Abiraterone Post Ketoconazole for Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Johnson & Johnson
Cougar Biotechnology, Inc.
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01199146
First received: September 9, 2010
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

This is a phase II, open label, single center study to evaluate the efficacy of abiraterone acetate (CB7630) administered to patients with castrate resistant prostate cancer who have experienced disease progression on ketoconazole.

It is hypothesized that abiraterone will be active in patients who have experienced disease progression on ketoconazole


Condition Intervention Phase
Prostate Cancer
Drug: Abiraterone acetate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer (CRPC) and Prior Therapy With Ketoconazole

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • To assess preliminary evidence of efficacy of abiraterone acetate in patients who demonstrate evidence of disease progression on ketoconazole [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: September 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abiraterone acetate Drug: Abiraterone acetate
Abiraterone acetate 1000 mg by mouth per day
Other Name: CB7630

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Prior therapy with ketoconazole for castration resistant prostate cancer. Patients should demonstrate evidence of progression (see below definitions) on ketoconazole or evidence of grades 3/4 toxicities on ketoconazole.

    1. Ketoconazole must have been administered for >28 days
    2. At least 27 days must elapse since last ketoconazole dose and first dose of abiraterone acetate
  • No prior therapy with chemotherapy for metastatic prostate cancer
  • Metastatic disease based on a positive bone scan or objective imaging on CT scan
  • Ongoing gonadal androgen deprivation therapy with LHRH analogues or orchiectomy. Patients, who have not had an orchiectomy, must be maintained on effective LHRH analogue therapy for the duration of the trial
  • Testosterone < 50 ng/dL
  • Progressive disease after androgen deprivation: PSA evidence for progressive prostate cancer consists of a PSA level of at least 2 ng/ml which has risen on at least 2 successive occasions, at least 2 weeks apart
  • Patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen
  • ECOG Performance Status 0-1
  • Age >18 years and able to comply with protocol requirements
  • Serum Creatinine ≤1.5 x ULN
  • Serum potassium >3.5mmol/L
  • Bilirubin ≤1.5x ULN
  • AST and ALT ≤2.5 x ULN
  • Life expectancy of >12 weeks

Exclusion Criteria:

  • Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart) any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid 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 and Soy supplements
  • Prior radiation therapy completed < 4 weeks prior to enrollment
  • Prior chemotherapy for castration resistant prostate cancer. Patients who have received chemotherapy for early stage prostate cancer (e.g. as part of a neoadjuvant or adjuvant trial) or for other malignancies are eligible provided that >1 year has passed since the administration of the last chemotherapy dose.
  • Hemoglobin ≤9.0 g/dL
  • Any "currently active" second malignancy, other than non-melanoma skin cancer Patients are not considered to have a "currently active" malignancy, if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse over next 3 months
  • Blood pressure that is not controlled despite >2 oral agents (SBP >160 and DBP >90 on three or more readings within the screening period)
  • Serum K+ <3.5 mmoL/L on more than one reading within the screening period
  • NYHA Class II, 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
  • Concurrent therapy with drugs that are metabolized as substrates of CYP1A2, CYP2D6, or CYP2C19 and are considered by the investigators to pose a risk for drug to drug interactions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199146

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of California, San Francisco
Johnson & Johnson
Cougar Biotechnology, Inc.
Investigators
Principal Investigator: Charles J Ryan, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01199146     History of Changes
Other Study ID Numbers: CC# 085514
Study First Received: September 9, 2010
Last Updated: August 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
Abiraterone acetate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Ketoconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014