E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Symtomatic malignant pleural and/ or peritoneal effusions regardless of the primary tumor site or histological charestistics |
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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 |
The primary objective is to evaluate the activity of sunitinib in patients with symptomatic malignant pleural and/or peritoneal effusions regardless of the primary tumor site or its histology. |
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E.2.2 | Secondary objectives of the trial |
The secondary aims are : - Antitumor activity of Sunitinib - Safety profile of Sunitinib - Intrapleural PK of Sunitinib - Translational studies of target inhibition - Time to treatment failure (TTF)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histopathologically confirmed malignancy. 2. Histologically or cytopathologically confirmed malignant pleural and/or peritoneal effusions. If both are present in any one patient, malignancy most be documented in at least one site. 3. Radiologically documented increase in pleural and/or peritoneal fluid over the past 6 weeks prior to enrollment into this study. 4. Disease extent is not amenable to standard therapy with curative intent, 5. Have refractory disease or a disease state were systemic options are either non-existant, considered not feasible or not justified, or refused. 6. Male or female, 18 years of age or older. 7. Resolution of all acute toxic effects of prior systemic therapy, radiotherapy or surgical procedure to NCI CTCAE Version 3.0 grade ≤1. Prior therapy with taxanes is allowed, but last administration must have dated at least 6 weeks prior to enrollment in this study. 8. Adequate organ function as defined by the following criteria: . • Total serum bilirubin ≤2 x ULN . • Serum transaminases <5 x ULN . • Serum creatinine ≤2 x ULN . • Absolute neutrophil count (ANC) ≥1000/mL without G-CSF) . • Platelets ≥75,000/mL . • Hemoglobin ≥8.0 g/dL 9. Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment. 10. Willingness and ability to comply with scheduled visits & study procedures.
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E.4 | Principal exclusion criteria |
1. Current treatment in another therapeutic clinical trial. 2. Congestive heart failure, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina or any unstable arrhythmia requiring medication. 3. Previous treatment with any anti-VEGF or anti-PDGF agent, or any other TKI. 4. Pregnancy or breastfeeding. Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator. Male patients must be surgically sterile or agree to use effective contraception. 5. Normal gastro-intestinal function, excluding patient subobstruction. 6. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. 7. Patients for whom obvious other treatment modalities for the underlying malignancy exist.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint for all patients is the frequency of non-progression at six weeks of continuous treatment. Non-progression is defined in 7.1. and includes patients of both strata and includes the absence of any need for a fluid evacuation procedure. |
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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 | Yes |
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) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | 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) | No |
E.8.2.2 | Placebo | No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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Due to the nature of this study, the number of patients to be enrolled is difficult to predetermine. It is estimated that up to 50 patients will be enrolled to this study combining stratum A and B. The main endpoint for all patients is non-progression at 6 weeks |
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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 | |
E.8.9.1 | In the Member State concerned days | |