A Phase II Study of BAY 43-9006 in Combination With Bicalutamide in Patients With Chemo-Naïve Hormone Refractory Prostate Cancer
The biologic and clinical activity and tolerability of BAY 43-9006, the therapeutic needs of
the proposed patient population, and the experimental evidence in support of targeting the
VEGF/VEGFR and MAPK pathways in combination with androgen receptor blockade in prostate
cancer, provides a strong rationale for the proposed phase II trial to evaluate the
tolerability and anti-cancer activity of combined treatment with the non-steroidal
anti-androgen bicalutamide with the multi-targeted kinase inhibitor BAY 43-9006 in patients
with prostate cancer that is progressing after castration therapy.
The primary study objective is to define the efficacy (i.e. post treatment decrement in PSA
(PSA response)) of BAY 43-9006 in combination with bicalutamide in patients with chemo-naïve
hormone-refractory prostate cancer.
- To determine the safety and tolerability of BAY 43-9006 given in combination with
bicalutamide in patients with HRPC.
- To determine the time to treatment failure, PSA progression and disease progression in
HRPC patients treated with BAY 43-9006 in combination with bicalutamide.
- To determine objective response rates in HRPC patients with measurable disease treated
with BAY 43-9006 in combination with bicalutamide.
This is a phase II clinical trial in patients with androgen independent prostate cancer
which will evaluate the therapeutic activity and safety profile of BAY 43-9006 given orally
at the recommended phase II dose of 400 mg PO BID continuously in combination with
bicalutamide 50 mg PO daily continuously. Each 4 week period will be considered 1 cycle.
Doses will be adjusted for toxicity.
Primary Endpoint The primary endpoint for this study will be the rate of PSA-response of the
combination for patients with rising PSA post castration therapy.
Secondary endpoints will include time to treatment failure, time to PSA progression,
duration of PSA response, median survival time, 1 year survival rate, objective tumor
response rate and stable disease rate as defined by the RECIST criteria, response duration,
and incidence of toxicities by NCI CTCAE.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
rate of PSA-response
Kim N Chi, MD
British Columbia Cancer Agency
Canada: Health Canada