E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Resectable Non Small Cell Lung Cancer NSCLC with stage IA or IB |
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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 | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
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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 |
Evaluate tumor shrinkage based on change in tumor volume using high-resolution CT scans of the thorax and advanced image processing techniques following treatment with pazopanib. |
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E.2.2 | Secondary objectives of the trial |
Evaluate change in metabolic activity using PET/CT. Evaluate the safety and tolerability of pazopanib in subjects with Stage IA or IB NSCLC. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Signed, written informed consent prior to performing any study-related procedures, including the collection of a fresh tumor biopsy sample. 2. Subjects 21 years of age with a life expectancy of 12 weeks. 3. The time between initial diagnosis and the scheduled surgery date allow for the subject to receive a minimum of 2 weeks or a maximum of 6 weeks treatment with pazopanib. Note At least 4 weeks between initial biopsy and surgery must be planned to allow for the one week wait following the final biopsy and the 1 week washout period. 4. Eastern Cooperative Oncology Group ECOG performance status PS 0 or 1. 5. Histologically or cytologically confirmed stage IA and IB NSCLC according to the International Staging System Mountain, 1997 and must be candidates for surgical resection. 6. Disease must be measurable according high-resolution CT scan-assisted volumetric measurement, as specified in Section 14.5, Appendix 5 . 7. No prior chemotherapy, radiation therapy, immunotherapy, biologic therapy or anti-angiogenic therapy. 8. Fresh tumor biopsy must be provided by all subjects before and after treatment with pazopanib for apoptosis and relevant biomarker analysis. 9. Adeguate Organ System function- as defined in the protocol 10. Ability to swallow or retain oral medication |
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E.4 | Principal exclusion criteria |
1. History of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected, non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. 2. 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; minor surgical procedures such as fine needle aspiration or core biopsy within 1 week prior to beginning therapy are also excluded. 3. History or clinical evidence of central nervous system CNS metastases or leptomeningeal carcinomatosis. Routine screening with CNS imaging studies computed tomography CT or magnetic resonance imaging MRI is required only if clinically indicated. 4. History of hemoptysis. 5. Malabsorption Syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded. 6. Active or uncontrolled infection 7. Concurrent treatment with an investigational agent or participation in another clinical trial or the use of an investigational anti-cancer drug within 30 days of 5 half-lives, whichever is longer, preceding the first dose of pazopanib 8.Prior use of an investigational or licensed drug that targets either VEGF or VEGF receptors. 9. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.10.Corrected QT interval QTc prolongation defined as QTc interval 470 msecs 11.History of any one of the following cardiac conditions within the past 6 months Cardiac angioplasty or stenting,Myocardial infarction,Unstable angina 12.Has Class II, III or IV heart failure as defined by the New York Heart Association NYHA functional classification system.13.Poorly controlled hypertension systolic blood pressure SBP of 140mmHg, or diastolic blood pressure DBP of 90mmHg Note Initiation or adjustment of antihypertensive medication s is permitted prior to study entry. The blood pressure BP must be re-assessed on two occasions that are separated by a minimum of 5 minutes. The mean SBP/DBP values from both BP assessments must be 140/90mmHg in order for a subject to be eligible for the study.14. Presence of any non-healing wound, fracture, or ulcer, or the presence of symptomatic peripheral vascular disease. 15.Receiving therapeutic warfarin or heparin as a concurrent medication. Note Prophylactic low-dose warfarin is permitted. 16.Evidence of bleeding diathesis or coagulopathy |
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E.5 End points |
E.5.1 | Primary end point(s) |
Response rate defined as the percentage of subjects achieving at least 50 tumor volume reduction following treatment with pazopanib. |
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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 | No |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | 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) | 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 |
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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 | 2 |
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 | 2 |