Clinical Trial Page

Summary
EudraCT Number:2006-002275-40
Sponsor's Protocol Code Number:2006-002275-40
National Competent Authority:Denmark - DHMA
Clinical Trial Type:EEA CTA
Trial Status:Prematurely Ended
Date on which this record was first entered in the EudraCT database:2008-09-02
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
A. Protocol Information
A.1Member State ConcernedDenmark - DHMA
A.2EudraCT number2006-002275-40
A.3Full title of the trial
Prospective study of patients treated with pegylated interferon-alpha 2b (PegIntron) for metastasizing ileal/coecal carcinoids
A.3.2Name or abbreviated title of the trial where available
NA
A.4.1Sponsor's protocol code number2006-002275-40
A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
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 SponsorUppsala University Hospital, Dept. of Medical Sciences
B.1.3.4CountrySweden
B.3.1 and B.3.2Status of the sponsorNon-Commercial
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 Role
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 Yes
D.2.1.1.1Trade name PegIntron
D.2.1.1.2Name of the Marketing Authorisation holderSchering-Plough Europe, 73, rue de Stalle, B-1180 Bruxelles, Belgium
D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
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.3.4Pharmaceutical form Powder and solvent for solution for injection
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPSubcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNPeginterferon alfa-2b
D.3.9.2Current sponsor codeSCH54031
D.3.9.3Other descriptive namePEG-intron
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNPeginterferon alfa-2b
D.3.9.2Current sponsor codeSCH54031
D.3.9.3Other descriptive namePEG-intron
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number80
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNPeginterferon alfa-2b
D.3.9.2Current sponsor codeSCH54031
D.3.9.3Other descriptive namePEG-intron
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNPeginterferon alfa-2b
D.3.9.2Current sponsor codeSCH54031
D.3.9.3Other descriptive namePEG-intron
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number120
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNPeginterferon alfa-2b
D.3.9.2Current sponsor codeSCH54031
D.3.9.3Other descriptive namePEG-intron
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number150
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
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 No
D.3.11.8Extractive medicinal product No
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
Metastasizing ileal/coecal carcinoids (WHO ICD-10 code: C17.9)
MedDRA Classification
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
To assess the efectivness of two PegIntron doses (0.8ug/kg and 1.6 ug/kg) in inducing a tumour response during 6 months treatment, defined as a reduction of 50% in 5-HIAA, and/or in serum chromagranin A, and /or in tumour size, in patients with metastasizing ileal/coecal carcinoids
E.2.2Secondary objectives of the trial
a) To assess the effectiveness of the PegIntron doses actually used i.e. incorporating possible dose reduction (0.4, 0.8, 1.2 and 1.6 ug/kg), in inducing a tumour response during 6 months treatment, defined as a reduction of 50% in 5-HIAA, and/or in serum chromogranin A, and/or in tumour size, in patients with metastasizing ileal/coecal carcinoids

b) To compare the tolerability between two PegInron doses (0.8 ug/kg and 1.6 ug/kg) at 6 months follow up.

c) To compare the difference in patient quality of life in two PegIntron dose groups (0.8 ug/kg and 1.6 ug/kg) by EORTC QLQ-C30 version 3.0 after 6 months treatment.

d) To investigate the safety of two PegIntron doses (0.8 ug/kg and 1.6 ug/kg) during 6 months treatment.

e) To evaluate the effectiveness of two PegIntron doses (0.8 ug/kg and 1.6 ug/kg) with respect to relief of symptoms related to the carcinoid syndrome.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
Patients suffering from metstasizing, histopathologically verified (chromogranin A and serotonin immunohistochemistry must be positive), highly differentiated NE carcinomas of the jejunum/ileum/valvula Bauhini and the adjacent parts of coecum/colon ascendens. Patients with NE carcinomas of the duodenum, the appendix (including also goblet-cell carcinoids) are not included, neither those with poorly differentiated NE carcinomas (proliferation index higher than 15 %)

Measurable disease as diagnosed by means of CT or MRI according to the RECIST criteria

U-5-HIAA > 2 x upper normal limit and/or P-Chromogranin A > 2 x upper normal limit

Age >18 years.

Life expectancy of more than 12 months

Patients must be willing to give written informed consent
E.4Principal exclusion criteria
Previous or present interferon treatment

Previous radioactive tumour-targeting treatment

Other active or previous neoplasms within 5 years (except non-melanoma skin cancer or in situ cervical cancer)

Liver embolization or radiofrequency ablation within 3 months prior to screening

Patients who have severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease

Contraindications to the investigational product, e.g. known or suspected hypersensitivity
E.5 End points
E.5.1Primary end point(s)
The primary endpoint is the tumour responses after 6 months treatment or at withdrawal. The patients are grouped to the doses, which they are randomized to.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans Information not present in EudraCT
E.7.1.2Bioequivalence study Information not present in EudraCT
E.7.1.3Other Information not present in EudraCT
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group Yes
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 Yes
E.8.2.3.1Comparator description
two different doses
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 Yes
E.8.4.1Number of sites anticipated in Member State concerned3
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA9
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
E.8.7Trial has a data monitoring committee No
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 months
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years2
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) Yes
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
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 state30
F.4.2 For a multinational trial
F.4.2.1In the EEA 90
F.4.2.2In the whole clinical trial 90
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 Decision2008-09-23
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2008-09-17
P. End of Trial
P.End of Trial StatusPrematurely Ended

Sponsors and Collaborators

Medical Conditions

Drug Interventions

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