E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hormone refractory prostate cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062904 |
E.1.2 | Term | Hormone-refractory prostate cancer |
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 |
To provide additional treatment of abiraterone acetate (CB7630) to patients who have completed 12 cycles of abiraterone acetate treatment and continue to receive clinical benefit from such treatment. |
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E.2.2 | Secondary objectives of the trial |
To continue to evaluate the safety of abiraterone acetate. To continue to evaluate the efficacy of abiraterone acetate |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Willing and able to provide written informed consent.
Written Authorization for Use and Release of Health and Research Study Information (US) or Data Protection Consent (EU) has been obtained .
Completed 12 cycles of abiraterone acetate under study COU-AA-003.
Last dose of abiraterone acetate is within 14 days of the anticipated commencement of study treatment should the patient meet all other eligibility criteria.
Serum potassium ≥ 3.5 mmol/L.
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 3. (Karnofsky Performance Status ≥ 30%).
Able to swallow the abiraterone acetate capsules whole.
Able to follow study instructions, accessible for treatment and follow-up, and likely to complete all study requirements. |
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E.4 | Principal exclusion criteria |
Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection,
Uncontrolled hypertension.
Abnormal liver function tests consisting of any of the following: Serum bilirubin > 1.5 x ULN ALT > 2.5 x ULN AST > 2.5 x ULN
Clinically significant heart disease as evidenced by a myocardial infarction in the past twelve months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease. Patients with a history of atherosclerotic vascular disease requiring coronary or peripheral artery bypass surgery may be enrolled provided the surgery occurred at least two years prior to enrolment and after consultation with a cardiologist to insure that the disease is stable.
Current enrolment in an investigational drug or device study or participation in such a study within 30 days of Cycle 13 Day 1 other than abiraterone acetate study COU-AA-003.
Patients who have partners of childbearing potential who are not willing to use a method of birth control determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration.
Condition or situation which, in the investigator’s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient’s participation in the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Study treatment will end when patient dies, is lost to follow-up, withdraws informed consent, experiences sustained side-effects, has disease progression or if Cougar Biotechnology decides to terminate development of CB7630. Upon discontinuation from trial, the patient will continue to be followed for overall survival. Overall survival follow-up should be performed every 12 weeks by telephone interview or chart review for up to 3 years.
Disease progression as defined by PSA measurements will be based on a progressively rising PSA according to PSAWG (PCWG1) criteria. Disease progression in soft tissue or bone will be defined by RECIST criteria based on assessments on bone scan, x-ray, CT scan, or MRI or physical examination. |
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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 | Yes |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | Information not present in EudraCT |
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 |
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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
|
Study treatment will end when patient dies, is lost to follow-up, withdraws informed consent, experiences sustained side-effects, has disease progression or if Cougar Biotechnology decides to terminate development of CB7630. Upon discontinuation from trial, the patient will continue to be followed for overall survival. Overall survival follow-up should be performed every 12 weeks by telephone interview or chart review for up to 3 years. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |