Finding studies
Finding studies
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Lead
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
With
PRIMARY OBJECTIVES: 1. Phase I: To determine the safe dose of alisertib when given in combination with abiraterone (abiraterone acetate) and prednisone in metastatic castration resistant prostate cancer (mCRPC) patients with disease progression on abiraterone and prednisone. 2. Phase II: To determine the proportion of patients who have no disease progression after alisertib is added to abiraterone and prednisone. SECONDARY OBJECTIVES: 1. Phase II: To determine the prostate specific antigen (PSA) kinetics after alisertib is added to abiraterone and prednisone regimen (this includes the proportion of patients with PSA progression free at 3 months, proportion of patients with 50% PSA reduction after study treatment, maximum PSA decline from baseline during the first 12 weeks). 2. Phase II: To compare baseline circulating tumor cells (CTCs) enumeration to 12 week post-therapy CTC enumeration. 3. Phase II: To compare baseline neuroendocrine marker (chromogranin A and neuron-specific enolase \[NSE\]) levels to 12 week post therapy neuroendocrine marker levels. 4. Phase II: To further assess overall safety of combination of alisertib with abiraterone and prednisone in the phase 1 portion of the study. OUTLINE: This is a phase I, dose escalation study of alisertib followed by a phase II study. Patients receive alisertib orally (PO) twice daily (BID) on days 1-7, abiraterone acetate PO daily, and prednisone PO BID. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
