E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Exposure and toxicity of docetaxel treatment with patients with breast or metastatic castration-resistant prostate carcinoma. |
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E.1.1.1 | Medical condition in easily understood language |
Exposure and toxicity of docetaxel treatment with patients with breast or metastatic castration-resistant prostate carcinoma. |
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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 | 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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006187 |
E.1.2 | Term | Breast 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 which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC) for both males and females. |
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E.2.2 | Secondary objectives of the trial |
To determine if occurrence of docetaxel toxicity can be related to dose/Lean body mass.
To determine which methods to measure Lean body mass: DEXA, Bioelectrical Impedance As-sessment (BIA) or formula estimates are accurate enough to be used for dosing drugs.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject is at least 18
2. Subject is able and willing to sign the Informed Consent Form prior to screen-ing evaluations
3. Subject has been diagnosed with either breast or metastatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol
4. Subject has an live expectancy of 12 weeks or greater
5. Absolute neutrophile count (ANC) > 1.5 x 109/L
6. Platelet count > 100 x 109/L
7. Serum creatinine ≤ 2 x ULN
8. Total bilirubin level < 1.5 x ULN
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E.4 | Principal exclusion criteria |
1. Moderate or severe liver impairment; [ALAT and/or ASAT ≥ 1.5 ULN] and [AF ≥ 2.5 ULN]
2. Current therapy with any drug, dietary supplements, or other compounds, or have been used in the last 2 weeks prior to the docetaxel administration, known to inhibit or induce CYP3A4 as mentioned on the list in appendix A.
4. Inability to understand the nature and extent of the study and the procedures required
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E.5 End points |
E.5.1 | Primary end point(s) |
Correlation between Lean Body Mass, total body weight, body surface area and exposure of docetaxel (AUC). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day one, first administration. |
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E.5.2 | Secondary end point(s) |
Correlation between dose/lean body mass and toxicitiy of docetaxel after first administration. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Until the next docetaxel administration or end of trial if earlier. |
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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 | No |
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 | 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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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
| 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 | 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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Next docetaxel administration or termination of treatment. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |