Advanced or Recurrent Colorectal CancerNCT02089737

Panitumumab for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance "Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene" (All-patient Surveillance)

An observational study of Advanced or Recurrent Colorectal Cancer, run by Takeda.

Completed

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

Trial summary

The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied. Specifically, information will be collected on the following as events of interest: skin disorders, interstitial lung disease, infusion reactions, electrolyte abnormalities, and cardiac disorders. Read more about this study

Who is it for?: Any age
Conditions the study is for: Advanced or Recurrent Colorectal Cancer
What is being tested?: Panitumumab
Type of treatment: Injection or infusion
How many people: 3,091 participants
Where: No sites listed yet
Study dates: Jun 2010to Jul 2012
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS gene

Who may be able to join

Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS gene

Who cannot join

Patients with a medical history of severe hypersensitivity to any of the ingredients of Vectibix

About this study

Official title: Vectibix for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance "Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene" (All-patient Surveillance)

The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied.

Specifically, information will be collected on the following as events of interest: skin disorders, interstitial lung disease, infusion reactions, electrolyte abnormalities, and cardiac disorders.

Read the detailed description

The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied.

Participants of this surveillance will be patients with unresectable, advanced or recurrent colorectal cancer with the wild-type KRAS gene. The planned sample size is 2,000 patients.

The usual adult dosage is 6 mg/kg of panitumumab given by intravenous drip infusion over a 60-minute period once every 2 weeks. The dosage may also be reduced as needed, depending on the patient's condition.

Conditions: Advanced or Recurrent Colorectal Cancer
Being tested: Panitumumab
Medical subject headings: Colorectal Neoplasms

What participants receive

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

PanitumumabDrug
Also called Vectibix
Panitumumab for intravenous infusion

Study groups in NCT02089737
Study group	Role	What they receive
Panitumumab 6 mg/kg		Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks Receives: Drug: Panitumumab

What is being measured

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

Number of Participants With Adverse Drug Reactions
The number of participants with adverse drug reactions reported during the observation period were tabulated by type, seriousness, and time of onset. . Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.
Measured: Baseline through Week 42

Secondary outcomes (2)

Progression-free Survival
Progression-free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.
Measured: Up to Week 42 or death (whichever occurred first)
Overall Survival
Overall survival was defined as the time to death from the start of panitumumab administration was tabulated.
Measured: Up to Week 42 or death (whichever occurred first)

Timeline

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

Jun 2010Jul 2012

First posted18 Mar 2014 (estimated)
Study startJun 2010
Primary completionJul 2012
Study completionJul 2012

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 Advanced or Recurrent Colorectal CancerStudies of the same condition, open and under way.
More trials run by TakedaThe 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: 3,091 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02089737
Sponsor's protocol ID: 183-011
Other IDs: JapicCTI-132374, JapicCTI-R140654
Status last verified: Feb 2017
First submitted: 13 Mar 2014
Last updated: 6 Apr 2017
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

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All Advanced or Recurrent Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vectibix for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance "Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene" (All-patient Surveillance)
ClinicalTrials.gov ID: NCT02089737
Acronym / sponsor ID: 183-011
Conditions: Advanced or Recurrent Colorectal Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 3,091 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 18 Mar 2014 (estimated)
Results: Posted 6 Apr 2017

Clinical summary

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

The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied.

Specifically, information will be collected on the following as events of interest: skin disorders, interstitial lung disease, infusion reactions, electrolyte abnormalities, and cardiac disorders.

Detailed description

The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied.

Participants of this surveillance will be patients with unresectable, advanced or recurrent colorectal cancer with the wild-type KRAS gene. The planned sample size is 2,000 patients.

Study design

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

Arm	Type	Receives
Panitumumab 6 mg/kg	–	Drug: PanitumumabPanitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS gene

Key inclusion criteria (1 listed)

Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS gene

Key exclusion criteria (1 listed)

Patients with a medical history of severe hypersensitivity to any of the ingredients of Vectibix

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
PanitumumabAlso: VectibixPanitumumab for intravenous infusion	Drug	Panitumumab 6 mg/kg

Primary outcome

Number of Participants With Adverse Drug Reactions
Time frame: Baseline through Week 42
The number of participants with adverse drug reactions reported during the observation period were tabulated by type, seriousness, and time of onset. . Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.

2 secondary outcomes

Progression-free Survival
Time frame: Up to Week 42 or death (whichever occurred first)
Overall Survival
Time frame: Up to Week 42 or death (whichever occurred first)

Results and safety

Results posted to the registry on 6 Apr 2017, 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	3,091	3,085

Primary outcome: Number of Participants With Adverse Drug Reactions

Time frame: Baseline through Week 42. Number. Unit: Participants

Measure	Panitumumab n = 3085
Frequency of adverse drug reactions	2595
MedDRA SOC: Skin and subcutaneous tissue disorders	2364
MedDRA SOC: Infections and infestations	771
MedDRA SOC: Gastrointestinal disorders	642
MedDRA SOC: Metabolism and nutrition disorders	552
MedDRA SOC: Cardiac disorders	7

Population analysed: Of the 3086 participants who completed the survey form, 3085 participants were included in the safety analysis set after excluding 1 participant for whom information regarding panitumumab treatment and adverse events were missing.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: For up to 42 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Panitumumab	614 of 1,254 (49%)	640 of 1,254 (51%)	Not reported
Concomitant Administration of Panitumumab and Chemotherapy	747 of 1,831 (40.8%)	1,084 of 1,831 (59.2%)	Not reported

Limitations and caveats (from the sponsor): The present specified drug-use survey is a one-arm observational study with no control group. Therefore, the observed outcome measures provide exploratory information regarding these endpoints; however, do not constitute verification results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Advanced or Recurrent Colorectal Cancer

Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 1
Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer
Colorectal Cancer
Active, not recruitingPhase 2
Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in Patients With Prostate, Cervical, or Rectal Cancers
Localized Prostate Carcinoma, Locally Advanced Cervical Carcinoma
RecruitingPhase 1/2
Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer
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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.

Postmarketing Group Manager study chair

Takeda

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced or Recurrent Colorectal Cancer, run by Takeda.

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 1 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 6 Apr 2017. 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 6 Apr 2017). 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?

Number of Participants With Adverse Drug Reactions (time frame: Baseline through Week 42). 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 NCT02089737.

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 6 Apr 2017.