E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
metastatic pancreatic adenocarcinoma |
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E.1.1.1 | Medical condition in easily understood language |
metastatic pancreatic adenocarcinoma |
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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 | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Objective response rate of Capecitabine + Nab-Paclitaxel as first-line chemotherapy in patients with metastatic pancreatic cancer |
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E.2.2 | Secondary objectives of the trial |
Disease control rate, progression-free and overall survival, assessment of the safety & tolerability of this combination in mPC patients, evaluation of feasibility of an intra-individual dose escalation Nab-Paclitaxel dose regimen |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with histologically or cytologically confirmed metastatic pancreatic adenocarcinoma - Radiologically determinable disease defined by RECIST version 1.1 within 4 weeks prior to study treatment initiation - ECOG performance status of 0 or 1 - Adequate hematologic function, as follows - Adequate renal function - Adequate hepatic function - Any age ≥ 18 ≤ 75 years - Life expectancy > 3 months at baseline - Informed consent signed prior to any study specific procedure - Ability to comply with the protocol and attended follow up - Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to study drug administration. |
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E.4 | Principal exclusion criteria |
- Major surgery within 4 weeks prior start of study treatment - Any past or current history of other invasive malignancies less than 5 years prior to study inclusion - Clinical suspicion of brain metastases - Patient has only locally advanced disease - Patients may not have received previous treatment for metastatic or locally advanced, non- or borderline resectable disease. Prior adjuvant treatment with Gemcitabine is allowed,though tumor recurrence must have occurred ≥ 6 months after the last treatment. - Active infection requiring systemic treatment or any uncontrolled infections < 14 days prior to treatment initiation - Concurrent participation in other clinical trials - Pregnancy, lactation, patients (and patients with partners) of childbearing potential not willing to use effective means of contraception until six months after completion of study treatment - Any known hypersensitivity/allergic reaction to any of the components of study treatments - History of connective tissue disorders (eg, lupus, scleroderma, ateritis nodosa). - Patient with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies - Any severe and/or uncontrolled medical conditions including but not limited to: o Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 12 months prior to enrolment, serious uncontrolled cardiac arrhythmia o Acute and chronic, active infectious disorders and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy o Active skin, mucosa, ocular or GI disorders of grade > 1 o Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or IMP administration, or which, in the judgment of the investigator, would make the patient inappropriate for enrolment into this study |
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E.5 End points |
E.5.1 | Primary end point(s) |
Objective tumor response based on computed tomography (CT) scans (or magnetic resonance imaging [MRI] scans, if patient is allergic to contrast agent or has some other contraindication to a CT scan). These will be evaluated according to the RECIST guidelines. Interpretation of radiological response will be completed by review of CT (or MRI) scans at an independent, centralized, blinded facility. |
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E.5.2 | Secondary end point(s) |
Disease control rate (i.e., objective tumor response or stable disease for ≥16 weeks) - Progression-free survival (PFS) as time from initiation of chemotherapeutic treatment until disease progression - Overall survival (OS) as time from initiation of chemotherapeutic treatment to death from any cause - Occurrence of treatment related toxicities - Evaluation of feasibility of an intra-individual dose escalation Nab-Paclitaxel dose regimen |
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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) | 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 | 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.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
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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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |