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Due to changes in portfolio review
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zalutumumab 8 mg/kg | Experimental | Zalutumumab in combination with Irinotecan |
|
| Zalutumumab 16 mg/kg | Experimental | Zalutumumab in combination with Irinotecan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zalutumumab | Drug | Solution for infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From first dose up to follow-up (up to approximately 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hassan Aladdin, ICTM | Genmab | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Brussels | 1000 | Belgium | |||
| Hospital Erasme |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zalatumumab 8 mg/kg | Participants received zalutumumab 8 milligrams per kilogram (mg/kg) intravenously once weekly in combination with irinotecan 180 milligrams per meter square (mg/m^2) every 2 weeks up to 10 months. |
| FG001 | Zalutumumab 16 mg/kg | Participants received zalutumumab 16 mg/kg intravenously once weekly in combination with irinotecan 180 mg/m^2 every 2 weeks up to 10 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zalatumumab 8 mg/kg | Participants received zalutumumab 8 mg/kg intravenously once weekly in combination with irinotecan 180 mg/m^2 every 2 weeks up to 10 months. |
| BG001 | Zalutumumab 16 mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who had been exposed to zalutumumab or irinotecan, irrespective of their compliance to the planned course of treatment. | Posted | Count of Participants | Participants | From first dose up to follow-up (up to approximately 1 year) |
|
From first dose up to follow-up (up to approximately 1 year)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zalatumumab 8 mg/kg | Participants received zalutumumab 8 mg/kg intravenously once weekly in combination with irinotecan 180 mg/m^2 every 2 weeks up to 10 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease progression | General disorders | CTCAE (3.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva Järlid Westerberg, VP Clinical Operations | Genmab A/S | +45 7020 2728 | E.Westerberg@genmab.com |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C546618 | zalutumumab |
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| Up to 1 year |
| Brussels |
| 1070 |
| Belgium |
| St-Luc University Hospital | Brussels | 1200 | Belgium |
Participants received zalutumumab 16 mg/kg intravenously once weekly in combination with irinotecan 180 mg/m^2 every 2 weeks up to 10 months.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Zalutumumab 16 mg/kg | Participants received zalutumumab 16 mg/kg intravenously once weekly in combination with irinotecan 180 mg/m^2 every 2 weeks up to 10 months. |
|
|
| Secondary | 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. | All participants who had been exposed to zalutumumab or irinotecan, irrespective of their compliance to the planned course of treatment. | Posted | Count of Participants | Participants | Up to 1 year |
|
|
|
| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | Zalutumumab 16 mg/kg | Participants received zalutumumab 16 mg/kg intravenously once weekly in combination with irinotecan 180 mg/m^2 every 2 weeks up to 10 months. | 3 | 6 | 5 | 6 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Colonic obstruction | Gastrointestinal disorders | CTCAE (3.0) |
|
| Bile duct obstruction | Hepatobiliary disorders | CTCAE (3.0) |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
|
| Fatigue | General disorders | CTCAE (3.0) |
|
| Diarrhoea | Gastrointestinal disorders | CTCAE (3.0) |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) |
|
| Disease progression | General disorders | CTCAE (3.0) |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Urinary tract infection | Renal and urinary disorders | CTCAE (3.0) |
|
| Headache | General disorders | CTCAE (3.0) |
|
| Myalgia | General disorders | CTCAE (3.0) |
|
The site and the PI may be required to withhold the publication for up to 90 days. Subject to a reasoned request from the sponsor, the publication may be further delayed for a period up to 6 months from the date of first submission to the sponsor.
The sponsor has the right to require deletion of any trade secret, proprietary, or confidential information supplied by the sponsor to the site or the PI. The sponsor shall not otherwise have the right to censor publications.
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| Stable Disease |
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| Progressive Disease |
|