E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with advanced or metastatic non small cell lung cancer (NSCLC) stage IIIB or IV who relapsed after or failed first-line chemotherapy |
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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 |
objective tumour response evaluated according to the RECIST criteria
(The present trial will be performed to evaluate whether BI 2536 may be effective in the treatment of advanced or metastatic NSCLC of stage IIIB or IV in patients who relapsed after or failed first-line therapy. A secondary aim is to identify the most suitable dosage schedule for the further Phase II and III clinical programme of BI 2536. To achieve this objective two dosage schedules are compared. A single dose of 200 mg BI 2536 administered on day one of a treatment course will be compared with 50 mg BI 2536 administered on days one, two and three of a treatment course. Furthermore, an assessment is planned to be made whether an intraindividual dose escalation is feasible.) |
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E.2.2 | Secondary objectives of the trial |
1.) progression free survival 2.) overall survival 3.) duration of overall response 4.) clinical tumour assessment 5.) quality of life assessment 6.) BI 2536 plasma concentrations 7.) incidence and intensity of adverse events graded according to CTCAE 8.) incidence of dose limiting toxicity 9.) laboratory investigations 10.) vital signs
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.) male or female patient aged 18 years or older 2.) patient with histologically or cytologically confirmed advanced or metastatic NSCLC of stage IIIB or IV 3.) patient who has relapsed or failed prior first-line chemotherapy for advanced or metastatic disease 4.) patient with at least one tumour lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT scan 5.) life expectancy of at least three months 6.) Eastern co-operative oncology group (ECOG) performance score of 2 or less 7.) patient must have given written informed consent which must be consistent with international conference on harmonisation – good clinical practice (ICH-GCP) and local legislation
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E.4 | Principal exclusion criteria |
1.) hypersensitivity to the trial drug or the excipients 2.) persistence of toxicities of prior anti cancer therapies which are deemed to be clinically relevant 3.) known secondary malignancy requiring therapy 4.) brain metastases which are symptomatic or require therapy 5.) absolute neutrophil count less than 1,500/mm3 6.) platelet count less than 100,000/mm3 7.) haemoglobin less than 9 mg/dl 8.) aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal, or AST or ALT greater than 5 times the upper limit of normal in case of known liver metastases 9.) bilirubin greater than 1.5 mg/dl (> 26 micromol/l, SI unit equivalent) 10.) serum creatinine greater than 2.0 mg/dl 11.) concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with trial requirement or which are considered relevant for the evaluation of the efficacy or safety of the trial drug 12.) chemo-, hormone- or immunotherapy within the past four weeks or within less than four half-life times of the previous drug prior to treatment with the trial drug (whatever is the longest period) 13.) radiotherapy within the past four weeks prior to treatment with the trial drug 14.) men or women who are sexually active and unwilling to use a medically acceptable method of contraception during the trial 15.) pregnancy or lactation 16.) treatment with any other investigational drug within the past four weeks or within less than four half-life times of the investigational drug before treatment with the trial drug (whatever is the longest period) 17.) patient unable to comply with the protocol 18 ) patients who are considered eligible by the investigator for other second-line chemotherapy, radiotherapy or immunotherapy will not be included in the trial 19) patients who have received more than two lines of prior anti-tumour therapy for advanced or metastatic non small cell lung cancer
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E.5 End points |
E.5.1 | Primary end point(s) |
objective tumour response evaluated according to the RECIST criteria |
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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 | 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 | Yes |
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 | 8 |
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
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The clinical trial will be considered completed as soon as the last patient has completed his / her last visit. In case the trial will be finished by the sponsor when patients are still being treated with the trial drug, the patients may continue in the trial in case no follow-up trial was/will be set up. These patients will be reported as an addendum to the final report as soon as they have completed 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 | 1 |
E.8.9.1 | In the Member State concerned days | |
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 | 1 |