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)
Cabazitaxel
Jevtana (Cabazitaxel)
XRP6258 (Cabazitaxel)
Zytiga (Abiraterone Acetate)
StatusOpen
Participating InstitutionsMt. Zion : Kathryn Koepfgen
Eligibility Document12554_CTGovEligibility_NCT01511536.doc
ContactKathryn Koepfgen Phone:
Pager:
Email:kkoepfgen@medicine.ucsf.edu