E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
- Male and female patients with NSCLC - Complete resection of the primary tumour - Single surgically resected pathological stage I NSCLC lesion: consisting of a tumor < 7 cm in greatest dimension (see TNM staging on Appendix 10). - No regional lymph node involvement.
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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 | 10029517 |
E.1.2 | Term | Non-small cell lung cancer stage I |
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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 evaluate ‘feasibility of regimen’ by measuring compliance in patients with once-daily (QD) pazopanib, or placebo, dosed according to protocol, based on the proportion (%) of patients that receive pazopanib, or placebo, for at least 12 weeks within 24 weeks of randomization. |
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E.2.2 | Secondary objectives of the trial |
• Detailed assessment of compliance. • Comparison of the incidence and severity of AEs and other safety measures in patients treated with pazopanib and placebo. • Comparison of the reporting profile of AEs of interest during long-term follow-up with pazopanib versus placebo. • Comparison of the rates of loco-regional and distant recurrences in the pazopanib treatment arm in the Phase III component of the study compared with placebo. • Comparison of QoL in patients treated with pazopanib versus those treated with placebo using the EORTC-QLQ-C30 with lung cancer-specific module (LC-13) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Complete resection of the primary tumour and local extension has to be performed. All margins must be free of microscopical disease. At the time of resection, a complete mediastinal lymph-node resection or lymph-node sampling is required. Surgeons are encouraged to dissect or sample all accessible nodal levels. 2. Single surgically resected pathological stage I NSCLC lesion: consisting of a tumor < 7 cm in greatest dimension (see TNM staging on Appendix 10). 3. No regional lymph node involvement. 4. Pre-operative petscan 5. Satisfactory healing of surgical wound. 6. Patients between 18 and 70 years of age. 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. 8. Recruited to the study and available to start treatment investigational product at least 4 weeks but no longer that 8 weeks after the surgical resection of the NSCLC. 9. No approved or investigational anti-cancer therapy concurrently or in the 5 years prior to start of study drug, including tumor embolization, chemotherapy, radiation therapy, immunotherapy, hormone therapy, biologic therapy, or anti angiogenic therapy (e.g., inhibitors of VEGF or VEGFR). 10. Adequate organ system function 11. Ability to swallow and retain oral medication. 12. A female is eligible to enter and participate in this study if she is of: Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) 13. French Patients: in France, a patient will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security insurance.
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E.4 | Principal exclusion criteria |
1. Prior malignancy. Note: Patients who have had another malignancy and were treated more than 5 years ago and have since been considered cured, or patients with a history of basocellular skin carcinoma or in situ carcinoma of the uterine cervix are eligible. 2. Presence of any concurrent disease or condition that would make the subject inappropriate for study participation including any unresolved or unstable, serious toxicity from prior administration of another investigational drug or any serious medical disorder that would interfere with the subject's safety, obtaining informed consent, or compliance with all study related procedures. 3. Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study. 4. History or clinical evidence of nodal or distant metastases (screening of brain metastasis is mandatory). 5. Bronchioalveolar carcinoma of lobar or multi lobar involvement. Bronchioalveolar carcinomas presenting as a discrete solitary radiological mass or nodule are eligible. 6. History of human immunodeficiency virus infection or chronic hepatitis B or C. 7. History of hemoptysis after resection of lung cancer. 8.Clinically significant gastrointestinal abnormalities 9. Presence of active or uncontrolled infection. 10. Evidence of active bleeding or bleeding diathesis. 11. History of severe cardiovascular conditions within the past 6 months: 12. Poorly controlled hypertension 13. Following abnomalies on ECG : Q wave, ischemia, QT > 450 msec, atrio-ventricular block 2 or 3, atrial fibrilation 14. Therapeutic anticoagulation treatment. 15. Chronic daily treatment with aspirin (≥ 325 mg/day) or non-steroidal anti-inflammatory agents known to inhibit platelet function. Treatment with dipyridamole, ticlopidine, clopidogrel and/or cilostazol is also not allowed. 16. Pregnant or lactating female. 17. Concurrent treatment with an investigational agent or participation in another clinical trial. 18. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.
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E.5 End points |
E.5.1 | Primary end point(s) |
The end-point for the phase II component of the study is compliance. A patient will be classified as complier if he received pazopanib (or placebo) for at least 12 weeks, whatever the dose, in 24 weeks from randomization. Patients who stop treatment prematurely in the first 12 weeks due to a lung cancer recurrence or who death nor related to pazopanib will not be evaluable for compliance. |
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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 | No |
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 | 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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Yes |
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 | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
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 | 53 |
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 | Yes |
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 | 6 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |