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Study ID
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7639
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Investigator
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Robert Montgomery, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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Title
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Abiraterone Acetate in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
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Conditions
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Adenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
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Interventions
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Drug: abiraterone acetate
Drug: prednisone
Other: laboratory biomarker analysis
Other: pharmacological study
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Phase
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Phase 2
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Purpose
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This phase II trial studies how well giving abiraterone acetate works in treating patients
with metastatic hormone-resistant prostate cancer. Abiraterone acetate may stop the growth
of tumor cells by blocking some of the enzymes needed for cell growth
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Eligibility
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Ages Eligible: 18 Years
Genders Eligible:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:- Have signed an informed consent document indicating that the subjects understands the
purpose of and procedures required for the study and are willing to participate in
the study
- Written authorization for use and release of health and research study information
has been obtained
- Be willing/able to adhere to the prohibitions and restrictions specified in this
protocol
- Able to swallow the study drug whole as a tablet
- Willing to take abiraterone acetate on an empty stomach; no food should be consumed
at least two hours before and for at least one hour after the dose of abiraterone
acetate is taken
- Patients who have partners of childbearing potential must be willing to use a method
of birth control with adequate barrier protection as determined to be acceptable by
the principal investigator and sponsor during the study and for 1 week after last
dose of abiraterone acetate
- Histologically proven adenocarcinoma of the prostate
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Metastatic castration resistant prostate cancer as defined by serum testosterone < 50
ng/ml and one of the following:
- Prostate specific antigen (PSA) level of at least 2 ng/ml that has risen on at
least 2 successive occasions at least 1 week apart
- Evaluable disease progression by modified RECIST (Response Evaluation Criteria
in Solid Tumors)
- Progression of metastatic bone disease on bone scan with > 2 new lesions
- Maintenance of Lupron or antagonist unless previously treated with orchiectomy
- The presence of metastatic disease amenable to computed tomography (CT) or ultrasound
guided biopsy; this may include thoracolumbar vertebral bodies, pelvis, femur or
humerus, or soft tissue or nodal metastasis amenable to biopsy (excluding lung or
pleural lesions)
- Patients may have received secondary hormonal manipulations (excluding prior
Abiraterone acetate, MDV3100 or TAK700) or up to two cycles of chemotherapy; all
prior therapy except Lupron must have been discontinued for more than 4 weeks before
enrollment
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 1.5 x upper limit
of normal (ULN)
- Total bilirubin =< 1.5 x ULN
- Calculated creatinine clearance >= 60 mL/min
- Platelet count of >= 100,000/uL
- Absolute neutrophil count of > 1,500 cell/mm^3
- Hemoglobin >= 9.0 g/dL
Exclusion Criteria:- Active infection or other medical condition that would make prednisone/prednisolone
(corticosteroid) use contraindicated
- Patients who are currently receiving active therapy for other neoplastic disorders
will not be eligible
- Patients with histologic evidence of small cell carcinoma of the prostate will not be
eligible
- Known brain metastasis
- Uncontrolled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP
>= 95 mmHg); patients with a history of hypertension are allowed provided blood
pressure is controlled by anti-hypertensive treatment
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- Clinically significant heart disease as evidenced by myocardial infarction, or
arterial thrombotic events in the past 6 months, severe or unstable angina, or New
York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction
measurement of < 50 % at baseline
- Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
- Administration of an investigational therapeutic within 30 days of screening
- Patients with dementia/psychiatric illness/social situations that would limit
compliance with study requirements or would prohibit the understanding and/or giving
of informed consent will not be eligible
- Patients with any condition that, in the opinion of the investigator, would
compromise the well-being of the subject or the study or prevent the subject from
meeting or performing study requirements
- Patients unable to stop chronic anticoagulation for 3 days
- Patients with poorly controlled diabetes
- Patients with a history of gastrointestinal disorders (medical disorders or extensive
surgery) that may interfere with the absorption of the study agents
- Patients with a pre-existing condition that warrants long-term corticosteroid use in
excess of study dose
- Patients with known allergies, hypersensitivity, or intolerance to abiraterone
acetate or prednisone or their excipients
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Study Location
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N/A
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Contact
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Robert B. Montgomery
206-598-0860
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Information obtained from ClinicalTrials.gov, on
5/25/2013. For additional information about
this and other clinical trials,
visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier:
NCT01503229
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