E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Circulating tumor cells in urothelial cancer patients relapsing after or refractory to platinum based first line chemotherapy |
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E.1.1.1 | Medical condition in easily understood language |
Evaluation of circulating tumor cells in patients with urothelial cancer, circulating tumor cells might give information on the disease and its progress |
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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 the presence and number of biomarkers (CTC and HER-2 positivity of detected CTCs) in urothelial cancer patients who have progressed after platinum combination chemoterapy or who are platinum refractory |
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E.2.2 | Secondary objectives of the trial |
- Exploratory analysis of outcome parameters, to create a hypothesis about the potential value of CTC levels in the prognosis
- Investigating the presence and the cut-off-level of circulating tumor cells (CTCs) and HER-2 positive CTCs in patients with UC after platinum based combination chemotherapy
- Correlation of CTC presence and percentage with the published clinical prognostic factors (Bellmunt) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Written informed consent
- Male or female patient with urothelial cancer aged ≥ 18 years
- Patient progressing during or after platinum containing combination chemotherapy or within 12 months after platinum containing chemotherapy in the perioperative setting |
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E.4 | Principal exclusion criteria |
Patient of childbearing potential (female patients only) |
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E.5 End points |
E.5.1 | Primary end point(s) |
The following biomarkers will be evaluated:
- Circulating tumor cells (CTC)
- HER-2 positivity of detected CTCs
- HER-2 positivity of tumor tissue |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Blood sample examination for CTCs and HER-2
Analysis of tumor block slides |
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E.5.2 | Secondary end point(s) |
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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 | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | 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 | 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 | 11 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |