E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non Small Cell Lung Cancer patients non progressive after first line chemotherapy |
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E.1.1.1 | Medical condition in easily understood language |
Non Small Cell Lung Cancer patients non progressive after first line chemotherapy |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 compare the therapeutic benefit of maintenance pazopanib versus placebo after first-line treatment for NSCLC. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Tumor assessment must occur within 7-42 days after day 1 of last chemotherapy cycle (patient must have received 4 to 6 chemotherapy cycles) and must be non progressing. Three weeks (+ 7 days) will be the maximum time allowed from the documentation of non–progression to start maintenance therapy. All evaluations have to be done within 3 weeks (+ 7 days) prior to treatment start. However hematology and serum chemistry and clinical symptoms must be done within 2 weeks (+/-2 days) prior to treatment start with the exception of potassium which must be checked and be within normal local laboratory limits within 72 hours of randomization. |
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E.4 | Principal exclusion criteria |
- known EGFR mutations - prior TKI or prior bevacizumab/cetuximab (as part of induction therapy) - Malignancy other than Non Small Cell Lung Cancer within past 2 years - ongoing toxicity from prior anti-cancer therapy that is > Grade 1 (except alopecia) and/or that is progressing in severity - poorly controlled hypertension defined at baseline as blood pressure (BP) >140/90 - cerebrovascular accident at any time in the past, transient ischemic attack, deep venous thrombosis (DVT) or pulmonary embolism in the past 6 months - history of clinically significant gastrointestinal disorders including: malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, known intraluminal metastatic lesion/s with risk of bleeding, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment. - endobronchial lesions and/or lesions infiltrating major pulmonary vessels. - lesions infiltrating major pulmonary vessels (contiguous tumor and vessels) - evidence of active bleeding or bleeding diathesis. - hemoptysis within 6 weeks prior to first dose of study drug. - prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer. - intake of amiodarone within 6 months prior to first dose of study drug. - 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) |
overall survival (OS) in patients randomized to maintenance pazopanib versus placebo |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
approximately 60 months after the first patient randomized |
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E.5.2 | Secondary end point(s) |
-progression free survival (PFS). -toxicity profile of pazopanib -quality-of-life on maintenance therapy -Time to treatment discontinuation (TTD) -C-Reactive Protein (CRP) in detection of progression in maintenance phase. -Health Economics data |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Interim futility analysis is based on PFS and will take place at approximately 19 months after the first patient randomized. For the final analysis, all secondary endpoints will be evaluated at the same time as the primary endpoint, i.e. at approximately 60 months.
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
to compare QOL,to compare discontinuation rate/treatment compliance,Translational research |
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
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 | No |
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 | 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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End of study occurs when all of the following criteria have been satisfied: 1. All patients have either been treated for a minimum of six months or have been off treatment for at least thirty days 2. The trial is mature for the analysis of the primary endpoint 3. The database has been fully cleaned and frozen for this analysis |
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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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |