NCT00702923 - CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

September 30, 2011

Study Completion Date

March 31, 2013

Conditions

Prostate Cancer

Interventions

DRUG

Bicalutamide and CP-675,206 (Tremelimumab)

"Dose level -1 :~Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 3 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7)"

DRUG

Bicalutamide, CP-675,206 (tremelimumab)

"Dose level 1:~Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 6 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7)"

DRUG

Bicalutamide, CP-675,206 (Tremelimumab)

"Dose level 2:~Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 10 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7)"

DRUG

Bicalutamide, CP-675,206 (Tremelimumab)

"Dose level 3:~Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 15 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7)"

DRUG

Bicalutamide, CP-675,206

"Final Dose Level:~Bicalutamide 150 mg p.o. q.d. day 1-28, day 85-112~At month 9, if evidence of PSA progression:~Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 (MTD dose) I.V. over 1 hour, day 29"

Trial Locations (1)

53792

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison