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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT01481233
Eligibility Criteria:
Inclusion Criteria:
* Castrate resistant prostate cancer
* Failure or intolerance of taxotere or cabazitaxel-based chemotherapy or abiraterone administered for castrate resistant prostate cancer is allowed
* Age \> 18 years and ability to provide informed consent
* ECOG performance status of 0, 1 or 2
* No prior use of colchicine within the last 2 years
* No chemotherapy, hormonal therapy, immunotherapy or radiation therapy within 1 month of day 1, cycle 1
Exclusion Criteria:
* Inability to provide informed consent
* Hypersensitivity to colchicine
* Severe renal, gastrointestinal or hepatic disorders
* Pre-existing blood dyscrasia
* PLT \< 100K, ANC \< 1000
* Serum Cr \> 2 x ULN
* Bilirubin \> 2 ULN
* AST \> 2 x ULN
* Concurrent use of CYP3A4 inhibitors which may increase drug levels and toxicity
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01481233
Study Brief:
Protocol Section:
NCT01481233