E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stage IIIB/IV Non-small cell lung cancer |
|
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 collect long-term safety and tolerability data from patients receiving CYC202. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate tumour response data following prolonged CYC202 treatment. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Eligible patients completing the full treatment period with CYC202 in a CYC202 clinical trial with a disease status of at least stable disease at the end of the trial. At least one measurable lesion as defined in the original trial protocol. WHO performance status of 0-2. Life expectancy > 3 months. Adequate clinical pathology values (Blood pathology values as within the inclusion criteria of the first CYC202 trial; Creatinine clearance >= 60ml/min; Bilirubin <= 1.25 x ULN; Alkaline phosphatase, alanine transaminase and aspartate transaminase <= 2.5 x ULN; Prothrombin time within the normal range for the institution). Signed informed consent prior to start of any study specific procedures. Ability to co-operate with treatment and follow-up. Female patients of child-bearing potential must have a negative pregnancy test and use at least one form of contraception as approved by the Investigator for 4 weeks prior to the study and 4 months after. Male patients must use a barrier method of contraception for 4 weeks prior to the study and 4 months after. |
|
E.4 | Principal exclusion criteria |
Patients who, in the opinion of the Investigator, showed poor treatment compliance in the original CYC202 clinical trial; or poor compliance of the study centre during evaluation visits. Patients who withdrew consent during the original CYC202 clinical trial. Any concomitant condition that could compromise the objectives of this study and the patient's compliance. Patients who cannot swallow or patients with chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the tested product. Pregnant or lactating woman. Major thoracic and/or abdominal surgery in the preceding 3 weeks. Known currently active HIV, HBV or HCV infection. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Determination of safety and tolerability: Assessment of Adverse Events; Baseline and serial examination of physical status, vital signs, blood haematology, blood chemistry, urine |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
|
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
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
|
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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |