UCSF Helen Diller Family Comprehensive Cancer Center
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Protocol No.12554Principal InvestigatorRyan, Charles
PhaseI/II (Cancer Control)
Age GroupAdultScopeNational
Secondary Protocol No.TCD12128
TitleA Phase 1/2 Study of Cabazitaxel Combined with Abiraterone Acetate and Prednisone in Patients with Metastatic Castrate-Resistant Prostate Cancer (mCRPC) whose Disease has Progressed after Docetaxel Chemotherapy STUDY NUMBER: TCD12128)
ObjectivePRIMARY • Phase 1 part: To determine the MTD, and DLTs of CBZ administered as a 1-hour infusion every 3 weeks in combination with oral daily ABIa and prednisone in patients with mCRPC • Phase 2 part: To estimate the activity of CBZ in combination with ABIa and prednisone in terms of PSA Response Rate.
Key Eligibility* Diagnosis of prostate adenocarcinoma proven histologically or cytologically, resistant to hormone therapy and previously treated with a docetaxel-containing regimen * Presence of metastatic prostate cancer * Progressive disease
Applicable Disease SitesProstate
Therapies InvolvedChemotherapy multiple agents systemic
Drugs InvolvedAbiraterone (Abiraterone Acetate)
Abiraterone Acetate
CB7630 (Abiraterone Acetate)
Jevtana (Cabazitaxel)
XRP6258 (Cabazitaxel)
Zytiga (Abiraterone Acetate)
Participating InstitutionsMt. Zion : Kathryn Koepfgen
Eligibility Document12554_CTGovEligibility_NCT01511536.doc
ContactKathryn Koepfgen Phone: