Abiraterone Acetate Dose-Escalation Study in Hormone Refractory Prostate Cancer

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activities of abiraterone acetate (also referred to as CB7630) in patients with hormone refractory prostate cancer (HRPC).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Abiraterone Acetate; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Hormones; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

Criteria

Inclusion Criteria:

Phase 1

• Histologically confirmed adenocarcinoma of the prostate

• No prior therapy with chemotherapy for prostate cancer

• Ongoing gonadal androgen deprivation therapy with luteinizing hormone-releasing hormone (LHRH) analogues or orchiectomy

• Testosterone <50 ng/dL

• Progressive disease after androgen deprivation

• The presence of objective metastatic disease is NOT required for study eligibility

• Demonstrate disease progression after antiandrogen withdrawal

• Eastern Cooperative Oncology Group (ECOG) performance status score = 0-1

• Laboratory values within protocol-defined parameters

• Systolic blood pressure <160 mmHg and diastolic blood pressure <110mmHg documented on at least 3 different days

• Baseline adrenocorticotropic hormone (ACTH) stimulation test demonstrating a peak cortisol >18 µg/dL

• Agrees to protocol-defined use of effective contraception

• Life expectancy of >=12 weeks

Phase 2

• Same as Phase 1 criteria with addition of following criteria

• Neoadjuvant or adjuvant chemotherapy is only allowed if the last dose is >1 year from Cycle 1 Day 1

• Target or non-target abnormalities must be present either on screening bone scan, computed tomography or magnetic resonance imaging

• No prior treatment with ketoconazole for the management of androgen independent prostate cancer

Exclusion Criteria:

Phase 1

• Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart) any herbal product known to decrease prostate specific antigen (PSA) levels (eg, saw palmetto and PC-SPES), or any systemic corticosteroid within 4 weeks prior to first dose of study drug

• Initiation of bisphosphonate therapy within 4 weeks prior to first dose of study drug

• Therapy with supplements or complementary medicines/botanicals within 4 weeks of first dose of study drug, except for any combination of the following: conventional multivitamin supplements, selenium, lycopene, soy supplements

• Prior radiation therapy completed <4 weeks prior to enrollment

• Prior chemotherapy for hormone refractory prostate cancer

• Any currently active second malignancy, other than non-melanoma skin cancer

• Systolic blood pressure >=160 mmHg or diastolic blood pressure >=110 mmHg measured on at least 2 occasions

• NYHA Class III or IV congestive heart failure

• Myocardial infarction within the 6 months prior to the first dose of study drug

• Serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled

• Active psychiatric illnesses/social situations that would limit compliance with protocol requirements

• Active or uncontrolled autoimmune disease that may require corticosteroid therapy during study

Phase 2

• Same as phase 1 with the following addition

• Abnormal electrocardiogram, including any finding which would interfere with assessment of intervals (patients with long QT syndrome, bundle branch blocks or hemiblocks are prohibited)