E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic Pancreatic Cancer. To evaluate AGS-1C4D4 administered in combination with gemcitabine as measured by the survival rate at 6 months post-randomization
Cancer de páncreas metástasico. Evaluar AGS-1C4D4 administrado en combinación con gemcitabina determinado mediante la tasa de supervivencia a los 6 meses después de la aleatorización |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate AGS-1C4D4 administered in combination with gemcitabine as measured by the survival rate at 6 months post-randomization |
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E.2.2 | Secondary objectives of the trial |
To evaluate AGS-1C4D4 administered in combination with gemcitabine on overall survival (OS) and progression-free survival (PFS)
To evaluate AGS-1C4D4 administered in combination with gemcitabine in metastatic pancreatic cancer on best tumor response (stable disease, or better per RECIST criteria), and change in level of serum tumor marker CA 19-9
To evaluate AGS-1C4D4 administered in combination with gemcitabine in those subjects with metastatic pancreatic cancer determined to express prostate stem cell antigen (PSCA) by immunohistochemistry on OS, PFS and best tumor response
To evaluate the safety of AGS-1C4D4 administered in combination with gemcitabine
To evaluate immunogenicity of AGS-1C4D4 administered in combination with gemcitabine |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion 1. Man or woman 18 years of age or older 2. Pathologically confirmed metastatic adenocarcinoma of the pancreas (AJCC Stage IV). Subjects with islet cell neoplasms are excluded 3. Non-measurable or measurable disease based on the RECIST criteria 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 5. Life expectancy of > 3 months as documented by the investigator 6. Hematologic function, as follows: a. Absolute neutrophil count (ANC)≥ 1.5 x 109/L b. Platelet count ≥ 100 x 109/L c. Hemoglobin ≥ 9 g/dL (transfusion independent) 7. Renal function, as follows: a. Creatinine ≤2.0 mg/dL
8. Hepatic function, as follows: a. Aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN if known liver metastases. b. Alanine aminotransferase (ALT) ≤ 2.5 x ULN c. Bilirubin ≤2 x ULN 9. INR <1.3 (or 3 if on warfarin for therapeutic anti-coagulation) 10. Competent to comprehend, sign, and date an independent ethics committee/institutional review board (IEC/IRB) approved informed consent form. |
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E.4 | Principal exclusion criteria |
Exclusion 1. Prior systemic therapy for metastatic pancreatic cancer (prior systemic treatment for local disease is allowed) 2. Chemotherapy and/or radiation within 4 weeks of study enrollment 3. Prior monoclonal antibody therapy within 60 days of study enrollment 4. Brain or leptomeningeal disease 5. History of other primary malignancy, unless: a. Curatively resected non-melanomatous skin cancer b. Other malignancy curatively treated with no known active disease present and no treatment administered for the last 3 years 6. Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System) 7. Use of any investigational product within 4 weeks of study enrollment 8. Major surgery (that requires general anesthesia) within 4 weeks before study enrollment 9. Women who are pregnant (confirmed by positive pregnancy test) or lactating 10. Man or woman of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for 4 weeks after the last AGS-1C4D4 and/or gemcitabine infusion administration 11. Subject known to be human immunodeficiency, hepatitis B or hepatitis C virus positive 12. Active serious infection not controlled with antibiotics 13. Subject unwilling or unable to comply with study requirements 14. Known allergy to the ingredients of the study drug or to Staphylococcus protein A 15. Any medical or psychiatric disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the subjects? survival status at 6-months, measured relative to the date of randomization. The survival status of each subject will be classified as alive or dead (irrespective of cause of death). |
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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 | 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) | 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 | 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
| 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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |