Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT00801294
Eligibility Criteria:
Inclusion Criteria:
1. Age over 18 years.
2. Signed informed consent.
3. Histologically proven colorectal adenocarcinoma
4. History or presence of metastatic colorectal cancer (stage IV)
5. Measurable (\>1 cm) or evaluable tumour deposit (according to RECIST criteria)
6. Documented progression or unacceptable toxicity on the last therapy
7. Progression on oxaliplatin-based chemotherapy or unacceptable residual neurotoxicity on oxaliplatin
8. Progression on irinotecan-based chemotherapy or unacceptable toxicity on irinotecan
9. If patients have been previously exposed to Cetuximab or other EGFR inhibitor, they must have shown progression or unacceptable toxicity
10. If patients have been previously exposed to Bevacizumab or other VEGF inhibitor, they must have shown progression or unacceptable toxicity
11. Life expectancy of at least 12 weeks.
12. WHO (ECOG) performance status \<= 2, \<= 1 if age \> 75 years.
13. Adequate hepatic function
14. Adequate renal function
Exclusion Criteria:
1. Prior treatment with small molecule EGFR, HER2 or VEGFR tyrosine kinase inhibitors
2. Treatment with standard chemotherapy or cetuximab within the last 14 days
3. Treatment with bevacizumab within the last 28 days
4. History of other malignancies in the last 5 years, which could affect compliance with the protocol or interpretation of results. Patients with adequately treated basal or squamous cell skin cancer are generally eligible.
5. Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality
6. Significant cardiovascular diseases
7. History of haemorrhagic or thrombotic event in the past 12 months. Known inherited predisposition to bleeds or to thrombosis.
8. Patient with history or clinical or radiological evidence of CNS disease or brain metastases.
9. Pregnancy or breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT00801294
Study Brief:
Protocol Section:
NCT00801294