Clinical Trials Register

Summary
EudraCT Number:	2011-000272-34
Sponsor's Protocol Code Number:	L00070-IN-214-P1
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:	2011-06-20
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

2011-000272-34

A.3

Full title of the trial

Phase II study assessing the maintenance treatment with vinflunine after first-line therapy with gemcitabine and cisplatin in patients with advanced or metastatic transitional cell carcinoma of the urothelial tract.

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

JASiMA - JAVLOR Switch in Maintenance

A.4.1

Sponsor's protocol code number

L00070-IN-214-P1

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	PIERRE FABRE MEDICAMENT
B.1.3.4	Country	France
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	PIERRE FABRE MEDICAMENT
B.4.2	Country	France
B.4.1	Name of organisation providing support	PIERRE FABRE PHARMA 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	Pierre Fabre Medicament
B.5.2	Functional name of contact point	RIGGI
B.5.3	Address:
B.5.3.1	Street Address	45 place Abel Gance
B.5.3.2	Town/ city	Boulogne
B.5.3.3	Post code	92100
B.5.3.4	Country	France
B.5.4	Telephone number	33 (0) 1.49.10.81.77
B.5.5	Fax number	33 (0) 1.49.10.83.28
B.5.6	E-mail	marcello.riggi@pierre-fabre.com

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	JAVLOR
D.2.1.1.2	Name of the Marketing Authorisation holder	PIERRE FABRE MEDICAMENT
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.3.1	Product name	JAVLOR
D.3.2	Product code	L00070
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VINFLUNINE
D.3.9.1	CAS number	162652-95-1
D.3.9.2	Current sponsor code	L00070
D.3.9.4	EV Substance Code	SUB00063MIG
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	25
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

Advanced or metastatic predominantly transitional cell carcinoma of the urothelial tract.

E.1.1.1

Medical condition in easily understood language

Bladder Cancer

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	16.1
E.1.2	Level	LLT
E.1.2	Classification code	10046722
E.1.2	Term	Urothelial carcinoma bladder stage IV
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

Progression-free survival rate (PFS-R) at 3 months after registration

E.2.2

Secondary objectives of the trial

- Overall response rate(ORR); duration of response; duration of stable disease
- Response upgrade rate;disease control rate (DCR); duration of disease control
- Progression free survival time (PFS); Time to treatment failure (TTF)
- Overall survival time (OS)
- Quality of life (EORTC QLQ-C30 questionnaire)
- Safety and tolerability

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Patients aged ≥ 18 years
2) Histologically confirmed diagnosis of locally advanced or metastatic predominantly transitional cell carcinoma of the urothelium (TCCU) [urinary bladder, kidney, renal pelvis, or ureter]. Not amenable to definitive local/regional therapy.
3) Stable Disease, Partial Response or Complete Response as outcome of 1st line treatment with the gemcitabine-cisplatin combination for advanced/metastatic TCCU (confirmed or not).
4) Completion of 4 cycles of 1st line treatment with the gemcitabine-cisplatin combination for the chemo-naïve advanced/metastatic TCCU patient and no persistence of any adverse event > Grade 1 related to this treatment.
5) Last administration of gemcitabine and cisplatin (i.e. last day of administration of both compounds) ≤ 6 weeks before registration.
6) The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means any assessment or evaluation that would not be part of the routine medical care of the patient.
7) Women of childbearing potential must be using a medically accepted method of contraception (i.e. hormonal contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment.
8) Fertile men must be using an effective method of birth control, if their partners are women of childbearing potential, during the study period and up to 3 months after last administration of study medication.
9) ECOG performance status of 0 or 1 (patients aged ≥ 80 years with ECOG performance status 1 or ECOG performance status 0 and prior irradiation of the pelvic area are not eligible)
10) Estimated life expectancy of at least 3 months
11) Adequate haematological, renal and hepatic functions as evidenced by:
- Absolute Neutrophil Count ≥ 1,500/mm³ (≥1.5 x 10^9/L)
- Haemoglobin ≥ 9 g/dL
- Platelet count ≥ 100,000/mm³
- Serum total bilirubin ≤1.5 x upper limit of normal (ULN)
- Transaminases ≤ 2.5 x ULN [ ≤ 5 times ULN only in case of liver
metastasis]
- Alkaline phosphatase ≤ 5 x ULN
- Calculated creatinine clearance (CrCL) (Cockroft-Gault):
• ≥ 20 mL/min for age < 75 years
• ≥ 40 mL/min for age ≥ 75 to < 80 years
• > 60 mL/min for age ≥ 80 years

