Clinical Trials Register

Summary
EudraCT Number:	2007-007727-41
Sponsor's Protocol Code Number:	DTS-201CLI002
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2008-09-30
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2007-007727-41

A.3

Full title of the trial

An open-label, one arm, multi-centre Phase II trial evaluating the efficacy and safety of DTS-201 as a second-line chemotherapy in patients with hormone refractory prostate cancer

A.3.2

Name or abbreviated title of the trial where available

DTS-201CLI002

A.4.1

Sponsor's protocol code number

DTS-201CLI002

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

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	DIATOS.SA.
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
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	No
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	DTS-201
D.3.2	Product code	DTS-201
D.3.4	Pharmaceutical form	Powder for infusion*
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	DTS-201
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)	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	L’IMP e' un profarmaco, la sostanza attiva e' un peptide unito alla doxorubicina

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

Hormone Refractory Prostate Cancer

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10062904
E.1.2	Term	Hormone-refractory prostate cancer

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 determine the rate of PSA response (≥ 50% decline of PSA value)

E.2.2

Secondary objectives of the trial

-To assess safety -To determine time to PSA progression -To determine duration of PSA response -To determine tumour response as per RECIST criteria -To determine overall survival -To assess pharmacokinetics of DTS-201 -To assess CD10 & TOP expression

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Male patients ≥ 18 years. 2.Performance status Karnofsy ≥ 70%. 3.Life expectancy > 3 months. 4.Histologically documented adenocarcinoma of the prostate. 5.Patient with one prior line of chemotherapy only. 6.Patients should have documented progression of disease. Disease progression should meet at least one of the following criteria: a.PSA evidence of progressive prostate cancer during or within 60 days of cessation of first-line chemotherapy consists of a PSA level ≥ 5 ng/ml that has risen on ≥ successive occasions ≥ 2 weeks apart. b.Progression of measurable disease as defined by RECIST criteria (confer Appendix 3). c.Progression of bone disease characterized by appearance of one or more new bone lesions. 7.Adequate castration (testosterone levels ≤ 50 ng/dL), by orchiectomy or by LHRH agonist. 8.Patients receiving bisphosphate therapy must be on stable doses with stable symptoms prior to enrolment. 9.Adequate hematological and biological functions: Bone marrow function: Neutrophils ≥ 1500/mm3, hemoglobin ≥ 10g/dl, platelets ≥ 100 000/mm3. Hepatic function: Bilirubin < 1.5 ULN Alkaline phosphatase (AP) ≤ 1.5 ULN, (or AP ≤ 5 ULN for patients with bone metastasis). AST/ALT ≤ 1.5 ULN (or AST/ALT ≤ 3 ULN for patients with liver metastasis). Renal function: normal with creatinine clearance ≥ 60 ml/min. 10.Normal cardiac function at clinical examination and LVEF ≥ 50% (according to MUGA scan or cardiac echography). No history of myocardial infarction within last 12 months. 11.Signed informed consent obtained prior to initiation of any study-specific procedures and treatment. 12.Able to adhere to the study visit schedule and other protocol requirements. 13.Essere affiliato o benificiare a un sistema di previdenza sociale se applicabile

E.4

Principal exclusion criteria

1.Previous treatment with an anthracycline or mithoxantrone. 2.Radiotherapy or radioisotope therapy within 4 weeks prior to study drug treatment. 3.Anticancer therapy (chemotherapy, hormone therapy, immunotherapy or biological therapy response modifiers) within 4 weeks prior to study drug first dosing. 4.Steroid therapy within 4 weeks prior to study drug first dosing. 5.Multivitamins, Vitamin D, Calcitrol, and other alternative and food supplement must be discontinued before study registration. 6.Symptomatic brain metastasis per leptomeningeal metastasis or evidence of cord spinal compression. 7.Prior radiotherapy to more than 30% of the bone marrow. 8.Uncontrolled hypercalcemia. 9.History of other malignancies within 5 years at screening, except for adequately treated basal or squamous cell skin cancer 10.Presence of any serious concomitant systemic disorders incompatible with the study (e.g. active infection). 11.Known positive status for HIV and/or active Hepatitis B or C. 12.Less than 4 weeks after participation to another trial 13.Any other reason suspected by investigator as incompatible with study participation.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint of trial is the overall tumour response based on total serum PSA value.

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

Yes

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

E.8.1.2

Open

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)

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

Information not present in EudraCT

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

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.1.3

Elderly (>=65 years)

Yes

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

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)

Trattamento standard di questa fase di malattia

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

2008-11-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-06-11

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

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