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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 May 2013 |
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Main ID: |
NCT01424930 |
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Date of registration:
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26/08/2011 |
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Primary sponsor: |
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Public title:
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A Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Patients With Metastatic Castration-Resistant Prostate Cancer
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Scientific title:
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An Open-Label Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Subjects With Metastatic Castration-Resistant Prostate Cancer |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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25 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01424930 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Contacts
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Name:
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Janssen-Ortho, Canada Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen-Ortho Inc., Canada |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adenocarcinoma of the prostate
- Metastatic disease documented by bone, computed tomography (CT) or magnetic resonance
imaging (MRI) scan
- Surgical or medical castration with testosterone less than 50 ng/dL (< 2.0 nM)
- Prostate-specific antigen (PSA) or radiographic progression documented by assessments
specified in study protocol
- Platelets >100,000/µl
- Hemoglobin >=9.0 g/dL
- Liver function tests (LFTs): Serum bilirubin < 1.5 x ULN; AST or ALT < 2.5 x ULN;
Eastern Cooperative Oncology Group (ECOG) status score of <=2
Exclusion Criteria:
- Small cell carcinoma of the prostate
- Known brain metastasis, chronic liver disease with elevated LFTs
- Prior cytotoxic chemotherapy for metastatic prostate cancer
- Treatment of prostate cancer within 30 days of Day 1 Cycle 1 with surgery, radiation,
chemotherapy or immunotherapy
- Use of investigational drug within 30 days of Day 1 Cycle 1 or current enrollment in
an investigational drug or device study
- Recent history of ischemic heart disease, Electrocardiogram (ECG) abnormalities or
atrial fibrillation
- Active infection or other medical condition that would make prednisone
(corticosteroid) use contraindicated
- Chronic medical condition requiring a higher dose of corticosteroid than prednisone 5
mg twice daily
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Prostate Neoplasms
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Intervention(s)
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Drug: Abiraterone acetate and prednisone; high-fat diet
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Drug: Abiraterone acetate and prednisone; low-fat diet
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Primary Outcome(s)
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Hematology and chemistry assessments
[Time Frame: Cycle 1 Day 8 to Cycle 2 Day 1 pre-dose (food safety evaluation period)]
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Physical exams
[Time Frame: Cycle 1 Day 8 to Cycle 2 Day 1 pre-dose (food safety evaluation period)]
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Toxicity related to dosing after low-fat or high-fat meals
[Time Frame: Cycle 1 Day 8 to Cycle 2 Day 1 pre-dose (food safety evaluation period)]
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Vital sign measurements
[Time Frame: Cycle 1 Day 8 to Cycle 2 Day 1 pre-dose (food safety evaluation period)]
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Secondary Outcome(s)
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Plasma levels of study agents
[Time Frame: Cycle 1 Day 7 through Cycle 1 Day 14]
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Secondary ID(s)
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212082PCR2008
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CR018715
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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