Colorectal Cancer
Conditions
Keywords
Colorectal Neoplasms, Colorectal Tumors, Colorectal Carcinoma
Brief 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
Interventions
DRUGZalutumumab
Solution for infusion
Sponsors
Genmab
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and Females age ≥ 18 years 2. Confirmed diagnosis of CRC 3. Documented disease progression 4. Failure and/or intolerance to standard chemotherapy
Exclusion criteria
1. Prior treatment with anti-EGFR antibodies other than cetuximab 2. Expected survival \< 3 months 3. Clinical significant cardiac disease and/or uncontrolled medical conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Best Overall Tumour Response (BOR) | Up to 1 year | 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. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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. | 6 |
| Total | 9 |
Baseline characteristics
| Characteristic | Zalutumumab 16 mg/kg | Zalatumumab 8 mg/kg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 2 Participants | 7 Participants |
| Age, Continuous | 61 years | 61 years | 61 years |
| Region of Enrollment Belgium | 6 participants | 3 participants | 9 participants |
| Sex: Female, Male Female | 5 Participants | 1 Participants | 6 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 3 | 5 / 6 |
| serious Total, serious adverse events | 2 / 3 | 3 / 6 |
Outcome results
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.
Time frame: From first dose up to follow-up (up to approximately 1 year)
Population: All participants who had been exposed to zalutumumab or irinotecan, irrespective of their compliance to the planned course of treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zalatumumab 8 mg/kg | Number of Participants With Adverse Events (AEs) | 3 Participants |
| Zalutumumab 16 mg/kg | Number of Participants With Adverse Events (AEs) | 5 Participants |
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.
Time frame: Up to 1 year
Population: All participants who had been exposed to zalutumumab or irinotecan, irrespective of their compliance to the planned course of treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zalatumumab 8 mg/kg | Number of Participants With Best Overall Tumour Response (BOR) | Stable Disease | 3 Participants |
| Zalatumumab 8 mg/kg | Number of Participants With Best Overall Tumour Response (BOR) | Complete Response | 0 Participants |
| Zalatumumab 8 mg/kg | Number of Participants With Best Overall Tumour Response (BOR) | Progressive Disease | 0 Participants |
| Zalatumumab 8 mg/kg | Number of Participants With Best Overall Tumour Response (BOR) | Partial Response | 0 Participants |
| Zalutumumab 16 mg/kg | Number of Participants With Best Overall Tumour Response (BOR) | Progressive Disease | 2 Participants |
| Zalutumumab 16 mg/kg | Number of Participants With Best Overall Tumour Response (BOR) | Partial Response | 0 Participants |
| Zalutumumab 16 mg/kg | Number of Participants With Best Overall Tumour Response (BOR) | Stable Disease | 4 Participants |
| Zalutumumab 16 mg/kg | Number of Participants With Best Overall Tumour Response (BOR) | Complete Response | 0 Participants |