Colorectal CancerPhase 1/2GEN206NCT00677924

Zalutumumab With or Without Irinotecan Chemotherapy in Cetuximab-Refractory Colorectal Cancer

A Phase 1/2 study testing Zalutumumab in people with Colorectal Cancer, run by Genmab at 3 sites in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this trial is to determine the safety and efficacy of Zalutumumab alone or in combination with Irinotecan for the treatment of patients with Colorectal Cancer Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer
What is being tested?: Zalutumumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 3 sitesBelgium
Study dates: Apr 2008to Apr 2009
Phase: Phase 1/2
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

Who may be able to join

Males and Females age ≥ 18 years
Confirmed diagnosis of CRC
Documented disease progression
Failure and/or intolerance to standard chemotherapy

Who cannot join

Prior treatment with anti-EGFR antibodies other than cetuximab
Expected survival < 3 months
Clinical significant cardiac disease and/or uncontrolled medical conditions

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

Institut Jules Bordet
Brussels, 1000
Hospital Erasme
Brussels, 1070
St-Luc University Hospital
Brussels, 1200

Other trials in Belgium

About this study

Official title: A Dose-Escalation, Randomized Phase I/II Trial of Zalutumumab - a Human Monoclonal Anti-EGF Receptor Antibody - With or Without Irinotecan Chemotherapy in Cetuximab Refractory Colorectal Cancer Patients Who Have Failed Standard Chemotherapy and Progressed During or Within 3 Months of Stopping Cetuximab-Based Therapy

The purpose of this trial is to determine the safety and efficacy of Zalutumumab alone or in combination with Irinotecan for the treatment of patients with Colorectal Cancer

Conditions: Colorectal Cancer
Being tested: Zalutumumab
Keywords: Colorectal Neoplasms, Colorectal Tumors, Colorectal Carcinoma
Medical subject headings: Colorectal Neoplasms

What participants receive

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

ZalutumumabDrug
Also called HuMax-EGFr
Solution for infusion

Study groups in NCT00677924
Study group	Role	What they receive
Zalutumumab 8 mg/kg	Experimental	Zalutumumab in combination with Irinotecan Receives: Drug: Zalutumumab
Zalutumumab 16 mg/kg	Experimental	Zalutumumab in combination with Irinotecan Receives: Drug: Zalutumumab

What is being measured

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

Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: From first dose up to follow-up (up to approximately 1 year)

Secondary outcomes (1)

Number of Participants With Best Overall Tumour Response (BOR)
The BOR defined as the best response recorded from the start of treatment until disease progression or recurrence per RECIST criteria. Complete response (CR) defined as the disappearance of all target lesions. Partial response (PR) defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Progressive disease (PD) defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions since the prior scan. Stable disease (SD) defined as responses not fulfilling CR, PR or PD.
Measured: Up to 1 year

Timeline

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

Apr 2008Apr 2009

First posted15 May 2008 (estimated)
Study startApr 2008
Primary completionApr 2009
Study completionApr 2009

Why it stopped: Due to changes in portfolio review

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by GenmabThe 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: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00677924
Sponsor's protocol ID: GEN206
Acronym: GEN206
Status last verified: Jul 2023
First submitted: 13 May 2008
Last updated: 18 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Mano M, Hendlisz A, Machiels JP, Ehrnrooth E, Aladdin H, Van Laethem JL. Phase I trial of zalutumumab and irinotecan in metastatic colorectal cancer patients who have failed irinotecan and cetuximab based therapy. J Clin Oncol 27 2009 (suppl;abstr e15028)

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?

See locations

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All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose-Escalation, Randomized Phase I/II Trial of Zalutumumab - a Human Monoclonal Anti-EGF Receptor Antibody - With or Without Irinotecan Chemotherapy in Cetuximab Refractory Colorectal Cancer Patients Who Have Failed Standard Chemotherapy and Progressed During or Within 3 Months of Stopping Cetuximab-Based Therapy
ClinicalTrials.gov ID: NCT00677924
Acronym / sponsor ID: GEN206 / GEN206
Conditions: Colorectal Cancer
Keywords: Colorectal Neoplasms, Colorectal Tumors, Colorectal Carcinoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to changes in portfolio review
Enrolment: 9 participants (actual)
Lead sponsor: GenmabIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 15 May 2008 (estimated)
Results: Posted 23 Dec 2011

Clinical summary

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

The purpose of this trial is to determine the safety and efficacy of Zalutumumab alone or in combination with Irinotecan for the treatment of patients with Colorectal Cancer

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Zalutumumab 8 mg/kg	Experimental	Drug: ZalutumumabZalutumumab in combination with Irinotecan
Zalutumumab 16 mg/kg	Experimental	Drug: ZalutumumabZalutumumab in combination with Irinotecan

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Males and Females age ≥ 18 years
Confirmed diagnosis of CRC
Documented disease progression
Failure and/or intolerance to standard chemotherapy

Key exclusion criteria (3 listed)

Prior treatment with anti-EGFR antibodies other than cetuximab
Expected survival < 3 months
Clinical significant cardiac disease and/or uncontrolled medical conditions

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
ZalutumumabAlso: HuMax-EGFrSolution for infusion	Drug	Zalutumumab 16 mg/kg, Zalutumumab 8 mg/kg

Primary outcome

Number of Participants With Adverse Events (AEs)
Time frame: From first dose up to follow-up (up to approximately 1 year)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

1 secondary outcome

Number of Participants With Best Overall Tumour Response (BOR)
Time frame: Up to 1 year

Results and safety

Results posted to the registry on 23 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zalatumumab 8 mg/kg	3	3
Zalutumumab 16 mg/kg	6	6

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: From first dose up to follow-up (up to approximately 1 year). Count of participants. Unit: Participants

Measure	Zalatumumab 8 mg/kg n = 3	Zalutumumab 16 mg/kg n = 6
Value	3	5

Population analysed: All participants who had been exposed to zalutumumab or irinotecan, irrespective of their compliance to the planned course of treatment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first dose up to follow-up (up to approximately 1 year). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zalatumumab 8 mg/kg	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
Zalutumumab 16 mg/kg	3 of 6 (50%)	5 of 6 (83.3%)	Not reported

Limitations and caveats (from the sponsor): The trial was prematurely closed when 9 out of 97 patients were enrolled. The trial design was originally divided in two parts. Patient allocation was terminated before Part 2 was started.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationMano M, Hendlisz A, Machiels JP, Ehrnrooth E, Aladdin H, Van Laethem JL. Phase I trial of zalutumumab and irinotecan in metastatic colorectal cancer patients who have failed irinotecan and cetuximab based therapy. J Clin Oncol 27 2009 (suppl;abstr e15028)

Related trials for Colorectal Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer

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.

Hassan Aladdin, ICTM study director

Genmab

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Zalutumumab in people with Colorectal Cancer, run by Genmab at 3 sites in Belgium.

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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2011). 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 Events (AEs) (time frame: From first dose up to follow-up (up to approximately 1 year)). 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 NCT00677924, which also lists 1 linked publication.

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 18 Jul 2023.