A Phase II Study of AT101, to Abrogate BCL-2 Mediated Resistance to Androgen Ablation Therapy in Patients With Newly Diagnosed Stage D2 Prostate Cancer
I. To determine the percentage of patients with newly diagnosed metastatic prostate cancer
who demonstrate undetectable prostate-specific antigen (PSA) (< 0.2 ng/mL) at 7 months when
treated with R-(-)-gossypol (AT-101) and androgen ablation therapy.
I. To determine the safety of this regimen in these patients. II. To determine the
percentage of patients with PSA >= 4.0 ng/mL, overall PSA < 4.0 ng/mL, and a PSA >= 0.2
ng/mL but < 4.0 ng/mL during the first 7 months of therapy.
III. To determine changes in Bcl-2 and Bax/Bak protein expression in peripheral blood
mononuclear cells after treatment.
IV. To analyze Bcl-2 family protein expression in baseline tumor tissue.
Patients receive R-(-)-gossypol orally (PO) once daily (QD) on days 1-21. Treatment repeats
every 28 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
Patients may receive bicalutamide PO QD beginning 6 weeks before the initiation of
R-(-)-gossypol and continuing after completion of treatment, at the discretion of the
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of patients with undetectable prostate-specific antigen (PSA) (< 0.2 ng/mL)
At 7 months
Cancer Institute of New Jersey
United States: Food and Drug Administration
|Cancer Institute of New Jersey||New Brunswick, New Jersey 08901|
|University of Wisconsin Hospital and Clinics||Madison, Wisconsin 53792-0001|