E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Extensive disease (ED) stage small cell lung cancer (SCLC) |
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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 |
To investigate the efficacy of ZK 219477 in chemotherapy naive patients with extensive disease SCLC (proof of concept) |
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E.2.2 | Secondary objectives of the trial |
To investigate the safety and tolerability of the above treatment |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Males or females aged >= 18 years
2. Histologically or cytologically proven SCLC
3. Stage of extensive disease defined by the presence of distant metastases
4. At least 1 unidimensionally measurable lesion (suitable for modRECIST evaluation)
5. WHO performance status 0 to 1
6. No previous SCLC-related chemotherapy
7. No previous SCLC-related surgery
8. No previous radiotherapy (excepting for brain metastases)
9. Adequate function of major organs and systems • Nervous system: - No Grade 2 or greater peripheral neuropathy • Hematopoietic: - Hemoglobin: >= 10 g/dL - WBC: >= 3,000/mm3 - Absolute neutrophil count: >= 1,500/mm3 - Platelet count: >= 100,000/mm3 • Hepatic: - Total bilirubin: normal - AST/ALT: <= 2.5 times the upper limit of normal • Renal: - Creatinine: <= 2 mg/dL • Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No arrhythmia needing continuous treatment • No other uncontrolled concurrent illness
10. Negative pregnancy test at enrollment (females of childbearing potential only)
11. Agreement to use highly effective contraception methods (intra-uterine contraceptive device IUCD, condoms, oral contraceptives, or other adequate barrier contraception) in females of child-bearing potential
12. Written informed consent
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E.4 | Principal exclusion criteria |
1. Superior vena cava syndrom or obstruction of any vital structure
2. Untreated malignant hypercalcemia
3. Pleural effusion as the only manifestation of disease
4. Extensive disease amenable to radiation therapy
5. Symptomatic brain metastases requiring whole-brain irradiation
6. Any concomitant malignancy excepting non-melanoma skin cancer or carcinoma in situ of the cervix
7. Pregnant or breast-feeding women
8. Any condition that in the opinion of the investigator could hamper the compliance with the study protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients with either complete response (CR) or partial response (PR) as best overall response |
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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.8.5 | 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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |