E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Unresectable Locally Advanced or Metastatic Pancreatic Adenocarcinoma |
|
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 | 10033599 |
E.1.2 | Term | Pancreatic adenocarcinoma metastatic |
|
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 |
Evaluate progression-free survival (PFS) in patients receiving ARQ 197 versus gemcitabine. |
|
E.2.2 | Secondary objectives of the trial |
• Evaluate overall response rate (ORR) in patients receiving ARQ 197 versus gemcitabine. • Evaluate 6-month and 1-year overall survival (OS) rates in patients treated with ARQ197 versus gemcitabine. • Further characterize the safety profile of ARQ 197. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Each patient must meet the following criteria to be enrolled in this study. 1. Able to provide signed and dated informed consent prior to study-specific screening procedures 2. ≥ 18 years old 3. Histologically or cytologically confirmed locally advanced or metastatic unresectable pancreatic adenocarcinoma 4. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST, see Section 9) 5. Karnofsky performance status (KPS) ≥ 70% (see Appendix 2) 6. Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment 7. Females of childbearing potential must have a negative serum pregnancy test 8. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 × ULN with metastatic liver disease 9. Hemoglobin ≥ 10 g/dl 10. Total bilirubin ≤ 1.5 × ULN 11. Serum creatinine ≤ 1.5 × ULN 12. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L 13. Platelets ≥ 100 x 109/L
|
|
E.4 | Principal exclusion criteria |
Patients who meet any of the following criteria will be excluded from the study. 1. Received any prior therapy for the treatment of their pancreatic malignancy (including chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational) 2. Central nervous system metastases 3. Pregnant or breastfeeding 4. Significant gastrointestinal disorder, in the opinion of the Principal Investigator (e.g. Crohn’s disease, ulcerative colitis, extensive gastric resection) 5. Unable or unwilling to swallow ARQ 197 capsules twice daily 6. Other cancer within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin 7. Significant co-morbid conditions that in the opinion of the Investigator would impair study participation 8. Known human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Progression of the disease |
|
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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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 | 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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
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 |
|
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
| |
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 |