E.4

Principal exclusion criteria

1) Patients aged < 18 years.
2) Patients with predominantly non-TCCU (adenocarcinoma, squamous cell carcinoma or other).
3) Prior administration of any systemic anti-tumour therapy (other than Gemcitabine-cisplatin-combination) for treatment of TCCU.
4) Progressive Disease during or after 1st line treatment with the gemcitabine cisplatin combination for advanced/metastatic TCCU.
5) Known brain metastasis or leptomeningeal involvement (CT Scan/MRI not required to rule this out unless there is clinical suspicion of CNS disease).
6) Peripheral neuropathy ≥ Grade 2.
7) Any serious, concurrent illness or uncontrolled medical disorder including active infection requiring antibiotics within 2 weeks before registration, uncontrolled cardiac arrhythmia, unstable diabetes mellitus, uncontrolled hypercalcaemia, congestive heart failure, poorly controlled hypertension, unstable angina pectoris, or myocardial infarction within 6 months before registration.
8) Screening-electrocardiogram with any significant modifications suggesting a high risk of occurrence of an acute clinical event (such as angina pectoris, high risk arrhythmia, etc.).
9) Prior other malignancy. Note: Patients who have had another malignancy and who have been disease-free for at least 3 years or patients with a history of successfully treated basal cell carcinoma of the skin or in-situ cervix carcinoma or localised prostate cancer with limited risk of recurrence (pT ≤ 2b, Gleason score ≤ 7) that was incidentally discovered and did not lead to any other treatment apart from prostatectomy are eligible.
10) Known hypersensitivity to vinca alkaloids.
11) Prior radiation to ≥ 30% of the bone marrow or radiation not completed at least 28 days before registration or current persistence of any adverse event >Grade 1 related to this treatment.
12) Major surgery or trauma within 28 days before registration or presence of any major non-healing wound, fracture or ulcer.
13) Prior participation in an interventional clinical study investigating drugs within 30 days before registration, during the treatment period.
14) Current treatment with any potent CYP3A4-inhibitor or -inducer
15) Pregnant or lactating women or women with positive pregnancy test at screening.
16) Any serious and/or unstable pre-existing medical, psychiatric, psychological, familial, sociological, geographical or other condition that could interfere with the patient’s safety, provision of informed consent, or compliance with the study protocol.
17) Prisoners or persons who are compulsory detained (involuntary incarcerated).

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is to determine the Progression-free survival rate (PFS-R) at 3 months after registration

E.5.1.1

Timepoint(s) of evaluation of this end point

3 months after registration

E.5.2

Secondary end point(s)

· Overall response rate(ORR); duration of response; duration of stable disease
· Response upgrade rate;disease control rate (DCR); duration of disease
control
· Progression free survival time (PFS); Time to treatment failure (TTF)
· Overall survival time (OS)
· Quality of life (EORTC QLQ-C30 questionnaire)
· Safety and tolerability

E.5.2.1

Timepoint(s) of evaluation of this end point

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

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)

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

E.8.1.1

Randomised

Information not present in EudraCT

E.8.1.2

Open

Information not present in EudraCT

E.8.1.3

Single blind

Information not present in EudraCT

E.8.1.4

Double blind

Information not present in EudraCT

E.8.1.5

Parallel group

Information not present in EudraCT

E.8.1.6

Cross over

Information not present in EudraCT

E.8.1.7

Other

Information not present in EudraCT

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

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

The end of study is defined as at least 3 months after the last administration of Vinflunine in the last patient under study treatment. Survival information will be collected every 3 months until death or decision for study closure.

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

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

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)

Yes

F.1.3.1

Number of subjects for this age range:

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

Yes

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

Pts should be followed until death/study closure. It is planned that inv. discusses further options with pt after end of study treatment according to the available oncological treatment options, that he performs the selected subsequent treatment and that the documents it in the CRF. If possible subsequent treatment should be performed in the center in order to allow for continuity. However, subsequent treatment might also be performed by the general practitioner/oncologists/urologists.

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

2011-07-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-08-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-02-14

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