E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
metastatic Castration Resistant 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 | 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 demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m² (Arm A) or 20 mg/m² (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in patients with metastatic castration resistant prostate cancer (MCRPC) and not previously treated with chemotherapy |
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E.2.2 | Secondary objectives of the trial |
* Evaluate safety in the 3 treatment arms * Compare efficacy of cabazitaxel at 20 mg/m² and 25 mg/m² to docetaxel for: - Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST 1.1), PSA progression, pain progression or death due to any cause - Time to occurrence of any skeletal related events (SRE). * To compare Health-Related Quality of Life (HRQL) * To assess the pharmacokinetic and pharmacogenomics of cabazitaxel- |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Histologically- or cytologically-confirmed prostate adenocarcinoma. 2.Metastatic disease. 3.Progressive disease while receiving hormonal therapy or after surgical castration documented. |
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E.4 | Principal exclusion criteria |
* Prior chemotherapy for prostate cancer, * Less than 28 days elapsed from prior treatment with estramustine, radiotherapy or surgery to the time of randomization. . * Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to > 30% of bone marrow.
* Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.
* Less than 18 years (or country’s legal age of majority if the legal age is > 18 years).
* Eastern Cooperative Oncology Group (ECOG) performance status > 2. leptomeningeal disease.
* Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization. 13.Any severe acute or chronic medical condition which could impair the ability of the patient to participate to the study or interfere with interpretation of study results or patients unable to comply with the study procedures. 14.Absence of signed and dated Institutional Review Board (IRB)-approved patient informed consent form prior to enrollment into the study.
* Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period.
* Inadequate organ and bone marrow function. |
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E.5 End points |
E.5.1 | Primary end point(s) |
OS defined as the time interval from the date of randomization to the date of death due to any cause |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Every 12 weeks until study cut off date |
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E.5.2 | Secondary end point(s) |
- Progression-free survival
- Tumor response in patients with measurable disease (RECIST)
- PSA response
- PSA Progression
- Pain response
- Pain Progression
- Health-Related Quality of Life (HRQL)
- Related skeletal events
- Safety (NCI-CTC version 4.03)
- Pharmacokinetics and pharmcogenomics
- Biomarkers |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
every 12 weeks for radiological assessment
each visit for safety, biology and patient questionnaires |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Collection of circulating free plasma DNA for biomarker studies |
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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 | 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 | No |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
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
| 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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
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 |
Brazil |
Canada |
Israel |
Mexico |
Peru |
Russian Federation |
Taiwan |
Turkey |
European Union |
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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
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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 | 7 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 7 |