Clinical Trials Register

Summary
EudraCT Number:	2019-000616-28
Sponsor's Protocol Code Number:	AGMT_DISCOVER
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-11-20
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2019-000616-28

A.3

Full title of the trial

Multicenter, randomized, double-blind, placebo-controlled, phase III
clinical trial to investigate the efficacy and safety of Dronabinol in the
Improvement of ChemOthErapy-induced and tumor-Related symptoms in
patients with locally advanced or metastatic pancreatic cancer during firstline chemotherapy (DIsCOvER)

Multizentrische, randomisierte, doppel-blinde, Placebo kontrollierte Phase
III Studie zur Untersuchung der Wirksamkeit und Sicherheit von
Dronabinol bei der Besserung von Chemotherapie- und Tumor-bedingten
Symptomen bei Patienten mit lokal fortgeschrittenem oder metastasiertem
Pankreaskarzinom während der Erstlinientherapie (DIsCOVer)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

Studie zur Untersuchung der Wirksamkeit und Sicherheit von Dronabinol
bei der Besserung von Chemotherapie- und Tumor-bedingten Symptomen
bei Patienten mit lokal fortgeschrittenem oder metastasiertem
Pankreaskarzinom während der Erstlinientherapie

A.4.1

Sponsor's protocol code number

AGMT_DISCOVER

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03984214

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AGMT gGmbH
B.1.3.4	Country	Austria
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bionorica SE
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AGMT gGmbH
B.5.2	Functional name of contact point	Clinical Trial Lead Manager
B.5.3	Address:
B.5.3.1	Street Address	Wolfsgartenweg 31
B.5.3.2	Town/ city	Salzburg
B.5.3.3	Post code	5020
B.5.3.4	Country	Austria
B.5.4	Telephone number	+436626404411
B.5.5	Fax number	+436626404414
B.5.6	E-mail	d.wolkersdorfer@agmt.at

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	BX-1
D.3.4	Pharmaceutical form	Oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Dronabinol
D.3.9.1	CAS number	1972-08-3
D.3.9.2	Current sponsor code	BX-1
D.3.9.4	EV Substance Code	SUB06407MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	THC isolate >= 95.0% with an herbal drug: Cannabis flos, totum, as the starting material.

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Oral solution
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Advanced pancreatic (locally advanced, imoperable or metastatic) cancer
during first-line chemotherapy

Lokal fortgeschrittenes, inoperables oder metastasiertes
Pankreaskarzinom während der Erstlinientherapie

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

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)

E.1.3

Condition being studied is a rare disease

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).

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)

E.2.3

Trial contains a sub-study

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.

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 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

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).

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

E.5.2

Secondary end point(s)

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

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

104

F.4.2.2

In the whole clinical trial

104

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-03-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-09

P. End of Trial
P.	End of Trial Status	Ongoing

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