Study to investigate the efficacy and safety of dronabinol in the improvement of chemotherapy-induced and tumor-related symptoms in patients with advanced pancreatic cancer during first-line chemotherapy

Phase 1

• Conditions: Advanced pancreatic (locally advanced, imoperable or metastatic) cancerduring first-line chemotherapy; MedDRA version: 21.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-000616-28-DE
• Lead Sponsor: AGMT gGmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-20
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 104

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 67

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 QTprolongation etc.), which in the opinion of the investigator might
interfere with the safety or tolerability of the study treatment
• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified