E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | HLGT |
E.1.2 | Classification code | 10041299 |
E.1.2 | Term | Soft tissue sarcomas |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate whether treatment with pazopanib improves the outcome of patients with metastatic soft tissue sarcoma, when compared to placebo. |
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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 |
• Histological evidence of high or intermediate grade of STS. Eligible tumor types are listed in the protocol • Confirmed disease progression by RECIST within the past 6 months prior to study enrolment. or within 12 months if only received prior systemic (neo)–adjuvant therapy • Metastatic disease • Measurable disease according to RECIST • Patients may have received a maximum of 4 prior lines of systemic therapies for advanced disease of which no more than two lines should be combination regimens. (neo)adjuvant/maintenance treatments are not counted for this criterion • Last dose of prior therapy can be given up to 14 days prior to starting the study; all ongoing toxicity from prior anti-cancer therapy are grade 1 (except alopecia) or have resolved. • patients whose disease has progressed on or after anthracycline based regimen • Patients whose disease has progressed on or after available standard chemotherapies at the treating institution except if medically contraindicated or refused by the patient • WHO PS 0-1 • adequate bone marrow, coagulation, liver and renal function • Clinically normal cardiac function based on the institutional lower limit of normal (LVEF assessed by MUGA or ECHO) and normal 12 lead ECG (no prolongation of corrected QT interval (QTc) > 480 msecs) less than 14 days prior to treatment start and no history of any one or more of the cardiovascular conditions listed in the protocol within the past 6 months • Contraception • Written informed consent |
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E.4 | Principal exclusion criteria |
Exclusion Criterion 3 revised (note - section re-organized) • Previous treatment with inhibitors of angiogenesis and/or VEGF or VEGFR-targeting agents. mTOR inhibitors are not considered as inhibitors of as inhibitors of angiogenesis • Known history of central nervous system metastases or leptomeningeal tumor spread • Prior history of malignancies other than sarcoma (exception noted in the protocol) • Ongoing toxicity from prior anti-cancer therapy > Grade 1 (except alopecia) and/or that is progressing in severity • Concurrent anti-cancer therapy including: chemotherapy, immunotherapy, biologic therapy, investigational therapy, radiotherapy, targeted agents or hormonal therapy within 14 days or five half-lives of a drug prior to the first dose of study medication and until 15 days after the last dose of study medication • Use of any investigational agent during study treatment and until 15 days after the last dose of study medication • Poorly controlled hypertension defined at baseline as blood pressure (BP) >150/90 • Cerebrovascular accident at any time in the past, transient ischemic attack in the past 6 months, deep venous thrombosis (DVT) or a pulmonary embolism in the past 6 months; note: patients with recent DVT who have been treated with therapeutic anti-coagulating agents and remained stable for at least 6 weeks are eligible • History of clinically significant gastrointestinal disorders • Endobronchial lesions and/or lesions infiltrating major pulmonary 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 • 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 Progression Free Survival. Progression will be defined according to RECIST. |
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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 | No |
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 | No |
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 | 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 | No |
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.8.3 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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 | 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 the trial occurs when the criteria described in Section 8.4 of the protocol have been satisfied. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |