Efficacy and Safety of Dronabinol in the Improvement of Chemotherapy-induced and Tumor-related Symptoms in Advanced Pancreatic Cancer

Inclusion Criteria:

• Male and female subjects aged ≥18

• Patients with diagnosis of locally advanced, inoperable or metastatic pancreaticcancer, eligible for first-line chemotherapy with FOLFIRINOX orgemcitabine+Abraxane®

• According to investigator life expectancy of > 4 months at screening

• Female patients must either be post-menopausal or surgically sterilized or use ahighly effective method of birth control (hormonal contraceptives, intra-uterinedevices, or diaphragms with spermicide) for the duration of the study and/or musthave 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 thenormal medical practice.

Exclusion Criteria:

• Patients who are members of the staff of the trial center, staff of the sponsor orCRO, the investigator him/herself or close relatives of the investigator.

• Simultaneous participation in another interventional clinical trial, participationin another trial with less than 30 days or five half-lives of the IMP (whatever islonger) 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 monthsbefore screening. A urine drug test will be performed during screening phase.

• Use of marihuana within the last 4 weeks and unwillingness to abstain for theduration of the study. A urine drug test will be performed during screening phase.

• Currently receiving chemotherapy or anticipated use of chemotherapy due to anycondition not related to locally advanced or metastatic pancreatic cancer

• History of or existing cardiac diseases or pathological findings (e.g. chronicinsufficiency NYHA III/IV, severe arrhythmia, unstable angina pectoris, myocardialinfarction within the past 6 months, significant QT-prolongation etc.), which in theopinion of the investigator might interfere with the safety or tolerability of thestudy treatment. An ECG has to be done to exclude pathological findings and must notbe older than 3 months before screening or if none is available, has to be performedduring the screening phase and assessed prior to randomization

• Clinically relevant, severe pulmonary diseases, uncontrolled hypertension, or poorlycontrolled 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, narcoticsor drug abuse

• Pregnancy or breast feeding

• Known allergy to cannabinoids and other constituents of the investigationalmedicinal product

• Intake of prohibited concomitant medication

• Any other substantial medical condition that in the opinion of the investigatorcould create undue risk to the subject or could affect adherence with the trialprotocol

• Legal incapacity, limited legal capacity or any other condition which makes thesubject unable to understand the subject information and informed consent form (ICF)

• Patients unable or unwilling to waive driving motor vehicles or using machinesespecially during titration period

• Unable or unwilling to comply with the protocol regulations