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:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-24 @ 6:52 PM
NCT ID:
NCT01412957
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of metastatic colorectal cancer (CRC)
* Wild-type (without mutation in codons 12 and 13) KRAS gene in tumor tissue confirmed by a central laboratory
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* At least 1 measurable or non-measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
* Treatment failure (defined as failure due to either disease progression \[clinical or radiological\] or toxicity \[treatment intolerance\]) of a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease. Oxaliplatin and irinotecan may have been administered sequentially or in combination.
* Disease relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease
* Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of CRC
* Man or woman at least 18 years of age
* Adequate hematologic, renal, hepatic and metabolic function
* Negative pregnancy test within 72 hours before randomization (for women of childbearing potential only)
* Subject or subject's legally acceptable representative has provided informed consent.
* Other protocol-specified criteria may apply
Exclusion Criteria:
* Symptomatic brain metastases requiring treatment
* History of another primary cancer within 5 years of randomization
* Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFR inhibitors (eg, gefitinib, erlotinib, lapatinib)
* Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) within 21 days before randomization
* Radiotherapy within 14 days before randomization.
* Exclusion Criteria for corrected QT (QTc) Evaluation Subpart of the Study: Prolongation of QT/QTc interval \> 450 milliseconds at screening
* Other protocol-specified criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01412957
Study Brief:
Protocol Section:
NCT01412957