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 @ 10:17 PM
Ignite Modification Date:
2025-12-24 @ 10:17 PM
NCT ID:
NCT00479635
Eligibility Criteria:
Inclusion Criteria:
* Histological or cytological evidence of adenocarcinoma of the prostate and have metastatic disease.
* Patients must have received only one prior regimen for their advanced disease. This regimen must have included a taxane.
* First Stratum Eligibility: Patients must have advanced, metastatic prostate cancer with documented progression after receiving more than three months of treatment, up to a total of 10 months with 1 prior taxane regimen. Prior best response to treatment, and duration of response, will be recorded.
* Second Stratum Eligibility: Patients must have advanced, metastatic prostate cancer that has progressed as best response despite three months or less of treatment with 1 prior taxane regimen.
* Must have castrate levels of testosterone less than 50 ng/mL
* Must have an ECOG Performance Score of 0 or 1
* Must be age 18 or older
* Must be able to read, understand and sign informed consent
* Serum creatinine less than or equal to 2.0 mg/dL
* Total bilirubin less than or equal to 2.0 mg/dL
* SGOT/SGPT less than or equal to 3 times the ULN
* ANC greater than or equal to 1500/UL
* Platelet count greater than or equal to 100,000/UL Recovered from the effects of prior surgery, radiotherapy or other antineoplastic therapy.
Exclusion Criteria:
* Active infection or with a fever greater than or equal to 38.5 degrees centigrade within 3 days of first scheduled day of dosing
* More than one prior systemic therapy for HRPC beyond androgen-ablative therapy. Prior systemic therapy may have been administered for metastatic disease or as adjuvant therapy
* Has received radiotherapy to greater than 30% of their active bone marrow
* History of prior malignancy within the past 5 years except for curatively treated non-melanoma skin cancer
* Impending fracture of a weight bearing bone
* Known hypersensitivity to any of the components of TPI 287
* Receiving concurrent investigational therapy or who have received investigational therapy within 30 days of study start
* Grade 2 peripheral neuropathy
* NYHA Class 3 or 4 congestive heart failure
* Any medial condition that would interfere with ability to sign ICF, cooperate and participate in the study or interfere with interpretation of results
* History of allogenic transplant
* Know HIV or Hepatitis B or C positive
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00479635
Study Brief:
Protocol Section:
NCT00479635