A Phase II Trial of TPI 287 in Patients With Metastatic Prostate Cancer

• Status: Terminated
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objective of the study is to determine the response rate to TPI 287 in patients with metastatic, hormone-refractory prostate cancer who have had one prior taxane regimen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cortice Biosciences, Inc.

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