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Abiraterone Post Ketoconazole for Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01199146
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Johnson & Johnson
Cougar Biotechnology, Inc.
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Drug: Abiraterone acetate Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : September 10, 2010
Actual Primary Completion Date : January 4, 2013
Actual Study Completion Date : March 14, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Abiraterone acetate Drug: Abiraterone acetate
Abiraterone acetate 1000 mg by mouth per day
Other Name: CB7630

Primary Outcome Measures :
  1. Preliminary Evidence of Efficacy of Abiraterone Acetate [ Time Frame: 12 weeks from beginning of abiraterone treatment ]
    number of patients with ≥ 30% PSA decline after 12 weeks of abiraterone treatment

Secondary Outcome Measures :
  1. Time To Progression (TTP) [ Time Frame: beginning of treatment until disease progression according to Prostate Cancer Working Group 2 (PCWG2) criteria ]
  2. Proportion of Patients With PSA Decline of > 50% [ Time Frame: 12 weeks from beginning of therapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01199146

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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.
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Principal Investigator: Charles J Ryan, MD University of California, San Francisco

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Responsible Party: University of California, San Francisco Identifier: NCT01199146    
Other Study ID Numbers: CC# 085514
First Posted: September 10, 2010    Key Record Dates
Results First Posted: January 8, 2018
Last Update Posted: January 8, 2018
Last Verified: December 2017
Keywords provided by University of California, San Francisco:
Abiraterone acetate
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Abiraterone Acetate
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 CYP3A Inhibitors