Clinical Trials Register

Summary
EudraCT Number:	2016-002735-16
Sponsor's Protocol Code Number:	ABI-STAR-2016
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:	2016-10-04
Trial results	View 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

2016-002735-16

A.3

Full title of the trial

Correlation between common clinical outcome parameters, CTC-changes and ARV7-status (androgen receptor splice variant 7) in patients with mCRPC treated with first line abiraterone acetat (Zytiga®)

Korrelation zwischen gebräuchlichen klinischen Ergebnis-Parametern (rPFS, OS), CTC-Änderungen und AR-V7-Status (Androgenrezeptor-Splice-Variante 7) bei Patienten mit mCRPC unter Erstlinientherapie mit Abirateronacetat (Zytiga®)

A.3.1

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

Correlation between common clinical outcome parameters, CTC-changes and ARV7-status (androgen receptor splice variant 7) in patients with mCRPC treated with first line abiraterone acetat (Zytiga®)

A.3.2

Name or abbreviated title of the trial where available

STAR-V7

A.4.1

Sponsor's protocol code number

ABI-STAR-2016

A.5.4

Other Identifiers

Name:

Short title

Number:

STAR-V7

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	Otto-von-Guericke-Universität Magdeburg
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	Jannsen-Cilag GmbH Neuss
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	Universitätsklinik für Urologie
B.5.2	Functional name of contact point	Prof. Dr. Martin Schostak
B.5.3	Address:
B.5.3.1	Street Address	Leipziger Str. 44
B.5.3.2	Town/ city	Magdeburg
B.5.3.3	Post code	39120
B.5.3.4	Country	Germany
B.5.4	Telephone number	+493916715036
B.5.5	Fax number	+493916715094
B.5.6	E-mail	martin.schostak@med.ovgu.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	Zytiga
D.2.1.1.2	Name of the Marketing Authorisation holder	Jannsen-Cilag 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Abiraterone Acetate
D.3.9.1	CAS number	154229-18-2
D.3.9.3	Other descriptive name	ABIRATERONE ACETATE
D.3.9.4	EV Substance Code	SUB31647
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	250
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.IMP: 2
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	Zytiga
D.2.1.1.2	Name of the Marketing Authorisation holder	Jannsen-Cilag 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Abiraterone acetate
D.3.9.1	CAS number	154229-18-2
D.3.9.3	Other descriptive name	ABIRATERONE ACETATE
D.3.9.4	EV Substance Code	SUB31647
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
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.IMP: 3
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	Zytiga
D.2.1.1.2	Name of the Marketing Authorisation holder	Jannsen-Cilag 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Abiraterone acetate
D.3.9.1	CAS number	154229-18-2
D.3.9.3	Other descriptive name	ABIRATERONE ACETATE
D.3.9.4	EV Substance Code	SUB31647
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
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

metastatic castration-resistant prostate carcinoma

metastasiertes, kastrationsresistentes Prostatakarzinom

E.1.1.1

Medical condition in easily understood language

metastatic, castration-resistant prostate cancer

metastasierter, kastrationsresistenter Prostatakrebs

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

Assessment of the impact of the AR-V7-status and the number of circulating tumor cells (CTCs) to the baseline assessment on the radiologic progression free survival (rPFS) in patients with mCRPC under first line therapy with Zytiga®.

Untersuchung des Einflusses des AR-V7-Status und der Anzahl zirkulierender Tumorzellen (CTCs) zur Baseline-Untersuchung auf das radiologisch progressionsfreie Überleben (rPFS) bei Patienten mit mCRPC unter Erstlinientherapie mit Zytiga®.

