Refractory Colorectal Cancer MedDRA version: 9.1 Level: LLT Classification code 10061451 Term: Colorectal cancer
Conditions
Sponsors
Genmab A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and Females age = 18 years. 2. Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out. 3. Histologically or cytologically confirmed diagnosis of CRC. 4. Documented disease progression (verified by CT scan and/or MRI according to RECIST) during or within 6 months of finishing cetuximab-based therapy • These images can be used as baseline for this protocol provided they were taken no more than 3 weeks prior to randomization 5. The cumulative dose of cetuximab must be = 1000mg/m2 6. Failure and/or intolerance to standard chemotherapy 7. Measurable disease defined as one or more target lesions according to RECIST. 8. WHO performance status = 2. 9. Absence of KRAS mutation in the tumor specimen. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior treatment with anti-EGFR antibodies other than cetuximab 2. Received the following treatments within 4 weeks prior to Visit 2: - Cytotoxic or cytostatic anti-cancer chemotherapy - Total resection or irradiation of the target lesion - Any investigational agent 3. Diarrhea CTCAE > 1 4. Skin rash CTCAE > 1 5. Intolerance to irinotecan 6. Past or current malignancy other than CRC, except for: - Cervical carcinoma Stage 1B or less - Non-invasive basal cell and squamous cell skin carcinoma - Malignant melanoma with a complete response of a duration of > 10 years - Other cancer diagnoses considered in remission for > 5 years 7. Chronic or current infectious disease 8. Known brain metastasis or leptomeningeal disease. 9. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities 10. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease evaluated by the investigator interfere with effect of the study drug 11. Expected survival 5 times the upper limit of normal - ALP > 5 times the upper limit of normal (unless known bone metastases) - Bilirubin > 1.5 times the upper limit of normal - Creatinine > 1.5 the upper limit of normal. 15. Current participation in any other interventional clinical study 16. Patients known or suspected of not being able to comply with this trial protocol 17. Breast feeding women or women with a positive pregnancy test at Visit 1. 18. Male not willing to use adequate contraception during and 12 months after last dose of zalutumumab or women of childbearing potential not willing to use adequate contraception as hormonal birth control or intrauterine device, during study and 12 months after last dose of zalutumumab. 19. Patients with known uncontrolled allergic conditions or allergy to the study drugs and/or their components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective Part 1 • Evaluate the safety of escalating dose of zalutumumab in combination with irinotecan in patients with colorectal cancer (CRC) who have failed previous standard chemotherapy and who have progressed during or within 6 months of stopping treatment with cetuximab. Part 2 • To investigate the efficacy of zalutumumab administered alone or in combination with irinotecan in patients with CRC who have failed previous standard chemotherapy and who have progressed during or within 6 months of stopping treatment with cetuximab.;Secondary Objective: Secondary Objective • To determine the pharmacokinetic profile of zalutumumab administered alone or in combination with irinotecan • To evaluate potential biomarkers. ;Primary end point(s): Part 1 • Adverse events, clinical laboratory tests and vital signs Part 2 • Objective Response Rate, defined as complete or partial response according to best overall response (verified by imaging technique and according to RECIST criteria). | — |
Countries
Belgium
Outcome results
None listed