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

Stopped early · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00479635

Run by

Cortice Biosciences, Inc.

People needed

26

Starts

2007-01-01

Expected to finish

2008-08-01

Last updated by the study team

2014-01-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Comprehensive Cancer Center at Desert Mountain — Palm Springs, California, United States
• University of Kentucky — Lexington, Kentucky, United States
• Kansas City Cancer Center South — Kansas City, Missouri, United States
• St. Barnabas Medical Center — Livingston, New Jersey, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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