Clinical Trials Register

Summary
EudraCT Number:	2011-005116-28
Sponsor's Protocol Code Number:	38495
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-08-01
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

Netherlands - Competent Authority

A.2

EudraCT number

2011-005116-28

A.3

Full title of the trial

A phase I/II trial of Cabazitaxel +/- Rhenium-188 HEDP in patients with metastatic castration resistant prostate cancer who progressed on or after a docetaxel containing treatment.
The ReCab trial

Een studie van combinatie van Rhenium-188-HEDP en Cabazitaxel in patiënten met naar het bot uitgezaaide prostaatkanker die onvoldoende reageren op hormonale controle en Docetaxel: de ReCab 1 studie

A.3.1

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

A phase I/II trial of Cabazitaxel +/- Rhenium-188 HEDP in patients with metastatic castration resistant prostate cancer who progressed on or after a docetaxel containing treatment.
The ReCab trial

Een studie van combinatie van Rhenium-188-HEDP en Cabazitaxel in patiënten met naar het bot uitgezaaide prostaatkanker die onvoldoende reageren op hormonale controle en Docetaxel: de ReCab 1 studie

A.3.2

Name or abbreviated title of the trial where available

ReCab trial

ReCab sudie

A.4.1

Sponsor's protocol code number

38495

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information

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	Cabazitaxel
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi-Aventis
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Cabazitaxel
D.3.2	Product code	XRP6258
D.3.4	Pharmaceutical form	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	Jevtana
D.3.9.1	CAS number	183133-96-2
D.3.9.2	Current sponsor code	XRP6258
D.3.9.3	Other descriptive name	CABAZITAXEL
D.3.9.4	EV Substance Code	SUB31282
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	up to
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

Metastatic prostate cancer/bone metastases

Uitgezaaide prostaatkanker met botuitzaaiingen

E.1.1.1

Medical condition in easily understood language

metastatic prostate cancer

uitgezaaide prostaatkanker

E.1.1.2

Therapeutic area

Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

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

Primary objectives:
To establish a safe and effective dosing schedule for repeated administration of Rhenium-188 HEDP combined with cabazitaxel in order to proceed with a Randomized Phase 2 trial designed to determine the clinical value of Rhenium-188 HEDP/cabazitaxel using overall survival as the primary endpoint. Patients included in the phase1 part with the dose schedule selected for the phase 2 part will be integrated in the final phase 2 analysis.

Onderzoeken van veiligheid en effeciviteit van de combinatie van rhenium-188-HEDP en cabazitaxel in een dosis escalatie studie, gevolgd door een gerandomiseerde fase 2 studie

E.2.2

Secondary objectives of the trial

Secondary objectives:
Evaluate time to progression, clinical benefit response and toxicity

tijd tot ziekte progressie, klinisch effect, response en toxiciteit

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• mCRPC patients with documented disease progression;
- If measureable: (RECIST) progression
- If non-measurable: documented rising PSA levels (at least 2 consecutive rises in PSA over a reference value taken at least 1 week apart) or appearance of new lesion
• Previous treatment with a docetaxel-containing regimen
• WHO performance status 0 or 1.
• Life expectancy of at least 3 months.
• Age > 18years.
• Adequate renal function defined as serum creatinin ≤ 1.5 x ULN and/or calculated creatinin clearance 50ml/min
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x
109/L
• Total bilirubin ≤ 1 x ULN, ALT, AST ≤ 2.5 x ULN
• Alkaline phosphatase < 10 x ULN.
• Absence of any psychological, familial, sociological or geographical
condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
• Written informed consent
• Bone metastases must show uptake of Tc-99m-HDP on bone
scintigraphy
• Adequate hematological function defined as: Haemoglobin > 9 g/dl;
Total White cell count >4.0 x 109/l; Platelet count >100 x 109/l.
• Patients under LH-RH agonists must continue their treatment.
• Prior hormonal therapy for prostate cancer, resulting in serum testosterone < 50ng/dl

Hormoon en docetaxel resistent prostaatcarcinoom.

E.4

Principal exclusion criteria

• Previous exposure to combined Rhenium -188- HEDP and docetaxel treatment.
• Active uncontrolled bacterial, viral or fungal infection.
• History of another malignancy within the last five years except adequately treated basal cell carcinoma of skin.
• Organ allografts requiring immunosuppressive therapy.
• Serious uncontrolled concomitant disease.

eerdere behandeling met combinaie van rhenium-188-HEDP en docetaxel

E.5 End points

E.5.1

Primary end point(s)

Phase I:
Dose Limiting Toxicity (DLT) is defined as any grade 4 toxicity lasting >7 days, or any grade 3 toxicity which does not recover within 10 days. If a DLT occurs in 1 of the 3 patients in a particular treatment level, the group will be expanded to 6 patients. If 2 or more of the group experience a DLT, we will treat the next 3 patients at the previous dose level (i.e. If DLT in >2/6 at dose level 2, 3 patients will be treated at dose level 1. If none of the group of 3 or <1/6 experience DLT, 3 patients will be treated at the next dose level. The final group of 3 patients will be treated at a planned dose of 6 cycles of cabazitaxel 25mg/m2 and 2 cycles of Rhenium-188 HEDP (40 MBq/kg).
Phase II:
Efficacy Parameters
TTP (time to progression ) will be the primary efficacy endpoint.
Furthermore, PSA, and clinical benefit response (Skeletal Related Events, Qol, Pain and Palliative Medication). .
Safety Parameters:
Adverse events and clinical laboratory parameters including hematology (complete blood counts including differential and platelets), survival. NCI toxicity criteria will be followed.

dosis limiterende toxiciteit (fase 1).

Tijd tot ziekte progressie (fase 2)

E.5.1.1

Timepoint(s) of evaluation of this end point

end of studie

einde van studie

E.5.2

Secondary end point(s)

toxicity and progression of disease

toxiciteit en ziekte progressie

E.5.2.1

Timepoint(s) of evaluation of this end point

during the study

gedurende de studie

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

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

phase I: Combination of two drugs that are both extensively studied in previous trials

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

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

rhenium-188-HEDP met cabzitaxel versus cabazitaxel alleen

rhenium-188-HEDP + cabazitaxel versus cabazitaxel alone

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

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

last visit

Laaste controle

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

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)

Yes

F.1.3.1

Number of subjects for this age range:

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)

standard care

standaard behandeling

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-08-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-09-10

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

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