E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This study is designed to evaluate the safety of biweekly cabazitaxel for the treatment of metastatic castration resistant prostate cancer (mCRPC) previously treated with docetaxel containing regimen. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 evaluate safety of cabazitaxel administered every second week (biweekly) |
|
E.2.2 | Secondary objectives of the trial |
To evaluate:
- Time to treatment failure
- Response rate
- Overall survival
- Quality of life |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Metastatic castration resistant prostate cancer
- Disease progression during or after docetaxel-containing regimen for mCRPC
- Surgical or medical castration
- WHO performance status < or = 2
- Age > 18 years
- Adequate bone marrow, liver and renal functions:
Hematology:
- neutrophils > 1.5 x 109/ l
- hemoglobin > 100 g/l
- platelets > 100 x 109/l
Hepatic function:
- total bilirubin < or = 1 x UNL
- ALAT and ASAT < 2.5 x UNL, Alkaline Phosphate < or = 6 x UNL. In the presence of extensive bone disease, alkaline phosphate > 6 x UNL is accepted
Renal function:
-Creatinine < 1.5 x UNL (ie NCI grade < 1) |
|
E.4 | Principal exclusion criteria |
- Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment
- Prior therapy with radioisotopes
- Other malignant disease/ malignancy (except superficial non-melanoma skin cancer) within the past 5 years
- Serious liver disease
- History of severe hypersensitivity reaction (grade > 3) to polysorbate 80 containing drugs
- Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who already are on these treatments)
- Other serious illness or medical condition:
(a) Serious cardiac disease; ischemic or thromboembolic cardiac disease, pulmonary
emboli, cardiac infarction within 12 months
(b) Active infection
(c) Active peptic ulcer, uncontrolled diabetes mellitus or other contraindications for the use
of corticosteroids
(d) Auto-immune disease (lupus, scleroderma, rheumatoid polyarthritis)
(e) Active grade > 2 polyneuropathy |
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
will be measured by using CTC-AE Version 4.0 common toxicity criteria every second week
laboratory values every week |
|
E.5.2 | Secondary end point(s) |
Time to treatment failure
- progression in PSA
- progression of evaluable or measurable metastases
- unacceptable toxicity
- patients´ refusal to continue treatment
- death
Response rate
Quality of life (QoL)
Overall survival |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
PSA and QoL every 6th week and tumour evaluation every 12th week |
|
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 | 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) | 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
| 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 | 5 |
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 | No |
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
|
The end of the trial is the date of the final scheduled visit for the last patient to complete the study |
|
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 | 3 |
E.8.9.1 | In the Member State concerned days | 0 |