E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Conditions for which carboplatin is indicated for:
1. Advanced ovarian carcinoma of epithelial origin in: - first line therapy - second line therapy, after other treatments have failed.
2. Small cell carcinoma of the lung, in association with other chemotherapeutic agents. |
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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 |
The main objective of the study is to evaluate the concept of dose-banding using pharmacokinetic measures (AUC, AUMC, Cmax, tmax) as surrogates for tissue drug exposure. ("Dose-banding" is a method of fitting the chemotherapy dose calculated for each patient to pre-defined "bands" or dose-ranges, and providing these with standard, pre-prepared infusions). |
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E.2.2 | Secondary objectives of the trial |
To determine if the relationships between pharmacokinetic measures (AUC, AUMC, Cmax, tmax) and pharmacodynamic measures (thrombocytopenia) for carboplatin are influenced by dose-banding, as opposed to individualised dosing. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Patients aged over 18. - Eligible to receive carboplatin as single agent or in combination therapy, according to institutional guidelines. - At least two planned carboplatin cycles. - Ability to give informed consent.
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E.4 | Principal exclusion criteria |
- Patients with ascites, oedema, or other expanded body space. - Patients receiving intravenous (IV) hydration therapy. - Pregnancy or breast feeding. - Patients who do not understand the Patient Information sheet in English. (Considering the size and purpose of this study, it would not be economically feasible to provide separate information material in other languages for anyone who does not fully understand the Patient Information).
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E.5 End points |
E.5.1 | Primary end point(s) |
Deviation in observed target area under the plasma concentration - time curve (AUC) from predicted target AUC, when carboplatin doses are determined with the Calvert-formula* (Dose (mg) = AUC (mg x min/ml) x (Glomerular Filtration Rate (GFR, ml/min) + 25)). This will be studied following exact individualised dosing and dose-banding, respectively.
*Reference: Calvert AH, Newell DR, Gumbrell LA, et al. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol 1989,7:1748-1756. |
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 |
Dose-banded doses of carboplatin. |
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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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | 5 |
E.8.9.1 | In the Member State concerned days | |