E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy |
|
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 | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060862 |
E.1.2 | Term | 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 determine the benefit of MDV3100 as compared to placebo as assessed by overall survival. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Progressive prostate cancer;
-One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel;
-Medical or surgical castration with a testosterone level < 1.7 nmol/L (50 ng/dL);
-ECOG performance status of 0-2;
-Adequate bone marrow, hepatic, and renal function;
-Able to swallow the study drug and comply with study requirements;
-Willing and able to give informed consent.
Open-Label Extension Criteria for Patients Randomized to the Placebo
Arm Patients randomized to the placebo arm of the blinded portion of
the study must meet the following inclusion criteria:
-Willing and able to give informed consent;
-No more than a total of two prior chemotherapy regimens;
-ECOG performance status of 0–2;
-Able to swallow the study drug and comply with study requirements;
Open-Label Extension Eligibility Criteria for Patients Continuing
MDV3100 Patients continuing MDV3100 must meet the following
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eligibility criterion:
-Willing and able to give informed consent for open-label extension
period. |
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E.4 | Principal exclusion criteria |
-Metastases in the brain or active epidural disease;
-Another malignancy within the previous 5 years;
-Clinically significant cardiovascular disease;
-Gastrointestinal disorder affecting absorption.
Open-Label Extension Criteria for Patients Randomized to the Placebo
Arm
Patients randomized to the placebo arm of the blinded portion of the
study must NOT meet any of the following exclusion criteria:
-Known or suspected brain metastasis;
-Clinically significant cardiovascular disease including |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy outcome is a comparison of overall survival between the MDV3100-treated and the placebo groups. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
When the required number of deaths have occurred as specified in the protocol. |
|
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 | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
English The study will be unblinded and patients randomized to placebo will be offered to receive MD |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 68 |
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 |
Argentina |
Australia |
Austria |
Belgium |
Canada |
Chile |
France |
Germany |
Italy |
Netherlands |
Poland |
South Africa |
United Kingdom |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
All patients MUST be followed for survival until death, by means of a telephone contact every 12 weeks following their last study visit to confirm that the patients are alive and to document if they have received any additional antineoplastic therapy for their prostate cancer, and if they have had a skeletal-related event. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |