NCT00075192CompletedPhase 1
A Phase 1, Open Label, Non-Randomized, Dose Escalation Study to Evaluate the Safety of CP-675,206 in Combination With Neoadjuvant Androgen Ablation and a Phase 2, Open Label, Randomized Study to Evaluate the Efficacy of CP-675,206 in Combination With Neoadjuvant Androgen Ablation and Androgen Ablation Alone in Patients With High Risk Prostate Cancer
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 8
- Locations
- 12
- Primary Endpoint
- Assess safety of combination therapy and effectiveness as assessed by pathological response after 3 months of treatment follow for disease status for a maximum of 24 months
Study Overview
Brief Summary
This is a multi-center, open label, randomized study. Patients will be randomized to one of the following arms with an allocation ratio of 3:1, respectively: Arm A: CP-675,206 + neoadjuvant hormone therapy (NHT) OR Arm B: neoadjuvant hormone therapy. After randomization, patients will receive study treatment for three cycles (one cycle is defined as 28 days). After completion of three cycles, patients will undergo a prostatectomy and pathology assessments will be completed at a central laboratory, the Armed Forces Institute of Pathology (AFIP) in Washington, DC.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed adenocarcinoma of the prostate, previously untreated
- •Potential candidate for radical prostatectomy on the basis of the patient's general medical condition, performance status, and life expectancy
- •Potential candidate for NHT prior to prostatectomy, including high or intermediate risk of recurrence, based on an estimated risk of biochemical recurrence: High risk category: PSA >20 or Gleason score 8 or cT2c/cT3 OR Intermediate risk category: PSA >10 and d20 or Gleason score 7 or cT2b
- •No evidence of metastatic disease by physical examination, bone scan, and computed tomography, or MRI, of the abdomen and pelvis
- •Age > 18 years
- •ECOG performance status 0-1
- •Adequate bone marrow, hepatic, and renal function determined within 2 weeks prior to starting therapy
- •Availability of prostatectomy specimen for histological analysis at the Armed Forces Institute of Pathology
Exclusion Criteria
- •Prior hormone therapy, radiation, chemotherapy, or immunologic therapy for prostate cancer
- •History of, or significant risk for, chronic inflammatory or autoimmune disease
- •Potential requirement for systemic corticosteroids before surgery based on prior history
- •History of autoimmune colitis or chronic GI conditions associated with diarrhea or bleeding, or current acute colitis of any origin
- •Any serious uncontrolled medical disorder or active infection which would impair ability to receive study treatment and subsequent prostatectomy
- •Coexisting malignancies except basal or squamous cell carcinoma of the skin
Outcomes
Primary Outcomes
Assess safety of combination therapy and effectiveness as assessed by pathological response after 3 months of treatment follow for disease status for a maximum of 24 months
Secondary Outcomes
- assess Pk during treatment monitor for human anti-human antibodies at the end of the study explore genetic influences on safety and/or immune response
Investigators
Study Sites (12)
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