Study Evaluating EKB-569 in Advanced Colorectal Cancer
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This non-randomized, open-label, outpatient clinical trial is designed to assess the safety and efficacy of daily orally administered EKB-569 in subjects with advanced colorectal cancer. Patients must have been previously treated with a fluoropyrimidine (5-FU or capecitabine) and either oxaliplatin or irinotecan (given concurrently or as separate regimens).
The primary objective of the study is to assess the clinical activity of EKB-569 administered orally as a second-line or later stage treatment in subjects with advanced colorectal cancer.
Secondary objectives include:
- To further evaluate the safety of EKB-569
- To explore additional clinical activity parameters
- To explore subject survival
- To evaluate the pharmacokinetics of EKB-569
- To assess subject reported outcomes
EKB-569 will be administered orally as a single-agent. Eligible subjects will take EKB-569 daily as long as they do not have progressive disease and are tolerating treatment.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Signed and dated, institutional review board (IRB) or independent ethics committee (IEC)-approved informed consent form before any protocol-specific screening procedures
- Previous histologic diagnosis of adenocarcinoma of the colon or rectum
- EGFR expression by immunohistochemical analysis (must be > or = 20% positive tumor cells in prior tumor biopsy specimens)
Exclusion criteria
- Chemotherapy, radiotherapy, anticancer immunotherapy, or investigational agents within 4 weeks of treatment day 1 (6 weeks if the previous regimen included mitomycin or nitrosoureas).
- Prior epidermal growth factor receptor-targeting therapy
- Known central nervous system (CNS) metastases
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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