E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-small-cell lung cancer |
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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 document toxicity related to NFV given in combination with radiotherapy |
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E.2.2 | Secondary objectives of the trial |
To correlate the drug's efficacy with biological endpoints of perturbation of the signal transduction pathway To assess the enhancement of radiation response in NSCLC by inhibition of Akt activation with NFV |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Histologically verified NSCLC including squamous cell carcinoma, adenocarcinoma, and large cell anaplastic carcinoma - Patients with stage II or III NSCLC unsuitable for radical treatment to the primary tumour, where high dose palliative radiotherapy is considered appropriate (CT scan to have been performed within 28 days prior to trial entry) - Performance status WHO 0 - 2 - clinically or radiographically measurable disease - absolute neutrophil count >=1500/mm3 - Platelets ≥100 x 109/L (≥100000/mm3) - Serum creatinine ≤1.5 times upper limit of normal - Bilirubin ≤1.5 times upper limit of normal - Serum AST ≤ 1.5 x upper limit of normal
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E.4 | Principal exclusion criteria |
- Patients with metastatic disease - Patients diagnosed with heart disease or diabetes mellitus - Previous radiotherapy to the chest - Chemotherapy within 4 weeks of the start of experimental treatment - The presence of another malignancy, where the extent of disease or treatment for that condition may interfere with the study endpoints - Patients already taking a Protease Inhibitor - Patients taking drugs contraindicated with NFV, unless stopped 2 weeks or more before start of study:
Antiarrhythmics amiodarone, quinidine Antimycobacterials rifampicin Ergot derivatives Dihydroergotamine, ergonovine, ergotamine, methylergonovine Herbal products St. John’s Wort HMG-CoA Reductase Inhibitors simvastatin, atorvastatin Neuroleptics pimozide Sedatives/hypnotics midazolam, Others Viagra, terfenadine
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E.5 End points |
E.5.1 | Primary end point(s) |
•Treatment related toxicity (particularly lung and oesophageal) assessed by the World Health Organisation (WHO) Common Toxicity Criteria (CTCAE)v3 |
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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 | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
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) | Yes |
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 |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
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.8.1.7.1 | Other trial design description |
phase I element will not be randomised |
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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 |
radiotherapy alone vs radiotherapy with IMP |
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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
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |