E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
advanced epithelial ovarian cancer or primary peritoneal cancer that has relapsed after prior therapy with a platinum/taxane-based chemotherapy. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033163 |
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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 |
The main objective of the Phase I of te study is to evaluate the safety and tolerability of volociximab in combination with liposomal doxorubicin to identify the recommended dose to be used in the second part (Phase II) of the study. The main objectives of the Phase II of the study are to evaluate the efficacy, the safety and tolerability of volociximab in combination with liposomal doxorubicin in advanced epithelial ovarian cancer or primary peritoneal cancer. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the Phase I are to evaluate the PK of volociximab in combination with liposomal doxorubicin. The secondary objectives of the Phase II of the study are to evaluate the pahrmacikinetic (PK) and the quality of life benefits (QoL)of volociximab in combination with liposomal doxorubicin in advanced epithelial ovarian cancer or primary peritoneal cancer. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]). 2.Females aged greater than or equal to 18 years old at the time of informed consent. 3.Advanced (Stage III or IV)histologically documented epithelial ovarian cancer or primary peritoneal cancer (excluding small, round-cell histologies). 4.Recurrent or persistent disease. 5.No more than 2 prior cancer treatment regimens, at least one of which must have included a platinum/taxane based therapy (carboplatinum, cisplatinum, or another organoplatinum compound). If the same regimen is given more than once, it will only count as one regimen. Similarly, if components of a regimen are given more than once using the same schedule, it will only count as one regimen. 6.Measurable disease, per RECIST, or evaluable disease (i.e., non target lesions only). 7.ECOG Performance Status less than or equal to 1. 8.Life expectancy greater than 12 weeks. 9.Subjects of child bearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment |
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E.4 | Principal exclusion criteria |
1.Clinical laboratory values greater than or less than the following laboratory thresholds: o Granulocyte count < 1500/microL o Platelet count < 75,000/microL o Hemoglobin < 8.5 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors; darbopoeitin [Aranesp] is permitted) o Serum bilirubin > 2.0 x upper limits of normal (ULN) o AST and ALT > 2.5 x ULN (AST and ALT >5 x ULN for subjects with liver metastasis) o Serum creatinine >2.0 mg/dL o International normalized ratio (INR) >1.5 o Activated partial thromboplastin time (aPTT) >1.5 x ULN 2. Unstable angina or a history of myocardial infarction within 6 months prior to Day 1. 3. New York Heart Association (NYHA) > or equal Grade II congestive heart failure. 4.Subjects who have received prior (liposomal) anthracycline or anthracenedione therapy. 5.Any investigational, anti cancer therapy within 6 weeks prior to Day 1. 6.Any non-investigational, anti cancer therapy within 4 weeks prior to Day 1. 7.Prior treatment with anti angiogenic agents. 8.Subjects who are taking concomitant immunomodulatory agents including, but not limited to, interferons, interleukins, systemic steroids, cyclosporine, tacrolimus, calcineurin inhibitors, chronic low dose methotrexate, or azathioprine. (The use of inhaled or intranasal steroids or oral steroids at a dose of < or equal 10 mg/day prednisone or its equivalent are permitted.) 9.Subjects who require treatment with an anti coagulant with the exception of low dose Aspirin (< or equal 81 mg/day), warfarin (< or equal 1 mg/day), or heparin for IV catheter patency. 10.Subjects with a left ventricular ejection fraction (LVEF) <50%. 11.History of stroke or transient ischemic attack within 6 months prior to Day 1. 12.Clinically significant peripheral vascular disease. 13.Evidence of bleeding diathesis or coagulopathy. (Note: Prior history of deep vein thrombosis will not exclude subjects from participating in this study.) 14.History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1. 15.Serious, non-healing wound, ulcer, or bone fracture. 16.Evidence of autoimmune disease including, but not limited to, ulcerative colitis, Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and other disease in which immune function or immune competence is known to be impaired. 17.Active infection requiring systemic antibiotics, antivirals, or antifungals including HIV/AIDS, hepatitis B, or hepatitis C infection. 18.Any history of lymphoproliferative disorder. 19.Known human anti-murine antibody (HAMA) and/or human anti-chimeric antibody (HACA). 20.Known central nervous system or brain metastases. 21.History of other malignancies within 3 years of Day 1, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal, or squamous cell skin cancer. 22.Pregnant (positive pregnancy test) or lactating. 23.Inability to comply with study and follow-up procedures. 24.Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that in the opinion of the Investigator gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk from treatment complications. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is PFS |
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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 | 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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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) | Yes |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |