E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Malignant effusion in cancer patients requiring frequent centesis, at least two within six weeks |
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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 of this phase I/II study is to investigate the efficacy and the dose/response relationship of bevacizumab in patients with malignant and non-malignant effusions that require frequent centesis. |
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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 |
Male and female patients with a histologically proven diagnosis of malignant disease and malignant effusion requiring frequent centesis (at least 2 centeses within 6 weeks prior to study entry) Succesful centesis prior to study entry Age between 18 years – 75 years Eastern Cooperative Oncology Group (ECOG) Performance Status £ 4 Adequate liver function: bilirubin £ 1,5 times the upper limit of normal (ULN) or £ 2 x ULN in patients with liver metastasis; alanine transaminase (ALT) and aspartate transaminase (AST) £ 2 x ULN or £ 3 x ULN in patients with liver metastasis Adequate renal function (creatinine £ 1,5 times the ULN, creatinine clearance ≥ 60 ml/min) Childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after the trial Negative urinary or serum pregnancy test in women with intact reproductive organs and women less than one year after the menopause Life expectancy of at least 3 months Signed written informed consent
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E.4 | Principal exclusion criteria |
Treatment with any investigational agent within 4 weeks before enrolment into the study Concomitant cytotoxic chemotherapy or any other anti-tumor therapy, unless malignant effusion has evolved or worsened during this specific therapy. Any prior chemotherapy is allowed, but has to be finished or stopped at least 4 weeks prior to study entry Prior treatment with bevacizumab within 4 weeks prior to study entry Major surgery within 6 weeks before study enrolment Radiotherapy within the last 2 weeks before study enrolment or no recovery from toxic effects of radiotherapy Pregnant or lactating women Serious uncontrolled infections (bacterial or viral). New York Heart Association (NYHA) class IV congestive heart failure History of documented poorly controlled hypertension; clinically significant valvular heart disease; high risk uncontrolled arrhythmias Other serious illness or medical condition incompatible with the study treatment at the discretion of the investigator History of uncontrolled seizures, central nervous disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or adversely affecting compliance to study drugs Unwilling or unable to comply with the requirements of the protocol and visit schedule for the duration of the study Coagulation disorder (Normotest < 50%) or severe thrombocytopenia (< 50 G/l) Active bleeding Patients with Ovarian cancer
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this study is the centesis free interval (CFI) as compared to the pretreatment CFI. |
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |