E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced pancreatic cancer in subject with unresectable disease who have received no prior chemotherapy or radiation therapy for pancreatic cancer. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033575 |
E.1.2 | Term | Pancreas cancer |
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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 |
To determine the effect on overall survival of adding MORAb-009 to gemcitabine in subjects with previously untreated unresectable pancreatic cancer. |
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E.2.2 | Secondary objectives of the trial |
To determine progression-free survival (PFS). To assess changes in overall response rate (ORR). To determine the changes of the Karnofsky performance status (KPS). To determine safety of MORAb-009 when administered with gemcitabine.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
° MORAB-009 SERUM LEVELS same version as protocol V2.0 11 November 2007 - To monitor MORAb-009 serum levels.
° Positron Emission Tomography (PET) Scan same version as protocol V2.0 11 November 2007 (For US sites only) -To determine changes in tumor metabolism by positron emission tomography (PET) (substudy at select sites).
°Pharmacogenomic sub-study same version as protocol V2.0 11 November 2007 - To investigate possible associations between human leukocyte antigen (HLA) types and survival. - To identify molecular markers as a surrogate for immunotherapy response.
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E.3 | Principal inclusion criteria |
1.Female or male subjects, ≥ 18 years of age, with pathologically confirmed diagnosis of pancreatic adenocarcinoma.
2.Must have measurable disease, as defined by RECIST (see Appendix A). RECIST evaluation must have occurred within 4 weeks prior to study entry.
3.Must have newly diagnosed, unresectable disease and have received no prior chemotherapy, radiation therapy or surgery with curative intent for their pancreatic cancer.
4.Karnofsky performance status of greater than or equal to 70 %.
5.Female subjects of childbearing potential and all male subjects must be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period and 2 months after the last dose of test article.
6.Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1.
7.Laboratory and clinical results within the 2 weeks (14 days) prior to Study Day 1 as follows: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin ≥ 9 g/dL Serum bilirubin ≤ 2.0 mg/dL Aspartate transaminase (AST)* ≤ 5 x upper limit of normal (ULN) Alanine transaminase (ALT)* ≤ 5 x ULN Alkaline phosphatase* ≤ 5 x ULN Serum creatinine ≤ 2.0 mg/dL Stenting to reduce liver functions to qualifying levels is permitted. * Subjects with liver function abnormalities ≤ 5 x ULN are eligible only if in the opinion of the investigator they are due to disease obstruction of the bile ducts or metastatic disease.
8.Must be willing and able to provide written informed consent.
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E.4 | Principal exclusion criteria |
1.Known central nervous system (CNS) tumor involvement.
2.Evidence of other active malignancy requiring treatment.
3.Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months).
4.Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible).
5.Active serious systemic disease, including active bacterial or fungal infection.
6.Active viral hepatitis or symptomatic human immunodeficiency virus (HIV) infection. Positive serology alone is not exclusionary.
7. Prior surgery with curative intent for pancreatic cancer.
8.Prior or current chemotherapy or radiation therapy for their pancreatic cancer. Palliative radiation for distant metastases (excluding metastases in the abdominal region) is allowed.
9.Breast-feeding, pregnant, or likely to become pregnant during the study.
10. Other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids with the exception that low-dose corticosteroids are allowed)
11.Known hypersensitivity to a monoclonal antibody or biologic therapy.
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
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) | 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 | 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 | 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) | 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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
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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When 110 events (deaths) have been observed or after a minimum of 9 months from the date of randomization of the last subject, whichever is later. |
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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 | 0 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |