E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
metastatic pancreatic cancer |
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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 |
Efficacy (tumor response) of volociximab in combination with gemcitabine in patients with metastatic pancreatic cancer, as defined using Response Criteria for Solid Tumors (RECIST). |
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E.2.2 | Secondary objectives of the trial |
1. Evaluate efficacy of volociximab using secondary efficacy measures. 2. Evaluate safety of volociximab in combination with gemcitabine. 3. Evaluate the pharmacokinetics (PK) of volociximab. 4. Evaluate immunogenicity of volociximab.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Males and females of at least 18 years of age with histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas who may have received prior immunotherapy (including monoclonal antibodies) or vaccine therapies;
2. Measurable disease according to Response Criteria for Solid Tumors (RECIST);
3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1;
4. Negative pregnancy test (women of child-bearing potential only);
5. Pre-treatment laboratory levels that meet specific criteria;
6. Signed informed consent, including permission to use protected health information. |
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E.4 | Principal exclusion criteria |
1. Prior treatment with volociximab (M200) or alpha5beta1 integrin inhibitors (antibodies or small molecules) or gemcitabine and other chemotherapeutic regimens;
2. Known hypersensitivity to murine proteins or chimeric antibodies or other components of the product; use of any IMP within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer);
3. Monoclonal antibody therapy within 4 weeks of volociximab (M200) administration;
4. Documented CNS tumor or CNS metastasis;
5. History of thromboembolic events and bleeding disorders within the past year;
6. Medical conditions that may be exacerbated by bleeding.
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of patients in each dose cohort with a confirmed tumor response at any time during the study.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
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 | 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) | No |
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 | 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 | 4 |
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 | 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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The study is considered completed on the date that the 6-month follow-up assessment has been performed on the last patient. |
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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 | 6 |
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 | 6 |