E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic Castration-Resistant Prostate Cancer (PCR) |
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E.1.1.1 | Medical condition in easily understood language |
Metastatic Castrate Resistant Prostate Cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036909 |
E.1.2 | Term | Prostate cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this study is to collect additional safety data during treatment with abiraterone acetate plus prednisone among subjects with metastatic CRPC who have failed 1 or 2 chemotherapy regimens, 1 of which contains a taxane base such as docetaxel, who reside in areas in which abiraterone acetate is not yet available through local healthcare providers,and who are not eligible for enrollment into an available ongoing clinical study of abiraterone acetate. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
*Subjects must have signed an informed consent document indicating that they understand 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 (United States [U.S.] sites only) or Data Protection Consent (European sites only) has been obtained.
* Subjects at sites which are participating in the collection of QoL/MRU data will be asked to provide written informed consent for the collection of these personal data.
* Age ≥18 years and male
* Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
* Received at least one but not more than two cytotoxic chemotherapy regimens for metastatic CRPC. At least one regimen must have contained a taxane such as docetaxel. Treatments containing any taxane with or without additional cytotoxic chemotherapeutics given concurrently, (eg, docetaxel carboplatin) are considered a
single prior cytotoxic in the context of eligibility for this study. If a specific taxane is administered more than once (such as when a subject requires a treatment break to resolve toxicity), the entire period of administration of this taxane is considered a single regimen (eg, a subject who received 6 cycles of docetaxel from May to June, followed by a treatment break and then 4 additional cycles of docetaxel from August
to September, would be considered to have received one prior cytotoxic regimen).
* Prostate cancer progression as assessed by the investigator with one of the following:
– PSA progression according to Prostate Cancer Working Group 2 (PCWG2)
criteria
– Radiographic progression in soft tissue according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria or bone scans with or without PSA progression.
* Ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
* Hemoglobin ≥9.0 g/dL independent of transfusion
* Platelet count ≥100,000/μL
* Serum albumin ≥3.0 g/dL
* Serum creatinine <1.5 x upper limit of normal (ULN) or a calculated creatinine clearance ≥ 60 mL/min
* Serum potassium ≥3.5 mmol/L
* Able to swallow the study drug whole as a tablet |
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E.4 | Principal exclusion criteria |
* Eligible for another study of abiraterone acetate that is open to enrollment. Medical monitor review will be required to allow enrollment on this study if a subject is eligible for another abiraterone acetate open study
* Received abiraterone acetate in the past or was enrolled in Studies COU-AA-301 or COU-AA-302.
* Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
* Abnormal liver functions consisting of any of the following:
– Serum bilirubin ≥1.5 x ULN (except for subjects with documented Gilbert’s disease, for whom the upper limit of serum bilirubin is 3 mg/dL)
– Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 x ULN
* Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥95 mmHg); subjects with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy.
* 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 III or IV heart disease or left ventricular ejection fraction (LVEF) of <50% at baseline
* Known brain metastasis
* History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study drug
* Any acute toxicities due to prior chemotherapy or radiotherapy that have not resolved to a NCI-CTCAE Grade of ≤1. Chemotherapy induced alopecia and Grade 2 peripheral neuropathy is allowed
*Use of other anticancer therapy including cytotoxic, radionucleotide, and
immunotherapy; diethylstilbestrol; PC-SPES; spironolactone (ie, ALDACTONE,
SPIRONOL); and other preparations such as saw palmetto thought to have endocrine effects on prostate cancer, within 4 weeks of Cycle 1 Day 1
* Prior systemic treatment with an azole drug (eg. fluconazole, itraconazole, ketoconazole) within 4 weeks of Cycle 1, Day 1
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Day 1
* Condition or situation which, in the investigator's opinion, may put the subjects at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
* Subjects who have partners of childbearing potential who are not 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 13 weeks after last study drug administration
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this study is adverse events that occur during treatment and within 30 days after discontinuation of treatment. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Signing of ICF through 30 days after treatment discontinuation. |
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E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
to provide early access to abiraterone acetate |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 84 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Brazil |
Colombia |
Croatia |
Czech Republic |
Greece |
Hong Kong |
Hungary |
India |
Indonesia |
Italy |
Korea, Republic of |
Lithuania |
Malaysia |
Mexico |
New Zealand |
Philippines |
Poland |
Romania |
Russian Federation |
Singapore |
Spain |
Taiwan |
Thailand |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The study is considered completed with the last assessment of the last subject participating in the study. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |