Clinical Trials Register

Summary
EudraCT Number:	2016-000971-26
Sponsor's Protocol Code Number:	RHF-CAELYX-002
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2016-04-04
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

Czechia - SUKL

A.2

EudraCT number

2016-000971-26

A.3

Full title of the trial

Liposoms (drug delivery systems) in kinetically guided therapy of ovarian platinum-resistant carcinoma with doxorubicin using plasmafiltration

Lipozomy (drug delivery systems) v kineticky řízené léčbě platinarezistentního karcinomu ovarií doxorubicinem pomocí plazmafiltrace

A.3.1

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

Therapy of ovarian carcinoma with doxorubicin using plasmafiltration

Léčba karcinomu ovarií doxorubicinem pomocí plazmafiltrací

A.3.2

Name or abbreviated title of the trial where available

Kinetically therapy of ovarian platinum-resistant carcinoma with doxorubicin using plasmafiltration

Kineticky řízená léčba platinarezistentního karcinomu ovarií doxorubicinem pomocí plazmafiltrace

A.4.1

Sponsor's protocol code number

RHF-CAELYX-002

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	Charles University in Prague, Medical Faculty
B.1.3.4	Country	Czech Republic
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	Charles University in Prague, Medical Faculty in Hradec Králové
B.4.2	Country	Czech Republic
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Charle University in Prague, Medical Faculty
B.5.2	Functional name of contact point	Medical Faculty in Hradec Králové
B.5.3	Address:
B.5.3.1	Street Address	Šimkova 870
B.5.3.2	Town/ city	Hradec Králové
B.5.3.3	Post code	50038
B.5.3.4	Country	Czech Republic
B.5.4	Telephone number	+420495816136
B.5.5	Fax number	+420495816136
B.5.6	E-mail	granty@lfhk.cuni.cz

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	CAELYX
D.2.1.1.2	Name of the Marketing Authorisation holder	State Institu for Drug Control
D.2.1.2	Country which granted the Marketing Authorisation	Czech Republic
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	Caelyx
D.3.2	Product code	EU/1/96/011/001
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.11 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)	Yes
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

Chemotherapy of ovarian platinum-resistant carcinoma

Chemoterapie platina rezistentního karcinomu vaječníku

E.1.1.1

Medical condition in easily understood language

Chemotherapy of ovarial carcinoma

Chemoterapie karcinomu vaječníku

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

Our primary aim is to demonstrate that the safety and efficiency of extracorporeal elimination (plasmafiltration) of pegylated liposomal doxorubicin (PLD) is dependent on its kinetically guided regulation i.e. extracorporeal removal should be individualized according to the patient´s elimination capacity.

Naším hlavním cílem je dokázat, že bezpečnost a účinnost plasmafiltrace je závislá na její kinetické regulaci, tj. extrakorporální odstranění léku pegylovaného liposomálního doxorubicinu (PLD) by mělo být individualizováno podle eliminační kapacity pacientky.

E.2.2

Secondary objectives of the trial

Our secondary aim is the detailed monitoring of therapeutic response and PLD toxicities.

Naším druhotným cílem je podrobné monitorování terapeutické odpovědi a PLD toxicity.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Aged between 18 and 60 years. (In consideration of the economic demands, it is not possible to collect a larger group of patients. Nevertheless, in spite of this, it will be possible to achieve significant results of PF effectivity.) Histologically confirmed epithelial ovarian cancer, that of fallopian tube or peritoneal carcinomas. Disease progression (based on clinical signs and symptoms using imaging methods — CT, PET-CT, MR). Tumor marker CA125 elevation. Signed informed consent. Performance state ≤ 1.6. Life expectancy ≤ 12 weeks.

Věk mezi 18 a 60 let. (S ohledem na ekonomické požadavky, není možné shromáždit větší skupině pacientů. Nicméně, navzdory tomu, že bude možné dosáhnout významných výsledků PF účinnosti.) Histologicky potvrzené epitelového karcinomu vaječníků, že z vejcovodu nebo peritoneální karcinomy. progrese onemocnění (na základě klinických příznaků a symptomů s využitím zobrazovacích metod - CT, PET-CT, MR). Nádorový marker CA125 nadmořská výška. Podepsán informovaný souhlas. Stát výkon ≤ 1,6. Průměrná délka života ≤ 12 týdnů.

E.4

Principal exclusion criteria

Severe heart disease, serious hepatic and/or renal dysfunction. Significant myelosuppression induced by previous treatment with cytotoxic agents. Pregnancy and/or lactation. Serious infections.

Závažné onemocnění srdce, vážné jaterní a / nebo renální dysfunkce. Významný myelosuprese vyvolaná předchozí léčbou cytotoxickými látkami. Těhotenství a / nebo kojení. Závažné infekce.

E.5 End points

E.5.1

Primary end point(s)

Progression of disease

Progrese onemocnění

E.5.1.1

Timepoint(s) of evaluation of this end point

1 month

1 měsíc

E.5.2

Secondary end point(s)

Febrile neutropenia according to WHO clasification IV.
Throbocytopenia (III.-IV) associated with bleeding
Anemia (III.-IV.) associated with anemic syndrome
or pancytopenia (III.-IV.)
Hand-foot syndrome according to WHO clasification III.-IV.

Febrilní neutropenie dle klasifikace WHO IV.
Trombocytopenie (III.-IV.) spojená s krvácením
Anemie (III.-IV.) spojená s anemickým syndromem
nebo pancytopenie (III.-IV.)
Hand-foot syndrom dle klasifikace WHO III-IV.

E.5.2.1

Timepoint(s) of evaluation of this end point

more than 10 days

víc než 10 dní

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

Yes

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

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)

Yes

E.8.2.2

Placebo

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

Yes

E.8.4

The trial involves multiple sites in the 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

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

analysis 10 patients treated with CAELYX

analýza 10 pacientek léčených CAELYX

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:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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

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)

At a dose of 50 mg/m2 given as a 1 h IV infusion (Caelyx) every month, patients will be permitted to continue therapy until disease progression or unacceptable toxicity, but a maximum of 6 cycles will be recommended.

Při dávce 50 mg / m2 podáván jako infuze 1 h (Caelyx) každý měsíc, budou pacienti být povoleno pokračovat v léčbě až do progrese onemocnění nebo nepřijatelné toxicity, ale bude doporučeno maximálně 6 cyklů.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Charles University in Prague, Medical Faculty
G.4.3.4	Network Country	Czech Republic

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-04-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-06-09

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

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