E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 |
1. High or intermediate grade of Soft Tissue Sarcoma. Eligible tumour types are listed in the protocol 2. The objective progression of disease will be assessed by investigator according to RECIST within 6months prior to study enrolment or within 12months prior to study enrolment, if the only prior systemic therapy of the sarcoma was given in the adjuvant or pre-operative setting 3. Metastatic disease 4. Measurable disease 5. Patients may have received a maximum of 4 prior lines of systemic therapies for advanced disease. (neo-)adjuvant/maintenance treatments are not counted for this criterion. 6. Last dose of prior therapy can be given up to 14days prior to starting the study; all ongoing toxicity from prior anti-cancer therapy are grade 1 or resolved 7. Patients whose disease has progressed on or after anthracycline therapy 8. Patients whose disease has progressed on or after available standard chemotherapies at the treating institution except if medically contraindicated or refused by the patient 9. Patients may have been intolerant or progressed on or after their last therapy 10. WHO PS 1 11. Normal bone marrow, liver, renal and cardiac function 12. Contraception 13. Written informed consent |
|
E.4 | Principal exclusion criteria |
1. No known history of leptomeningeal or brain metastases 2. No patient with poorly controlled hypertension (at baseline BP>150/90 is defined as poorly controlled) 3. No history of clinically significant gastrointestinal abnormalities 4. Exclude patients who have suffered a cerebrovascular accident at any time in the past, patients who have suffered a transient ischemic attack in the past 6months, patients who have suffered a deep vein thrombosis (DVT) or a pulmonay embolism in the past 6months. Nb. patients with recent DVT who have been treated with therapeutic anti-coagulating agents and remained stable for at least 6weeks are eligible. 5. No evidence of active bleeding or bleeding diathesis 6. No hemoptysis within 6weeks of first dose of study drug. Nb. any patient with a prior history of hemoptysis associated with metastatic disease must have a bronchoscopy to rule out endobronchial lesion would be excluded from study. 7. No prior major surgery or trauma within 28days prior to treatment start 8. Restriction for concomitant medications (see Chapter 5.8) 9. Patients who have been previously treated with inhibitors of angiogenesis and/or VEGF or VEGFR-targeting agents. mTOR inhibitors are not considered as inhibitors of angiogenesis. |
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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 | 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.8.3 |
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 | 8 |
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
|
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 |