E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Nausea and vomiting after using moderate emetogenic cytostatics such as etoposide and cisplatin for the treatment of patients with metastatic lung carcinoma. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10056989 |
E.1.2 | Term | Nausea post chemotherapy |
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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 study the pharmacokinetics of etoposide with and without the addition of aprepitant in patients with metastatic lung carcinoma treated with the standard CE regimen. |
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E.2.2 | Secondary objectives of the trial |
To study the efficacy and safety of the addition of aprepitant to the anti-emetic regimen in patients with metastatic lung carcinoma treated with the standard CE regimen. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject is at least 18 and not older than 75 years of age on the day of the first dosing. 2. Subject is abel and willing to sing the Informed Consent Form prior to screening evaluations. 3. Subject has an indication for treatment with CE regimen. 4. Subject is expected to receive at least 2 cycles with CE regimen. 5. Subject is able to swallow capsules. |
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E.4 | Principal exclusion criteria |
1. Documented history of sensitivity/idiosyncrasy to aprepitant capsules or excipients. 2. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. 3. History of or current abuse of drugs, alcohol or solvents. 4. Inability to understand the nature and extent of the trial and the procedures required. 5. Participation in a drug trial within 30 days prior to the first dose. 6. Febrile illness within 3 days before the first dose. 7. Concomitant use of agents that are known to interfere with aprepitant pharmacokinetics (see appendix A) 8. Abnormal liver or renal function, as indicated by serum liver enzymes >5 times ULN, total bilirubin >1.5 times ULN (see appendix B) or creatinine clearance <60 mL/min |
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E.5 End points |
E.5.1 | Primary end point(s) |
Aprepitant acts initially as a moderate inhibitor of CYP3A4 followed by a short period of CYP3A4 induction. Etoposide is a substrate of CYP3A4 and may therefore be subject to a drug interaction with aprepitant. CE can be classified as a highly emetogenic chemotherapautic regimen, and the use of aprepitant may therefore be considered when no clinically relevant drug interaction with etoposide can be determined. |
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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 | 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 | 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 | 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 |
standard anti-emetic regimen |
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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 | 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
| |
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 | |
E.8.9.1 | In the Member State concerned days | |