Clinical Trials Register

Summary
EudraCT Number:	2019-003770-85
Sponsor's Protocol Code Number:	DKFZ-2019-007
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2020-06-29
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

2019-003770-85

A.3

Full title of the trial

Effect of low-dose acetylsalicylic acid on early detection of advanced colorectal neoplasms

Mit ASS Darmtumore früher erkennen 2

A.3.1

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

Detect colon cancer earlier with ASA 2

Mit ASS Darmtumore früher erkennen 2

A.3.2

Name or abbreviated title of the trial where available

ASTER 2

A.4.1

Sponsor's protocol code number

DKFZ-2019-007

A.5.4

Other Identifiers

Name:

Deutsches Register Klinischer Studien (DRKS)

Number:

DRKS00020940

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	German Cancer Research Center (DKFZ)
B.1.3.4	Country	Germany
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	Deutsche Krebshilfe (German Cancer Aid)
B.4.2	Country	Germany
B.4.1	Name of organisation providing support	German Cancer Research Center (DKFZ)
B.4.2	Country	Germany
B.4.1	Name of organisation providing support	MAST Diagnostica GmbH
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	German Cancer Research Center (DFKZ)
B.5.2	Functional name of contact point	Clinical Trial Office
B.5.3	Address:
B.5.3.1	Street Address	Im Neuenheimer Feld 280
B.5.3.2	Town/ city	Heidelberg
B.5.3.3	Post code	69120
B.5.3.4	Country	Germany
B.5.6	E-mail	cto@dkfz-heidelberg.de

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	Yes
D.2.1.1.1	Trade name	ASS-ratiopharm® 100 mg TAH Tabletten
D.2.1.1.2	Name of the Marketing Authorisation holder	ratiopharm GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
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	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Screening for advanced colorectal neoplasms.

Male individuals aged 40 to 79 years scheduled for screening colonscopy and no use of acetylsalicylic acid (or other drugs with an effect on the blood coagulation system).

Screening auf fortgeschrittene kolorektale Neoplasien.

Männliche Personen im Alter von 40 bis 79 Jahren, bei denen eine Screening-Koloskopie geplant ist und die keine Acetylsalicylsäure (oder anderen Medikamenten mit Auswirkungen auf das Blutgerinnungssystem) einnehmen.

E.1.1.1

Medical condition in easily understood language

Screening for colon cancer.

Male individuals aged 40 to 79 years scheduled for screening colonscopy and no use of blood thinning medicines.

Darmkrebs-Vorsorge.
Männliche Personen im Alter von 40 bis 79 Jahren, bei denen eine Darmspiegelung geplant ist und die keine blutverdünnenden Medikamente einnehmen.

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Effect of three days of repeated intake of 100 mg acetylsalicylic acid (ASA, cumulative dose of 3 x 100 mg) on sensitivity for early detection of advanced colorectal neoplasm (defined as CRC, advanced adenoma or sessile serrated polyp/adenoma ≥ 1 cm), measured via a fecal immunochemical test (OC-Sensor) at the predefined cutoff level of 10.0 µg hemoglobin/g feces.

E.2.2

Secondary objectives of the trial

- Effect of repeated intake 100 mg ASA on sensitivity for detection of advanced colorectal neoplasm after different durations of intake and cumulative doses of ASA (200 mg, 300 mg, 400 mg, respectively).
- Effect of repeated intake of 100 mg ASA on specificity and positivity rate after different durations and cumulative doses of ASA.
- Frequency and clinical relevance of bleeding at screening colonoscopy in relation to the time since the last ASA intake.
- Frequency and type of (serious) adverse events.

Tertiary objective:
- To collect additional blood and stool samples that will be used for further research outside of the study protocol

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Male
• Age 40 to 79 years
• Planned screening colonoscopy
• No history of colorectal cancer
• No regular use of any drug with an effect on the blood clotting/coagulation system
• Able to speak and understand German sufficiently to be able to give written informed consent and comply with the study requirements

E.4

Principal exclusion criteria

• No screening colonoscopy (e.g. diagnostic or surveillance colonoscopy)
• Colonoscopy due to visible blood in stool
• Colonoscopy due to positive fecal occult blood test
• History of colorectal cancer
• History of severe gastrointestinal bleeding
• Chronic inflammatory bowel disease (e.g. Crohn’s disease, colitis ulcerosa)
• Contraindication to the trial medication
• Special warnings and precautions for use to the trial medication
• Recent use of any drug with an effect on the blood clotting/coagulation system
• Intention to use any drug that interacts with the trial medication durign the clinical study phase
• Planned surgery/dental treatment during the study
• Participation in another clinical trial

E.5 End points

E.5.1

Primary end point(s)

Effect of three days of repeated intake of 100 mg ASA (cumulative dose of 3 x 100 mg) on sensitivity for early detection of advanced colorectal neoplasm (defined as CRC, advanced adenoma or sessile serrated polyp/adenoma ≥ 1 cm), measured via a fecal immunochemical test (OC-Sensor) at the predefined cutoff level of 10.0 µg hemoglobin/g feces.

E.5.1.1

Timepoint(s) of evaluation of this end point

For the evaluation of the primary endpoint, the collection of two stool samples (one sample before the ASA intake and one sample 3 days after the start of ASA intake (day 4, cumulative dose of 3 x 100 mg ASA; first choice) are sufficient. The collection of the baseline stool sample should not be a problem; however, the collection of the stool sample exactly three days after the start of ASA intake (day 4) might not be feasible for every study participant. If the stool sample on day 4 is missing, the stool sample of day 5 (after a cumulative intake of 400 mg ASA; second choice) or the stool sample of day 3 (after a cumulative intake of 200 mg ASA; third choice) will be used for calculation.

E.5.2

Secondary end point(s)

1) Effect of repeated intake 100 mg ASA on sensitivity for detection of advanced colorectal neoplasm after different durations of intake and cumulative doses of ASA (200 mg, 300 mg, 400 mg, respectively).
2) Effect of repeated intake of 100 mg ASA on specificity and positivity rate after different durations and cumulative doses of ASA.
3) Frequency and clinical relevance of bleeding at screening colonoscopy in relation to the time since the last ASA intake.
4) Frequency and type of (serious) adverse events.

E.5.2.1

Timepoint(s) of evaluation of this end point

1 and 2) After day 3, day 4 and day 5, respectively.
3) After screening colonoscopy.
4) After day 5.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

E.8.2.3

Other

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

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

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

Day 6, which is the first day after the last fecal sample collection will be defined as end of the trial.

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

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:

811

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

414

F.2 Gender

F.2.1

Female

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

1225

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)

No further treatment with the trial medication is needed after the end of the intervention. The study intervention is only necessary before the fecal sample collection. Afterwards for all study participants a screening colonscopy (gold standard) is planned.

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

2020-07-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-08-20

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2025-01-13

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