E.2.2

Secondary objectives of the trial

1. Assessment of the frequency of circulating tumor cells (CTC) in patients with mCRPC under first line therapy with Zytiga®
2. AR-V7- conversion rate under first line therapy with Zytiga®
3. OS with mCRPC under first line therapy with Zytiga®
4. Correlation of PSA, CTCs and AR-V7-status with rPFS and OS under first line therapy with Zytiga®
5. Prognostic value of CTCs and AR-V7-status to the week 12 visit for rPFS and OS
6. Assessment of the life quality of the patients

1. Untersuchung der Häufigkeit zirkulierender Tumorzellen (CTCs) bei Patienten mit mCRPC unter Erstlinientherapie mit Zytiga®
2. AR-V7- Konversionsrate unter Erstlinientherapie mit Zytiga®
3. OS bei mCRPC unter Erstlinientherapie mit Zytiga®
4. Korrelation von PSA, CTCs und AR-V7-Status zu rPFS und OS unter Erstlinientherapie mit Zytiga®
5. Prognostischer Wert von CTCs und AR-V7-Status zur 12-Wochen-Visite für rPFS und OS
6. Untersuchung der Lebensqualität der Patienten

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed informed consent
2. Age ≥ 18 years
3. Patients with metastasic castration-resistant prostate carcinoma (mCRPC) ≤ 3 months, for whom a therapy decision is due
4. ≥ 5 Bone metastases in bone scintigraphy and/or visceral metastases in CT and/or MRT and/or PSMA-PET/CT (≤ 8 weeks) and/or patients with only non-regional lymph node metastases (outside the small pelvis), if at least 5 metastases with an extent of 5 cm each or extensive lymph node conglomerates are present here
5. No or mild pain symptoms
6. ECOG 0-1
7. Tumor progression under hormone therapy with LHRH-agonists/antagonists or maximum androgen blockade (MAB), respectively
8. Tumor progression: three times PSA increase (after stopping antiandrogens with previous MAB and no therapy with bicalutamide and flutamide in the last 4-6 weeks, time between measurements one week each, at least 25% increase of PSA, Basic value > 1ng/ml) and/or increase of metastases (in lymph nodes and/or bones and/or visceral organs) in the images (CT and/or MRT and/or bone scan and/or PSMA-PET/CT)referred to the last documented time
9. Testosteron in the castration area (≤ 0.2 ng/ml)
10. Palliative radiation and/or bone surgery must be at least 4 weeks ago
11. Minimal baseline CTC value ≥ 2

1. Studienteilnehmer müssen vor Beginn von studienspezifischen Maßnahmen eine unterzeichnete und mit Datum versehende Einwilligungserklärung vorlegen und willens sein, der Behandlung und den Follow-Up Untersuchungen nachzukommen. Ergebnisse von Untersuchungen, die im Rahmen von Routineuntersuchungen vor der Einwilligung erhoben wurden (z.B. bildgebende Verfahren), dürfen für das Screening und die Baseline verwendet werden, wenn sie wie im Protokoll spezifiziert durchgeführt wurden.
2. Alter ≥ 18 Jahre
3. Patienten mit metastasiertem kastrationsresistentem Prostatakarzinom (mCRPC)
4. ≥ 5 Knochenmetastasen im Knochenszintigramm und/oder viszerale Metastasen im CT und/oder MRT und/oder PSMA-PET/CT (≤ 8 Wochen) und/oder Patienten mit alleinigen nicht regionalen Lymphknotenmetastasen (außerhalb des kleinen Beckens), wenn hier mindestens 5 Metastasen mit einer Ausdehnung von jeweils 5 cm bzw. ausgedehnte Lymphknotenkonglomerate vorliegen
5. keine oder milde Schmerzsymptomatik
6. ECOG 0-1
7. Tumorprogress unter Hormontherapie mit LHRH-Agonisten/ Antagonisten bzw. maximaler Androgenblockade (MAB)
8. Tumorprogress: dreimaliger PSA Anstieg (ggf. nach Absetzen des Antiandrogens bei vorheriger MAB und 4- bis 6wöchiger Therapiefreiheit von Bicalutamid und Flutamid, Abstand der Messungen je 1 Woche, jeweils mindestens 25%iger Anstieg des PSA, Ausgangswert > 1ng/ml) und/oder Zunahme der Metastasen (in Lymphknoten und/oder Knochen und /oder viszeralen Organen) in der Bildgebung(CT und/oder MRT und/oder Knochenszintigramm und/oder PSMA-PET/CT) , bezogen auf den letzten erhobenen Zeitpunkt
9. Testosteron im Kastrationsbereich (≤ 0.2 ng/ml)
10. Palliative Radiatio und/oder Knochenchirurgie muss mindestens 4 Wochen zurückliegen
11. Minimaler baseline CTC-Wert ≥ 2

E.4

Principal exclusion criteria

1. Brain metastases
2. Severe liver impairment (ALT und AST >50% ULN); child Pugh class C
3. Severe neurological diseases
4. Previous therapy with androgenreceptor-targeted substances like Abirateron and Enzalutamid,
5. Hypersensitivity against the active compound or one of the other components listed in section 6.1 of the expert Information of Zytiga®
6. Participation in another clinical trial in the last 4 weeks

1. Hirnmetastasen
2. starke Leberfunktionseinschränkung (ALT und AST >50% ULN); Child Pugh-Klasse C
3. schwere neurologische Erkrankungen
4. Vortherapie mit androgenrezeptorgezielten Substanzen wie Abirateron und Enzalutamid
5. Überempfindlichkeit gegen den Wirkstoff oder einen der in Abschnitt 6.1. genannten sonstigen Bestandteile aus der Fachinformation zu Zytiga®
6. Teilnahme an einer anderen klinischen Studie in den letzten 4 Wochen

E.5 End points

E.5.1

Primary end point(s)

Radiologic progression-free survival under tehrapy with Zytiga® as first lien therapy with consideration of the AR-V7-status and the number of CTCs.

Radiologische progressionfreie Überlebenszeit unter Therapie mit Zytiga® als Erstlinientherapie unter Berücksichtigung des AR-V7-Status und der Anzahl an CTCs.

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline, Week 12 ± 1 Week and at progression

Baseline, Woche 12 ± 1 Woche und bei Progression

E.5.2

Secondary end point(s)

1. Number of CTCs at three time points: baseline prior to therapy start with Zytiga®, after 12 weeks ± 1 week therapy with Zytiga® and at radiologic progression
2. AR-V7-status at three time points: baseline prior to therapy start with Zytiga®, after 12 weeks ± 1 week therapy with Zytiga® and at radiologic progression
3. PSA development under first line therapy with Zytiga®
4. OS under first line therapy with Zytiga®
5. Life Quality:
- pain scale: VAS/NRS
- FACT-P, Functional Assessment of Cancer Therapy-Prostate
- QLQ-C30
- EORTC Quality of Life Questionnaire-Cancer
6. Documentation of toxicities

1. Zahl der CTCs bei mCRPC zu drei Zeitpunkten: Basis vor Therapiestart mit Zytiga®, nach 12 Wochen ± 1 Woche Therapie mit Zytiga® und bei radiologischer Progression
2. AR-V7-Status bei mCRPC zu drei Zeitpunkten: Basis vor Therapiestart mit Zytiga®, nach 12 Wochen ± 1 Woche Therapie mit Zytiga® und bei radiologischer Progression
3. PSA-Verlauf unter Zytiga® als Erstlinientherapie
4. OS unter Zytiga® als Erstlinientherapie
5. Lebensqualität:
- Schmerzskala: VAS/NRS
- FACT-P, Functional Assessment of Cancer Therapy-Prostate
- QLQ-C30,
- BFI, Brief Fatigue Inventory
- EORTC Quality of Life Questionnaire-Cancer
6. Erfassung der Toxizität

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline, Week 12 ± 1 Week and at progression

Baseline, Woche 12 ± 1 Woche und bei Progression

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

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

Last Patient Last Visit (LPLV)

LPLV

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:

140

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

200

F.2 Gender

F.2.1

Female

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

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

340

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)

Further treatment of patients who completed the study therapy will be according to the medical standard.

Die weitere Behandlung von Patienten, die die Studienbehandlung abgeschlossen haben, richtet sich nach dem medizinischen Standard.

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

2016-12-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-11-29

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2018-08-30

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