E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced pancreatic (locally advanced, inoperable or metastatic) cancer during first-line chemotherapy |
Lokal fortgeschrittenes, inoperables oder metastasiertes Pankreaskarzinom während der Erstlinientherapie |
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E.1.1.1 | Medical condition in easily understood language |
Advanced pancreatic (locally advanced, inoperable or metastatic) cancer during first-line chemotherapy |
Lokal fortgeschrittenes, inoperables oder metastasiertes Pankreaskarzinom während der Erstlinientherapie |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033604 |
E.1.2 | Term | Pancreatic cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
The primary endpoint variable is the standardized area under the curve of the EORTC QLQ-C30 symptom summary score over the on-treatment period (scores at visits 1-9). |
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E.2.2 | Secondary objectives of the trial |
1. Standardized area under the curve of the EORTC QLQ-C30 symptom summary score over the maintenance period 2. Change of EORTC QLQ-C30 symptom summary score from baseline to V9 3. Symptom scales of EORTC QLQ-C30 4. Global quality of life of the EORTC QLQ-C30 5. Functional scales of the EORTC QLQ-C30 6. Mean change from baseline of the Glasgow Prognostic Score (CRP and albumin) 7. Amount of concomitant medication taken 8. Mean time to critical weight-loss (5%) after the 16 weeks treatment period 9. Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameters 10. Mean change from baseline of muscle strength 11. Proportion of patients not adhering to individual baseline chemotherapy regime 12. Chemotherapeutic dosing and dose intensity over the treatment period 13. Frequency and severity of (serious) adverse events (S)AE 14. Incidence of adverse drug reactions (ARs) 15. Progression-free survival (PFS) 16. Overall survival (OS) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male and female subjects aged ≥18 • Patients with diagnosis of locally advanced, inoperable or metastatic pancreatic cancer, eligible for first-line chemotherapy with FOLFIRINOX or gemcitabine+Abraxane® • According to investigator life expectancy of > 4 months at screening • Female patients must either be post-menopausal or surgically sterilized or use a highly effective method of birth control (hormonal contraceptives, intra–uterine devices, or diaphragms with spermicide) for the duration of the study and/or must have a negative pregnancy test (female patients with childbearing potential only) • Willing and able to provide written informed consent. • Written informed consent given prior to any trial-related procedure not part of the normal medical practice. |
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E.4 | Principal exclusion criteria |
• Patients who are members of the staff of the trial center, staff of the sponsor or CRO, the investigator him/herself or close relatives of the investigator. • Simultaneous participation in another interventional clinical trial, participation in another trial with less than 30 days or five half-lives of the IMP (whatever is longer) to screening, or previous participation in this trial. • Ineligible for chemotherapy treatment with FOLFIRINOX or gemcitabine+Abraxane® • Use of dronabinol or cannabis-based medicine with THC as constituent within 6 months before screening. A urine drug test will be performed during screening phase. • Use of marihuana within the last 4 weeks and unwillingness to abstain for the duration of the study. A urine drug test will be performed during screening phase. • Currently receiving chemotherapy or anticipated use of chemotherapy due to any condition not related to locally advanced or metastatic pancreatic cancer • History of or existing cardiac diseases or pathological findings (e.g. chronic insufficiency NYHA III/IV, severe arrhythmia, unstable angina pectoris, myocardial infarction within the past 6 months, significant QT-prolongation etc.), which in the opinion of the investigator might interfere with the safety or tolerability of the study treatment. An ECG has to be done to exclude pathological findings and must not be older than 3 months before screening or if none is available, has to be performed during the screening phase and assessed prior to randomization • Clinically relevant, severe pulmonary diseases, uncontrolled hypertension, or poorly controlled diabetes • History of or existing relevant CNS and/or psychiatric disorders (e.g. schizophrenia, psychosis, manic and/or depressive disorders, suicidal ideations, etc) which might interfere with the safety or tolerability of the study treatment. Patients with reactive depression are not excluded from participation. • Known current or past (within the last year prior to screening) alcohol, narcotics or drug abuse • Pregnancy or breast feeding • Known allergy to cannabinoids and other constituents of the investigational medicinal product • Intake of prohibited concomitant medication • Any other substantial medical condition that in the opinion of the investigator could create undue risk to the subject or could affect adherence with the trial protocol • Legal incapacity, limited legal capacity or any other condition which makes the subject unable to understand the subject information and informed consent form (ICF) • Patients unable or unwilling to waive driving motor vehicles or using machines especially during titration period • Unable or unwilling to comply with the protocol regulations
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint variable is the standardized area under the curve of the EORTC QLQ-C30 symptom summary score over the on-treatment period (visit 1-9). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Prior to treatment start and two-weekly thereafter until end of 16 weeks of treatment |
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E.5.2 | Secondary end point(s) |
1. Standardized area under the curve of the EORTC QLQ-C30 symptom summary score over the maintenance period 2. Change of EORTC QLQ-C30 symptom summary score from baseline to V9 3. Symptom scales of EORTC QLQ-C30 4. Global quality of life of the EORTC QLQ-C30 5. Functional scales of the EORTC QLQ-C30 6. Mean change from baseline of the Glasgow Prognostic Score (CRP and albumin) 7. Amount of concomitant medication taken 8. Mean time to critical weight-loss (5%) after the 16 weeks treatment period 9. Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameters 10. Mean change from baseline of muscle strength 11. Proportion of patients not adhering to individual baseline chemotherapy regime 12. Chemotherapeutic dosing and dose intensity over the treatment period 13. Frequency and severity of (serious) adverse events (S)AE 14. Incidence of adverse drug reactions (ARs) 15. Progression-free survival (PFS) 16. Overall survival (OS) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Point 1: after end of titration period (4 weeks) 2-weekly until end of treatment at week 16 Points 2-5: at baseline and 2-weekly until end of treatment at week 16 Points 6, 9 and 10: at baseline and at end of 16-week treatment Points 7,8, 11 and 12: baseline until end of treatment (maximum of 18 weeks) Points 13-16: baseline until safety visit at week 22 |
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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 | 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 | 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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 8 |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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 | 4 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 9 |