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A Phase I/II Open Label Study of the 17a-Hydroxylase/ C17,20 Lyase Inhibitor, Abiraterone Acetate in Patients With Prostate Cancer Who Have Failed Hormone Therapy

Phase 1
18 Years
Not Enrolling
Prostate Neoplasms

Thank you

Trial Information

A Phase I/II Open Label Study of the 17a-Hydroxylase/ C17,20 Lyase Inhibitor, Abiraterone Acetate in Patients With Prostate Cancer Who Have Failed Hormone Therapy

This is an open-label (identity of study drug will be known) study to evaluate the safety,
tolerability, and recommended dose of abiraterone acetate (referred to as abiraterone) taken
orally (by mouth), once daily in patients with hormone refractory prostate cancer (HRPC).
The study will consist of a dose escalation stage (Phase 1) that will be conducted to
determine the maximum tolerated dose (MTD) of abiraterone and an activity evaluation stage
(Phase 2) to evaluate the activity of abiraterone in patients with HRPC. Abiraterone acetate
(also known as CB7630) is a drug that suppresses the synthesis of testosterone. Abiraterone
will be taken orally once daily. Single doses of abiraterone (starting at 250 mg up to a
maximum of 2000 mg) will be taken for 28-day treatment periods to determine the MTD.
Patients will take MTD of abiraterone for up to twelve 28 day cycles (12 months).

Inclusion Criteria:

- Histologically documented adenocarcinoma of the prostate, clinically refractory or
resistant to hormone therapy, as documented by progression following at least one
hormonal therapy, which must include orchiectomy or ongoing treatment with
gonadotropin releasing hormone (GnRH) agonists

- Prostate specific antigen (PSA) evidence for progressive prostate cancer

- Patients who were withdrawn from anti-androgen therapy less than 6 months prior to
inclusion in the study require one PSA higher than the last pre-withdrawal PSA or 2
increases in PSA documented after the post-withdrawal nadir >=4 weeks from treatment
withdrawal if treated with flutamide and >=6 weeks if treated with bicalutamide or

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

- Laboratory values within protocol-defined parameters

- Systolic blood pressure <160 and diastolic blood pressure <100 mmHg documented on at
least 3 different days

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

- Castrate testosterone level <50 ng/dl or <2.00 nmol/L (nmol/L x 28.8 = ng/dL)

- Normal baseline adrenocorticotropic hormone (ACTH) stimulation test (this criteria
will be removed if no evidence of adrenocortical insufficiency is observed in the
dose escalation phase)

- Life expectancy of >=12 weeks

- Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

- Prior cytotoxic chemotherapy for prostate cancer (including estramustine, docetaxel
and mitoxantrone). All other systemic chemotherapy must have been completed at least
2 years prior to enrollment

- Prior therapeutic radionucleotide therapy (except Radium 223) for prostate cancer

- Local therapy including external beam radiotherapy, brachytherapy, cryotherapy, or
high-intensity focused ultrasound to the prostate bed within 4 weeks of start of

- Prior ketoconazole, aminoglutethimide, or treatment with any investigational
anticancer agent, including systemic corticosteroids for the treatment of prostate
cancer, within 4 weeks of start of study

- Patients receiving any other hormonal therapy, including any dose of megestrol
acetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA
levels (eg, saw palmetto and PC-SPES), or any systemic corticosteroid must
discontinue the agent for at least 4 weeks prior to enrollment

- Treatment with any investigational anticancer agent within 4 weeks of start of study.

- Patients on stable doses of bisphosphonates that show subsequent tumour progression
may continue on this medication; however, patients are not allowed to initiate
bisphosphonate therapy within two weeks prior to starting therapy or throughout the

- No supplements or complementary medicines/botanicals are permitted while on protocol
therapy, except for any combination of the following: conventional multivitamin
supplements, selenium, soy supplements

- Patients with serious or uncontrolled co-existent non-malignant diseases, or active
or uncontrolled infection

- Patients with central nervous system disease and/or brain metastases

- No currently active second malignancy other than non-melanoma skin cancer

- Clinical and/or biochemical evidence of hyperaldosteronism

- Patients with well controlled hypertension requiring medication will be allowed after
the dose escalation stage is completed

- NYHA Class III or IV congestive heart failure

- Myocardial infarction within the 6 months prior to start of study

- No active or uncontrolled autoimmune disease that may require corticosteroid therapy
during protocol treatment

- Major surgery or significant traumatic injury within 4 weeks of start of study

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The prostate specific antigen (PSA) response rate

Outcome Time Frame:

Up to Week 24

Safety Issue:


Principal Investigator

Cougar Biotechnology Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Cougar Biotechnology, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

October 2008

Related Keywords:

  • Prostate Neoplasms
  • Prostate neoplasms
  • Hormone refractory prostate cancer
  • Castration resistant prostate cancer
  • Castration refractory prostate cancer
  • Abiraterone acetate
  • CB7630
  • Neoplasms
  • Prostatic Neoplasms