Kliniska prövningar Nct sida

Summary
EudraCT Number:2004-004533-34
Sponsor's Protocol Code Number:BIOV-221
National Competent Authority:UK - MHRA
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2005-09-22
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
A. Protocol Information
A.1Member State ConcernedUK - MHRA
A.2EudraCT number2004-004533-34
A.3Full title of the trial
A Phase IV Non-randomised Study of Modrenal® (Trilostane) in
Post-menopausal Women with Advanced, Oestrogen Receptor Positive Breast Cancer for whom Prior Endocrine Therapies have Failed, One of which was an Aromatase Inhibitor
A.4.1Sponsor's protocol code numberBIOV-221
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorBioenvision
B.1.3.4CountryUnited Kingdom
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name Modrenal 120mg Capsules
D.2.1.1.2Name of the Marketing Authorisation holderBioenvision Ltd.
D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameModrenal Capsules
D.3.2Product code Trilostane
D.3.4Pharmaceutical form Capsule, hard
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNTrilostane
D.3.9.1CAS number 13647-35-3
D.3.9.2Current sponsor codeTrilostane
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number120
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another 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.1.1Medical condition(s) being investigated
Advanced, Oestrogen Receptor Positive Breast Cancer for whom Prior Endocrine Therapies have Failed, One of which was an Aromatase Inhibitor
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 7.0
E.1.2Level LLT
E.1.2Classification code 10057654
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Primary Objective:
The primary objective is to determine with a specified level of precision the clinical benefit rate (CBR) of up to 6 months treatment with trilostane 720 mg and concomitant hydrocortisone 20 mg in post menopausal women with advanced, ER positive breast cancer for whom prior endocrine therapies have failed, one of which was an AI.
E.2.2Secondary objectives of the trial
Secondary Objectives:
•To determine objective tumour response
•To determine toxicity
•To determine time to PD
•To determine duration of response
•To determine performance status
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
•Patients must provide written informed consent prior to any study procedures being performed and according to local ethics committee guidelines
•Female patients aged over 18 years
•Patients must be post-menopausal, defined as >12 months since last menses. In patients whose last menses was ≤12 months before start of treatment, follicle stimulating hormone (FSH) and luteinising hormone (LH) levels must be in post-menopausal range: FSH ≥35 IU/L and LH >40 IU/L
•Patients must have histological diagnosis of ER positive breast cancer and have relapsed or are refractory to hormone therapies, one of which must have been a new generation AI (letrozole, exemestane or anastrozole), prior to Screening
•Patients must have performance status ≤2 ECOG scale
•Patients must be suitable for hormone therapy in the investigator’s opinion
•Patients with a life expectancy of >3 months
•Patients with bone metastases are eligible provided that they have evaluable sites of metastases that can be followed by x-ray, MRI/CT scan
•Patients must have measurable disease according to the RECIST criteria
•All prior hormonal therapy must have failed (ie, either relapsed or refractory)
•Patients must have haemoglobin ≥9.0 g/dL (after transfusion if needed) at Screening
•Patients must have a white blood cell (WBC) count ≥3,500/mm3 at Screening
•Patients must have neutrophils ≥1,500/mm3 at Screening
•Patients must have platelets ≥100,000/mm3 at Screening
•Patients must have creatinine ≤1.5 x upper limit of normal (ULN) for the testing laboratory, or a creatinine clearance ≥60 mL/minute at Screening
•Patients must have serum bilirubin ≤1.5 mg/dL at Screening
•Patients must have aspartate transaminase (AST), alanine transaminase (ALT) and alkaline phosphatase (ALP) ≤2 x ULN, or if liver metastases by ultrasound or magnetic resonance imaging (MRI) scan ≤5 x ULN at Screening
E.4Principal exclusion criteria
1)Patients with inflammatory breast cancer
2)Patients with concurrent medical or psychiatric problems, unrelated to breast cancer, which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
3)Patients who are hypocortisolaemic
4)Patients who have received treatment with another investigational therapy including hormonal therapy within 30 days or five half-lives (whichever is longer) prior to entry into the study
5)Patients who are presently receiving or expect to require concurrent chemotherapy, immunotherapy, radiotherapy or chronic corticosteroid therapy. Patients who have received prior adjuvant chemotherapy will be eligible, provided the chemotherapy was administered prior to hormonal therapy and its use was stopped at least 6 months prior to study enrolment
6)Any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
7)Patients with brain metastases
8)Patients with severe concurrent illness
9)Patients who previously participated in the study
10)Patients with known adrenal insufficiency
E.5 End points
E.5.1Primary end point(s)
CBR is defined as the proportion of patients with any of the following assessments using the Response Evaluation Criteria in Solid Tumours (RECIST) system (see Appendix II) at both the 3-month and 6 month visits:
•CR
•PR
•SD

CR and PR must be subsequently confirmed 4 weeks later.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis Information not present in EudraCT
E.6.2Prophylaxis Information not present in EudraCT
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Information not present in EudraCT
E.6.6Pharmacokinetic Information not present in EudraCT
E.6.7Pharmacodynamic Information not present in EudraCT
E.6.8Bioequivalence Information not present in EudraCT
E.6.9Dose response Information not present in EudraCT
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic Information not present in EudraCT
E.6.12Pharmacoeconomic Information not present in EudraCT
E.6.13Others Information not present in EudraCT
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) Yes
E.8 Design of the trial
E.8.1Controlled No
E.8.1.1Randomised No
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other No
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned No
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial has a data monitoring committee Information not present in EudraCT
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.8.9.1In the Member State concerned years2
E.8.9.1In the Member State concerned months0
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years2
E.8.9.2In all countries concerned by the trial months0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male No
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state61
F.4.2 For a multinational trial
F.4.2.1In the EEA 61
F.4.2.2In the whole clinical trial 61
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2005-01-18
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2005-05-19
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2008-02-08

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