all records will be available

Key exclusion criteria (2 listed)

Ongoing or planned concurrent participation in any clinical study involving Investigational Product that has not been approved by the European Medicines Agency for any indication
Ongoing or planned concurrent participation in any clinical study where the dosing of Vectibix® is determined by the protocol (participation in clinical trials on an approved drug and observational trials are permitted but these cannot mandate how mCRC should be treated)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Panitumumab + ChemotherapyAlso: Vectibix®Participants receiving panitumumab in combination with chemotherapy as prescribed by the treating physician prior to enrollment in this study and according to routine clinical practice for patients with wild-type RAS metastatic colorectal cancer.	Other	Metastatic Colorectal Cancer

Primary outcome

Total Number of Panitumumab Infusions
Time frame: 12 months
Cumulative Dose of Panitumumab
Time frame: 12 months
Maximum Dose of Panitumumab
Time frame: 12 months
Duration of Panitumumab Exposure
Time frame: 12 months
Duration of exposure is the time from the first to the last panitumumab infusion
Mean Interval Between Panitumumab Infusions
Time frame: 12 months
Percentage of Participants With at Least One Panitumumab Dose Reduction
Time frame: 12 months
Percentage of Participants With at Least One Panitumumab Dose Delay
Time frame: 12 months
Reasons for Discontinuation of Panitumumab
Time frame: 12 months
Duration of Exposure of All Concomitant Chemotherapy
Time frame: 12 months
Duration of exposure is the time from the first date to the last date of chemotherapy administration.
Percentage of Participants With at Least One Concomitant Chemotherapy Dose Reduction
Time frame: 12 months
Percentage of Participants With at Least One Concomitant Chemotherapy Dose Delay
Time frame: 12 months

8 secondary outcomes

Number of Participants With at Least One Hospitalization
Time frame: 12 months
Types of Hospital Visit
Time frame: 12 months
Duration of Hospital Stay
Time frame: 12 months
Reasons for Hospitalization
Time frame: 12 months
Percentage of Participants With an Overall Response
Time frame: 12 months
Number of Participants With Resectability
Time frame: 12 months
Number of Participants With Anti-cancer Treatment After Panitumumab Discontinuation
Time frame: 12 months
Type of Post-Panitumumab Anti-cancer Treatment
Time frame: 12 months

Results and safety

Results posted to the registry on 20 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Panitumumab + FOLFOX First-line	164	29
Panitumumab + FOLFIRI Second-line	37	5
Panitumumab + FOLFIRI First-line	12	2

Primary outcome: Total Number of Panitumumab Infusions

Time frame: 12 months. Median (Inter-Quartile Range). Unit: infusions

Measure	Panitumumab + FOLFOX First-line n = 164	Panitumumab + FOLFIRI Second-line n = 37	Panitumumab + FOLFIRI First-line n = 12
Value	10.0 (6.0 to 16.0)	10.0 (6.0 to 16.0)	8.0 (4.0 to 15.5)

Primary outcome: Cumulative Dose of Panitumumab

Time frame: 12 months. Median (Inter-Quartile Range). Unit: mg

Measure	Panitumumab + FOLFOX First-line n = 164	Panitumumab + FOLFIRI Second-line n = 37	Panitumumab + FOLFIRI First-line n = 12
Value	4262.5 (2311.5 to 6902.5)	4000.0 (2400.0 to 6000.0)	3782.5 (1772.5 to 5751.0)

Primary outcome: Maximum Dose of Panitumumab

Time frame: 12 months. Median (Inter-Quartile Range). Unit: mg

Measure	Panitumumab + FOLFOX First-line n = 164	Panitumumab + FOLFIRI Second-line n = 37	Panitumumab + FOLFIRI First-line n = 12
Value	450.0 (380.0 to 520.0)	420.0 (390.0 to 500.0)	507.0 (424.0 to 590.0)

Primary outcome: Duration of Panitumumab Exposure

Time frame: 12 months. Median (Inter-Quartile Range). Unit: months

Measure	Panitumumab + FOLFOX First-line n = 164	Panitumumab + FOLFIRI Second-line n = 37	Panitumumab + FOLFIRI First-line n = 12
Value	5.339 (2.546 to 10.053)	6.012 (2.464 to 8.246)	5.339 (1.922 to 12.008)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Panitumumab + FOLFOX First-line	10 of 164 (6.1%)	101 of 164 (61.6%)	0 of 164
Panitumumab + FOLFIRI Second-line	0 of 37 (0%)	25 of 37 (67.6%)	0 of 37
Panitumumab + FOLFIRI First-line	0 of 12 (0%)	8 of 12 (66.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Related trials for Wild-type RAS Metastatic Colorectal Cancer

Not yet recruitingObservational study
Real-World Study: Panitumumab N01 vs Cetuximab Plus FOLFOX in First-Line RAS Wild-Type mCRC
Colorectal Cancer Metastatic
RecruitingPhase 3
Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1)
Left-sided Colorectal Cancer
RecruitingPhase 3
Study of Petosemtamab Plus Chemotherapy Versus Cetuximab or Bevacizumab Plus Chemotherapy in RAS and BRAF Wild Type, Recurrent, Unresectable or Metastatic Colorectal Cancer (LiGeR-CRC2)
Colorectal Cancer
Not yet recruitingObservational study
Real-World Treatment Patterns and Effectiveness of Anti-EGFR- and Anti-VEGF-based Therapies in Left-sided RAS Wild-Type Metastatic Colorectal Cancer
Metastatic Colorectal Cancer
RecruitingPhase 2
Toripalimab Plus Cetuximab and Irinotecan for Second-Line Right-Sided RAS/BRAF Wild-Type Advanced Colon Cancer Phase II Study
Colorectal Cancer (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.

MD study director

Amgen

Questions about this trial

What is this clinical trial studying?

An observational study of Wild-type RAS Metastatic Colorectal Cancer, run by Amgen.

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 9 inclusion and 2 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 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 20 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Total Number of Panitumumab Infusions (time frame: 12 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01732783.

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 8 Nov 2022.