E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Locally advanced pancreatic adenocarcinoma without distant metastases, according to the Dutch Pancreatic Cancer Group (DPCG) definition. |
|
E.1.1.1 | Medical condition in easily understood language |
Unresectable pancreatic cancer without metastases. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
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 investigate disease control after nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer. |
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E.2.2 | Secondary objectives of the trial |
To investigate toxicity, progression-free survival, overall survival, tumor marker response, resection rate and quality of life after nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Written informed consent according to ICH/GCP, and national/local regulations prior to any screening procedures.
•Histological or cytological confirmed diagnosis of pancreatic ductal adenocarcinoma.
•Locally advanced pancreatic cancer according to DPCG criteria (SMA, celiac axis or CHA contact >90° or SMV-PV contact <270° or occlusion) 28
•ECOG (WHO) performance status 0-2
•Age ≥ 18 years
•Adequate bone marrow and organ function as defined by the following laboratory values:
• Absolute neutrophil count (ANC) ≥ 1.5 *109 / L
• Hemoglobin (Hb) ≥ 9.0 g/dL (5.6 mmol/L)
• Platelets ≥ 100 *109/L
• Serum total bilirubin within ≤ 1.5 x ULN (upper limit of normal); or total bilirubin < 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert’s syndrome.
• Creatinine clearance > 50 ml / min / 1.73 m2
• AST and ALT < 2.5 ULN
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E.4 | Principal exclusion criteria |
•WHO performance status ≥ 3
•Distant metastases on abdominal or thoracic CT scan.*
•Previous surgical, local ablative, chemotherapy or radiotherapy for pancreatic cancer except for a surgical exploration with no options for resection.
• Pregnancy
•Patients who in the investigators’ opinion may be unwilling, unable or unlikely to comply with requirements of the study protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
Disease control: The percentage of patients who had a complete response, partial response, or stable disease according to RECIST 1.1 measured after 2 cycles of nab-paclitaxel plus gemcitabine and confirmed at restaging after 4 cycles of nab-paclitaxel plus gemcitabine. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 2 cycles of nab-paclitaxel plus gemcitabine and after 4 cycles: 2 months and 4 months respectively. |
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E.5.2 | Secondary end point(s) |
Toxicity according to the NCI CTC Version 4.0 grading system
Median overall survival
Progression free survival
CA19-9 and CEA response
Resection rate and margin-free resection
Quality of life |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Follow-up: 1, 3, 6, 9, 12 months. |
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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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 | 14 |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
|
The last visit follow-up 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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |