E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Resectable NonSmall Cell Lung Cancer, Stage IA/IB |
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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 |
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 |
1. Evaluate change in metabolic activity using PET/CT. 2. 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 Protocol 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. Adequate 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 3 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 or 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. 14. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib. 9. Corrected QT interval (QTc) prolongation defined as QTc interval > 470 msecs. 10. History of any one of the following cardiac conditions within the past 6 months: Cardiac angioplasty or stenting, Myocardial infarction, Unstable angina 11. Has Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system. 12. 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. 13. Presence of any non-healing wound, fracture, or ulcer, or the presence of symptomatic peripheral vascular disease. 14. Receiving therapeutic warfarin or heparin as a concurrent medication. Note: Prophylactic low-dose warfarin is permitted. 15. 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 | 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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | No |
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.8.2 | 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
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
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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Last Subject Last Visit, as defined in the protocol |
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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 | 0 |
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 | 0 |