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 access to CB7630 for patients who have completed 12 cycles of abiraterone acetate treatment and continue to receive clinical benefit from such a treatment. |
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E.2.2 | Secondary objectives of the trial |
To evaluate safety of abiraterone acetate To evaluate efficacy of abiraterone acetate
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Willing and able to provide written informed consent 2. Written Authorization for Data Protection Consent has been obtained 3. Age ≥ 18 years and male 4. Completed 12 cycles of CB7630 under the main study of COU-AA-001. Last dose of CB7630 is within 14 days prior to study treatment in COU-AA-001-EXT 5. Demonstrating the potential to gain clinical benefit if abiraterone acetate treatment continues. 6. Serum potassium ≥ 3.5 mmol/L 7.Eastern Cooperative Oncology Group (ECOG) Performance Status of < 3. (Karnofsky Performance Status ≥ 30%) (Attachment 13.4) 8. Able to swallow the CB7630 whole as a capsule or tablet 9. Able to follow study instructions, accessible for treatment and follow-up, and likely to complete all study requirements 10. Agree to use effective contraception precautions throughout the study and for 13 weeks after the last dose if sexually active with partners of child bearing potential |
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E.4 | Principal exclusion criteria |
1. Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection 2. Uncontrolled hypertension 3. 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 4. 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 enrollment and after consultation with a cardiologist to insure that the disease is stable. 5. 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) |
Criteria for effectiveness (PSA progression and objective progression) are described below. PSA measurements: PSA measurements will be analyzed by the PSAWG (PCWG1) criteria. PSA measurements will be taken at Day 1, cycle one of study COU-AA-001-EXT or end of study COU-AA-001 and subsequently at time points as indicated in the schedule of visits. Any unscheduled PSA measurement may be utilized in the periodic assessment of PSA progression. Survival: Death data will be collected according to the visit schedule
Adverse events related to study drug will be collected and graded acording to NCI CTCAE v 3.0 |
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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 | Yes |
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 | Yes |
E.7.1.3.1 | Other trial type description |
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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 | No |
E.8.1.2 | Open | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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Duration of the study is until CB7630 becomes available through local healthcare provider(s) or development programs cease to exist. On this basis it is not possible to provide an estimated duration. |
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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 | 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 |