A Phase 2 Study of Itraconazole in Castrate-resistant Prostate Cancer Post-chemotherapy
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Stanford University
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Reduction in Serum PSA
Study Overview
Brief Summary
This study evaluates if itraconazole causes a reduction in the serum levels of prostate-specific antigen (PSA) in male subjects with castration-resistant prostate cancer (CRPC).
Detailed Description
Castration-resistant prostate cancer (CRPC) is also known as "androgen-insensitive" or "hormone-refractory" prostate cancer. While numerous therapies impact biochemical response in the setting of CRPC, there remains unmet medical need, largely expressed as the lack of durable response. New therapies that extend survival of patients beyond that provided by chemotherapy are needed.
It is hypothesized that the triazole antifungal drug itraconazole, through its activity as a potent inhibitor of the Hedgehog (Hh) signaling pathway via the Smoothened (Smo) pathway, may provide clinical benefit in the treatment of prostate cancer. The Hh signaling pathway is a critical embryonic developmental pathway whose aberrant activity has been implicated in the growth and metastases of a variety of tumor types including prostate cancer. Itraconazole is structurally related to ketoconazole, demonstrated to reduce serum PSA by more than 50% in about 20 to 25% of treated prostate cancer subjects.
This study will assess efficacy on the basis of serum levels of PSA, an established surrogate endpoint for efficacy in prostate cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Itraconazole
600 mg/day oral (PO)
Intervention: Itraconazole (Drug)
Outcomes
Primary Outcomes
Reduction in Serum PSA
Time Frame: 12 weeks treatment, with primary outcome assessed at 15 weeks
Number of subjects with \> 50% drop in serum PSA as compared to baseline, at 12 weeks and confirmed at 15 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Sandy Srinivas
Associate Professor of Medicine
Stanford University