Clinical Trials Register

Summary
EudraCT Number:	2006-000914-19
Sponsor's Protocol Code Number:	EPO-ANE-4008
National Competent Authority:	Slovakia - SIDC (Slovak)
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2006-08-10
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Slovakia - SIDC (Slovak)

A.2

EudraCT number

2006-000914-19

A.3

Full title of the trial

A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia.

A.4.1

Sponsor's protocol code number

EPO-ANE-4008

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Johnson & Johnson Pharmaceutical Research & Development
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	EPREX 10,000 IU/ml solution for injection
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Cilag International N.V.
D.2.1.2	Country which granted the Marketing Authorisation	Solomon Islands
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	EPOETIN ALFA/ 10.000 IU/ml
D.3.2	Product code	EPO
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	glycoprotein
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	EPREX 40,000 IU/ml solution for injection
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Cilag International N.V.
D.2.1.2	Country which granted the Marketing Authorisation	Slovakia
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	EPOETIN ALFA/ 40.000 IU/ml
D.3.2	Product code	EPO
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	glycoprotein
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	EPREX 4,000 IU/ml solution for injection
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Cilag International N.V.
D.2.1.2	Country which granted the Marketing Authorisation	Slovakia
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	EPOETIN ALFA/ 4.000 IU/ml
D.3.2	Product code	EPO
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	glycoprotein

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

Anemia in cancer patients receiving chemotherapy

MedDRA Version 5.1 : list of preferred terma used in the process of defining thrombotic vascular events, see investigators brochure epoetin alpha.

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

The primary objective is to compare the safety with respect to the incidence of clinically relevant and objectively confirmed TVEs in 2 dosing regimens of epoetin alfa when used following guidelines for baseline Hb (<=11 g/dL) and target Hb ( 12 g/dL) to treat anemia in subjects with nonmyeloid malignancies who are receiving chemotherapy.

E.2.2

Secondary objectives of the trial

Seconday efficacy objectives include assessment of change in Hb, proportion of responders to epoetin alfa, and red blood cell (RBC) transfusion. Secondary safety objectives include rate of rise in Hb, time to clinically relevant and objectively confirmed TVE, and time to death. Overall safey including adverse events and clinical laboratory values will also be assessed.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

" Men or women, 18 years of age or older
" Any histologically confirmed nonmyeloid tumor at initial diagnosis
" Day 1 baseline Hb d11 g/dL
" Expected to receive at least 12 weeks of chemotherapy after enrollment
into the study. For subjects receiving cyclic chemotherapy,
randomization must be on the first day of a chemotherapy cycle. For
subjects receiving non-cyclic chemotherapy, randomization may occur at
any time during the chemotherapy.
" ECOG performance status d2 (Attachment 3)
" Life expectancy of >6 months, based on the clinical judgment of the
investigator
" Normal neutrophil count (>1.5 x 109/L) at start of initial chemotherapy
" Normal platelet count (>100 x 109/L) at start of initial chemotherapy
" Serum creatinine and bilirubin <1.5 times the upper limit of normal
(ULN); aspartate aminotransferase (AST), alanine aminotransferase
(ALT), alkaline phosphatase <3 times the ULN
" TSAT e20%
" Female subjects must be postmenopausal (for at least 1 year), surgically
sterile, abstinent, or, if sexually active, be practicing an effective method
of birth control (e.g., prescription oral contraceptives, contraceptive
injections, intrauterine device, double-barrier method, contraceptive
patch, male partner sterilization) before randomization; have a negative
serum beta-human chorionic gonadotropin (²-hCG) pregnancy test
within 2 weeks before randomization; and a negative urine pregnancy
test at randomization.
" Subjects (or their legally acceptable representatives) must have signed
an informed consent document indicating that they understand the
purpose of and procedures required for the study and are willing to
participate in the study.

E.4

Principal exclusion criteria

" History of active second cancer except for adequately treated skin cancer
and in situ cervical cancer
" History of DVT or PE within 12 months before study entry or at any
time if the event is related to the current cancer, which is defined as
diagnosis of the cancer within 3 months of a DVT/PE episode or a
DVT/PE following the cancer diagnosis/treatment. Prior superficial
thrombophlebitis is not an exclusion criterion.
" History of CVA, TIA, ACS, or other arterial thrombosis within 6 months
before study entry. ACS includes unstable angina, QwMI, and NQMI
" Onset of seizures within 3 months before randomization or poorly
controlled seizures
" Brain tumor or brain metastasis from another malignancy
" Evidence of ischemic heart disease, New York Heart Association
(NYHA) Class 3 to 4 cardiac disease (Attachment 4) or significant
arrhythmias
" Uncontrolled hypertension (systolic >180 mmHg, diastolic >100 mmHg)
while receiving antihypertensive therapy or not on therapy
" Anemia secondary to vitamin B12, folic acid, or iron deficiency
" Anemia known to be secondary to gastrointestinal bleed, hemolysis
(acquired or hereditary, e.g., sickle cell syndrome, thalassemia
syndrome), PRCA, or primary myelodysplastic syndrome
" Presence of other comorbid conditions or illnesses of the cardiovascular,
respiratory, renal, or other body systems that would preclude
administration of planned chemotherapy
" Previous therapy with any marketed epoetin product within 2 months
before randomization, lack of response to prior therapy with any epoetin
product, or use of any investigational epoetin product at any time
" Major surgery within 4 weeks before randomization or any preplanned
surgery during the study
" Current treatment with therapeutic or prophylactic anticoagulants. The
only exceptions are low dose aspirin (d325 mg/d) in subjects with
known cardiovascular disease or low dose anticoagulants to maintain
patency of intravenous lines
" Planned myeloablative chemotherapy with stem cell rescue or bone
marrow transplant
" Have received an experimental drug or used an experimental medical
device within 3 months before the planned start of treatment.
" Is pregnant or breast-feeding
" Known hypersensitivity to epoetin alfa, or mammalian-cell derived
products or formulation excipients
" Employees of the investigator or study center, with direct involvement in
the proposed study or other studies under the direction of that
investigator or study center, as well as family members of the employees
or the investigator.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the proportion of subjects with at least 1 clinically
relevant and objectively confirmed TVE from randomization through
Week 16.

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

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

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

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

another dosing regimen of epoetin alfa

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

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

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	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	80
F.4.2	For a multinational trial
F.4.2.1	In the EEA	412
F.4.2.2	In the whole clinical trial	500

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

2007-03-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-03-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2009-09-10

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials