E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Male patients with metastatic castration resistant prostate cancer |
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E.1.1.1 | Medical condition in easily understood language |
Male patients with progressive disease on hormonal treatment where next line of treatment is chemotherapy |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10076506 |
E.1.2 | Term | Castration-resistant prostate cancer |
E.1.2 | System Organ Class | 100000004864 |
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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 |
Examine the combination of docetaxel and ebastine in the treatment of castration resistant prostate cancer. |
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E.2.2 | Secondary objectives of the trial |
Examine efficacy of combination of docetaxel and ebastine compared to docetaxel alone |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to participate in this study, the subjects must meet all of the following inclusion criteria: 1. Have a histologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate (carcinomas with pure small-cell histology or pure high grade neuroendocrine histology are excluded; neuroendocrine differentiation is allowed). 2. Surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL equivalent to 1.7 nmol/L. For patients, currently being treated with luteinizing hormone–releasing hormone (LHRH) agonists, i.e., patients who have not undergone an orchiectomy, therapy must be continued throughout the study. 3. Have evidence of disease progression after prior therapy for mCRPC: Disease progression after initiation of most recent therapy is based on any of the following criteria: •Rise in PSA: a minimum of 2 consecutive rising levels, with an interval of ≥ 1 week between each determination. The most recent screening measurement must have been ≥ 2 ng/mL •Transaxial imaging: new or progressive soft tissue masses on CT or MRI scans as defined by RECIST 1.1 •Radionuclide bone scan: at least 2 new metastatic lesions 4. Signed informed consent obtained prior to initiation of any study-specific procedures or treatment 5. Age ≥ 18 years 6. Life expectancy ≥ 3 months 7. Performance status 0 - 1 8. Adequate organ functions a. Hematological: absolute neutrophil count (ANC) >1.5 x 109/L, platelet count >100 x 109/L, hemoglobin > 6,2 mmol/L b. Hepatic: Bilirubin within normal range, aspartate transaminase (AST) and alanine transaminase (ALT) <2.5 UNL, albumin > 25 g/L c. Renal: creatinine clearance >30 mL/min/1.73m2
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E.4 | Principal exclusion criteria |
In order to participate in the study subjects must not meet any of the following exclusion criteria: 1. History of significant gastric or small bowel resection, malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may prevent compliance with oral drug administration 2. Presence of any serious concomitant systemic disorders and/or psychiatric condition incompatible with the study (at the investigator’s discretion) 3. Presence of any active infection (at the investigator’s discretion). 4. CNS disease including epilepsy or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures. 5. Concurrent use of cationic amphiphilic drugs (see appendix B) including over-the-counter medication. 6. Use of other investigational drug 7. Allergic reaction to any of the included drugs
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in urine biomarkers; Bis(monoacylglycero)phosphate (BMP) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After each treatment a urine sample will be gathered and evaluated |
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E.5.2 | Secondary end point(s) |
• PSA response rate (≥ 50% decline in PSA compared to baseline according to PCWG3.) • Radiologic progression free survival (rPFS). • Time to PSA progression defined in accordance with PCWG3. • Toxicity in the combination of docetaxel and ebastine.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Response rate is evaluated at time of PSA nadir. Radiologic progression free survival at time of radiologic evaluation. Time to PSA progression at time of PSA progression (PSA is measured once every treatment) |
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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 | No |
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 | 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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
Standard of treatment (docetaxel) |
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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
| 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 | 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
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The end of the study is defined as the last visit of the last subject included in the study. Within 90 days of the end of the study, the Sponsor/GCP unit will notify Competent Authorities and Ethics Committees the regular termination of the of the study as required according to national law and regulations. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |