Clinical Trials Register

Summary
EudraCT Number:	2014-004086-24
Sponsor's Protocol Code Number:	AIO-PAK-0114
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-10-08
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

2014-004086-24

A.3

Full title of the trial

Induction Treatment with nab-Paclitaxel/Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer Followed by Either Alternating Application of Gemcitabine Monotherapy and nab-Paclitaxel/Gemcitabine or Continuing Application of nab-Paclitaxel/Gemcitabine: A Randomized Phase II Study

Induktionstherapie mit nab-Paclitaxel/Gemcitabin in der Erstlinienbehandlung des metastasierten Pankreaskarzinoms gefolgt von entweder alternierender Verabreichung von Gemcitabin Monotherapie und nab-Paclitaxel/Gemcitabin oder fortlaufender Verabreichung von nab-Paclitaxel/Gemcitabin: Eine randomisierte Phase II Studie

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

ALPACA

A.4.1

Sponsor's protocol code number

AIO-PAK-0114

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	AIO-Studien-gGmbH
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	Celgene 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	AIO-Studien-gGmbH
B.5.2	Functional name of contact point	AIO-Studien-gGmbH
B.5.3	Address:
B.5.3.1	Street Address	Kuno-Fischer-Str. 8
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	14057
B.5.3.4	Country	Germany
B.5.4	Telephone number	004930322932931
B.5.5	Fax number	004930322932926
B.5.6	E-mail	info@aio-studien-ggmbb.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	Abraxane
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb Pharma EEIG
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PACLITAXEL
D.3.9.1	CAS number	33069-62-4
D.3.9.2	Current sponsor code	nab-Paclitaxel
D.3.9.4	EV Substance Code	SUB09583MIG
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	100
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	The IMP contains an excipient of biological origin, albumin, a non-active stabilizing agent. It is derived from human blood subject to approved donor screening and product manufactoring processes.
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.2.1.2	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.3.1	Product name	Gemcitabine
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GEMCITABINE
D.3.9.1	CAS number	95058-81-4
D.3.9.2	Current sponsor code	Gemcitabin
D.3.9.4	EV Substance Code	SUB07892MIG
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	38
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 pancreatic cancer

metastasiertes Pankreaskarzinom

E.1.1.1

Medical condition in easily understood language

metastatic pancreatic cancer

metastasiertes Pankreaskarzinom

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	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10033605
E.1.2	Term	Pancreatic cancer metastatic
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To estimate the treatment effect of alternating treatment cycles of gemcitabine monotherapy followed by nab-paclitaxel/gemcitabine relative to standard continuing nab-paclitaxel/gemcitabine treatment cycles in first-line treatment for metastatic pancreatic cancer in patients having recieved 3 cycles of induction therapy with standard nab-paclitaxel/gemcitabine.

Ziel ist die Abschätzung des Behandlungseffektes einer alternierenden Therapie bestehend aus Gemcitabin-Monotherapie und Nab-Paclitaxel/Gemcitabin Kombinationstherapie im Vergleich zu einer fortgesetzten Standardtherapie bestehend aus Nab-Paclitaxel/Gemcitabin in Patienten mit metastasiertem Pankreaskarzinom, welche in der Erstlinie behandelt werden und drei Zyklen Induktionstherapie entsprechend dem Standard Nab-Paclitaxel/Gemcitabin erhalten haben.

E.2.2

Secondary objectives of the trial

To estimate the treatment effect on feasibility, efficacy and safety of alternating treatment cycles of gemcitabine monotherapy followed by nab-paclitaxel/gemcitabine relative to standard continuing nab-paclitaxel/gemcitabine cycles during the randomized treatment phase.

Sekundäres Ziel ist die Abschätzung des Behandlungseffektes in Hinblick auf Machbarkeit, Wirksamkeit und Sicherheit einer alternierenden Therapie bestehend aus Gemcitabin-Monotherapie und Nab-Paclitaxel/Gemcitabin Kombinationstherapie im Vergleich zu einer fortgesetzten Standardtherapie nach Randomisierung.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Exploratory objectives:
- To exploratorily describe efficacy and safety during induction phase
- To describe efficacy and safety of all patients treated with alternating or continuing nab-paclitaxel/gemcitabine treatment cycles after randomization and all non-randomized patients with documented start of nab-paclitaxel/gemcitabine induction treatment to permit comparison with published historical data of the MPACT trial

Explorative Studienziele
- Explorative Beschreibung der Wirksamkeit und Sicherheit während der Induktionsphase
- Die Beschreibung der Wirksamkeit und Sicherheit in allen Patienten, welche mit dem alternierenden oder dem Standard-Behandlungsschema therapiert werden und aller nicht-randomisierten Patienten mit dokumentiertem Beginn einer Behandlung mit Nab-Paclitaxel/Gemcitabin Induktionsschema, um den Vergleich mit den historischen Daten der MPACT Studie zu ermöglichen.

E.3

Principal inclusion criteria

- Adult patients (≥ 18 years of age)
- Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are excluded.
- Karnofsky performance status (KPS) ≥ 70%
- At least one unidimensionally measurable lesion as assessed by CT-scan or MRI according to RECIST 1.1
- Total bilirubin ≤ 1.5 x ULN. Patients with a biliary stent may be included provided that bilirubin level after stent insertion decreased to ≤ 1.5 x ULN and there is no cholangitis.
- Adequate renal, hepatic and bone marrow function, defined as
▪ Calculated creatinine clearance ≥ 30 mL/min according to CKD-EPI formula
▪ AST/GOT and/or ALT/GPT ≤ 2.5 x ULN and ≤ 5.0 x ULN in case of liver metastasis
▪ Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
▪ Haemoglobin ≥ 9 g/dL
▪ Platelets ≥ 100 x 10^9/L
- Females of childbearing potential (FCBP) must have a negative serum pregnancy test within 7 days of the first application of study treatment and they must agree to undergo further pregnancy tests before randomization and at the end of treatment visit
and
FCBP must either agree to use and be able to take effective contraceptive birth control measures (Pearl Index < 1) or agree to practice complete abstinence from heterosexual intercourse during the course of the study and for at least 1 month after last application of study treatment.
A female subject is considered to be of childbearing potential unless she is age ≥ 50 years and naturally amenorrhoeic for ≥ 2 years, or unless she is surgically sterile.
- Males must agree not to father a child during the course of the trial and for at least 6 months after last administration of study drugs.
- Signed and dated informed consent before the start of any specific protocol procedures
- Patient’s legal capacity to consent to study participation

- Volljährige Patienten (Alter ≥ 18 Jahre)
- Histologisch oder zytologisch gesichertes metastasiertes Adenokarzinom der Pankreas. Patienten mit Inselzell-Neoplasien sind ausgeschlossen.
- Allgemeinzustand nach Karnofsky Performance Score (KPS) ≥ 70%
- Mindestens eine eindimensional nach RECIST 1.1 Kriterien messbare Läsion ermittelt durch CT-Scan oder MRT
- Gesamt-Bilirubin ≤ 1,5 x oberer Normwert. Patienten mit einem Gallengangsstent sind einschlussfähig, sofern der Bilirubin-Spiegel nach der Stent-Einlage auf ≤ 1,5 x oberer Normwert absinkt und keine Cholangitis vorliegt.
- Adäquate Nieren-, Leber- und Knochenmarkfunktion definiert als:
▪ Kreatinin-Clearance ≥ 30 ml/min berechnet nach CKD-EPI-Formel
▪ AST/GOT und/oder ALT/GPT ≤ 2,5 x oberer Normwert und ≤ 5,0 x oberer Normwert im Falle von Lebermetastasen
▪ Absolute Zahl der Neutrophilen (ANC) ≥ 1,5 x 10^9/l
▪ Hämoglobin ≥ 9 g/dl
▪ Thrombozytenzahl ≥ 100 x 10^9/l
- gebärfähige Frauen müssen in einem Zeitraum von 7 Tagen vor der ersten Anwendung der Studienbehandlung einen negativen Serum-Schwangerschaftstest haben und sie müssen sich weiteren Schwangerschaftstests vor der Randomisierung und bei der Abschlussuntersuchung unterziehen.
Weiterhin müssen gebärfähige Frauen sich während der Studie und für mindestens 1 Monat nach der letzten Gabe der Studienmedikation bereit erklären und in der Lage sein, effektive Maßnahmen zur Empfängnisverhütung (Pearl-Index <1) anzuwenden oder eine vollständige Enthaltsamkeit von heterosexuellen Geschlechtsverkehr zu praktizieren.
Eine weibliche Person ist im gebärfähigen Alter, solange sie nicht ≥ 50 Jahre alt und ≥ 2 Jahre natürlicherweise amenorrhoisch ist oder aber chirurgisch sterilisiert wurde.
- Männer müssen einverstanden sein für die Dauer der Studienteilnahme und wenigstens 6 Monate nach der letzten Gabe der Studienmedikation kein Kind zu zeugen.
- Vorliegen einer unterschriebenen und datierten Einverständniserklärung des Patienten vor Beginn jedweder protokoll-spezifischer Prozeduren.
- Geschäftsfähigkeit des Patienten

E.4

Principal exclusion criteria

- Missing histological or cytological confirmation of metastatic adenocarcinoma of the pancreas
- Locally advanced pancreatic adenocarcinoma without metastases
- Any previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. (Prior adjuvant chemotherapy with gemcitabine or fluoropyrimidine in curative intent is allowed if terminated more than 6 months before first application of study treatment. Previous palliative radiotherapy of bone metastases for alleviation of pain is permitted provided that irradiated bone metastases are no target lesions.)
- Known brain metastase/brain metastases. Brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients.
- Pre-existing polyneuropathy ≥ grade 2 according to CTCAE version 4
- Medical history of interstitial lung disease (ILD) or pulmonary fibrosis
- Patients with high cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year
- Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
- Any other severe concomitant disease or disorder, which could influence patient’s ability to participate in the study and his/her safety during the study or interfere with interpretation of study results e.g. severe hepatic, renal, pulmonary, metabolic, or psychiatric disorders
- Previous or concurrent tumor other than underlying tumor disease (pancreatic cancer) with the exception of cervical cancer in situ, adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder tumors (Ta, Tis, and T1) or any curatively treated tumors > 5 years prior to enrolment
- Hypersensitivity against nab-paclitaxel, gemcitabine, or any excipients of these drugs
- Continuing abuse of alcohol, drugs, or medical drugs
- Pregnant females, breast feeding females or females of childbearing potential unable to either perform adequate contraceptive measures or practice complete abstinence from heterosexual intercourse
- Participation in any other clinical trial or treatment with any experimental drug within 28 days before enrolment to the study or during study participation until the end of treatment visit

- Fehlende histologische oder zytologische Bestätigung des metastasierten Adenokarzinoms der Pankreas
- Lokal fortgeschrittenes Adenokarzinom des Pankreas ohne Metastasen
- Alle vorherige Strahlentherapie, Operation, Chemotherapie oder Therapie mit klinischen Prüfpräparaten zur Behandlung von metastasierten Erkrankungen. (Eine vorherige adjuvante Chemotherapie mit Gemcitabin oder Fluoropyrimidinen mit kurativer Intention ist erlaubt, sofern diese vor mehr als 6 Monaten vor der ersten Anwendung der Studienbehandlung beendet wurde. Eine vorangegangene palliative Strahlentherapie zur Schmerzlinderung von Knochenmarkmetastasen ist zulässig, vorausgesetzt der bestrahlte Bereich von Knochenmetastasen weist keine Zielläsionen auf.)
- Bekannte Hirnmetastasen. Bei symptomatischen Patienten ist die Bildgebung des Gehirns erforderlich, um Hirnmetastasen auszuschließen. Bei asymptomatischen Patienten ist diese nicht erforderlich.
- Vorbestehende Polyneuropathie ≥ Grad 2 entsprechend CTCAE Version 4.
- Bekannte interstitielle Lungenerkrankung oder Lungenfibrose
- Patienten mit hohem kardiovaskulären Risiko einschließlich aber nicht beschränkt auf kürzlich implantierte Koronarstents oder Myokardinfarkt im zurückliegenden Jahr.
- Unkontrollierte schwerwiegende Erkrankung oder medizinischer Zustand (einschließlich unkontrolliertem Diabetes mellitus)
- Jede andere schwerwiegende Begleiterkrankung oder Störung, welche die Eignung und Fähigkeit des Patienten zur Studienteilnahme bzw. die Sicherheit während der Studienteilnahme beeinträchtigt oder die Interpretation der Studienergebnisse beeinflussen könnte z.B. schwere Leber-, Nieren-, Lungen-, metabolische oder psychiatrische Erkrankungen.
- Andere vorangegangene oder gleichzeitige Tumorerkrankung als die zugrundeliegende Erkrankung Pankreaskarzinom, mit Ausnahme von Gebärmutterhalskrebs (Carcinoma in situ); adäquat behandeltes Basalzellkarzinom oder Plattenepithelkarzinom der Haut; oberflächlicher Blasentumor (Ta, Tis und T1) oder andere kurativ behandelte Tumoren > 5 Jahre vor Studieneinschluss.
- Bekannte Überempfindlichkeit gegenüber Nab-Paclitaxel, Gemcitabin oder anderen Hilfsstoffen dieser Medikamente.
- Anhaltender Alkohol-, Medikamenten- oder Drogenabusus.
- Schwangere Frauen, stillende Frauen oder potenziell gebärfähige Frauen, die nicht in der Lage sind adäquate Maßnahmen zur Empfängnisverhütung anzuwenden oder die völlige Abstinenz von heterosexuellem Geschlechtsverkehr einzuhalten.
- Teilnahme an einer anderen klinischen Studie oder einer Behandlung mit einer experimentellen Substanz innerhalb von 28 Tagen vor dem Studieneinschluss oder während der Studienteilnahme bis zur Abschlussuntersuchung.

E.5 End points

E.5.1

Primary end point(s)

Overall survival determined from the time of randomization until date of death

Gesamtüberleben gemessen ab dem Zeitpunkt der Randomisierung bis zum Tod

E.5.1.1

Timepoint(s) of evaluation of this end point

5.75 years after FPI

5.75 Jahre nach FPI

E.5.2

Secondary end point(s)

Efficacy variables:
- Progression-free survival as time from randomization to objective tumor progression or death from any cause
• Overall response rate (according to RECISTv1.1) determined from first application of induction treatment
• Disease control rate (according to RECISTv1.1) determined from first application of induction treatment
• Quality of life as determined with EORTC QLQ-C30 determined from randomization

Safety variables:
- Type, incidence, and severity of adverse events according to NCI CTCAE version 4 with explicit consideration of any neurotoxicity
- Duration of treatment without toxicity leading to permanent discontinuation
- Functional assessment of neurotoxicity (with FACT taxane score)

Wirksamkeitsvariablen:
- Progressionsfreies Überleben gemessen ab Zeitpunkt der Randomisierung bis zur objektiven Tumorprogression oder Tod (jeder Ursache)
- Generelle Ansprechrate (nach RECIST 1.1) gemessen ab erster Gabe der Induktionstherapie
- Krankheitskontrollrate (nach RECIST 1.1) gemessen ab erster Gabe der Induktionstherapie
- Lebensqualität erhoben mittels EORTC-QLQ-C30 ab Randomisierung

Sicherheitsvariablen:
- Art, Häufigkeit und Schweregrade von unerwünschten Ereignissen entsprechend NCI-CTCAE Version 4 unter besonderer Berücksichtigung jedweder Neurotoxizität
- Dauer der Behandlung ohne Toxizität, die zu einem permanenten Behandlungsabbruch führt
- Funktionelle Bewertung der Neurotoxizität anhand des FACT Taxane-Scores

E.5.2.1

Timepoint(s) of evaluation of this end point

6-8 months after FPI

6-8 Monate after FPI

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

Yes

E.6.13.1

Other scope of the trial description

Additional exploratory endpoints:
Efficacy and safety during induction phase:
- Overall response rate during induction phase
- Disease control rate during induction phase
- Overall survival during induction phase
- Progression-free survival during induction phase
- Duration of treatment during induction phase
- Type, incidence, and severity of adverse events according to NCI CTCAE version 4 with explicit consideration of any neurotoxicity during induction phase

Quality of life

Wirksamkeit und Sicherheit:
- Generelle Ansprechrate während der Induktionstherapie
- Krankheitskontrollrate während der Induktionstherapie
- Gesamtüberleben während der Induktionsphase
- Progressionsfreies Überleben während der Induktionsphase
- Dauer der Behandlung während der Induktionsphase
- Art, Häufigkeit und Schweregrade von AEs entsprechend NCI-CTCAE V4 unter besonderer Berücksichtigung jedweder Neurotoxizität während der Induktionsphase

Lebensqualität

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Gemcitabin/nab-paclitaxel Behandlung

Gemcitabine/nab-Paclitaxel treatment

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

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

End of trial and last patient last visit (LPLV) will be the last follow-up visit of the last patient having received study drug.
Planned September 2021

Ende der klinischen Prüfung und Letzter Patient letzte Visite wird die letzte Follow-up-visite des letzten Patienten, welcher Studienmedikation erhalten hat, sein.
Geplant ist September 2021

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:

325

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

325

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

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

325

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 is at the discretion of the treating physician

Die weitere Behandlung liegt im Ermessen des Arztes

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

2015-11-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-11-18

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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