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    Summary
    EudraCT Number:2005-005569-12
    Sponsor's Protocol Code Number:CSTI571E2203
    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:2005-12-02
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2005-005569-12
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension.
    A.4.1Sponsor's protocol code numberCSTI571E2203
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 Yes
    D.2.1.1.1Trade name Glivec
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/01/021
    D.3 Description of the IMP
    D.3.1Product nameGlivec
    D.3.2Product code STI571
    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 INNImatinib
    D.3.9.2Current sponsor codeSTI571
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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.IMP: 2
    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 No
    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.3.2Product code STI571
    D.3.4Pharmaceutical form Coated tablet
    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 INNImatinib
    D.3.9.2Current sponsor codeSTI571
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    pulmonary arterial hypertension
    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 safety and tolerability of oral STI571 compared with placebo in patients with pulmonary arterial hypertension.
    • To evaluate efficacy of oral STI571 as measured by improvement in 6-minute walk test.
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of oral STI571 as measured by improvement Borg dyspoena scale, clinical status (WHO/NYHA class and dyspoena score), and changes in pulmonary haemodynamic parameters (including mean pulmonary arterial pressure, cardiac output and pulmonary vascular resistance) time to clinical worsening, changes in plasma biomarker levels.
    •To collect and monitor safety data of imatinib, provided as open-label medication to patients with pulmonary arterial hypertension (PAH) who were enrolled in the six month randomised, placebo controlled STI571E2203.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients equal to or greater than 18 years of age.
    2. Diagnosis of pulmonary arterial hypertension (PAH) according to the Venice classification system (2003), of either primary (idiopathic), familial or secondary to systemic sclerosis (excluding those with marked pulmonary fibrosis).
    3. Patients must have symptoms with a WHO class of II-IV (maximum of 50% of patients WHO Class IV will be included in the study).
    4.Patients must have pulmonary vascular resistance (PVR) > 300 dyn sec-1 cm-5.
    5. PAH medication must have been stable for at least 3 months prior to inclusion in the study (Baseline visit).
    6. Female patients of child bearing potential must be using a double-barrier local contraception, i.e. intra-uterine device plus condom, or spermicidal gel plus condom or oral contraceptive plus condom up to completion of the Study Completion visit.
    7. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
    OPEN LABEL PHASE:
    1. Males and Females equal to or greater than 18 years of age
    2. Diagnosis of pulmonary arterial hypertension (PAH) according to the Venice classification system (2003), of either primary (idiopathic), familial or secondary to systemic sclerosis (excluding those with marked pulmonary fibrosis).
    3. Female patients of child bearing potential must be using a double-barrier contraception, i.e. intra-uterine device plus condom, or spermicidal gel plus condom or oral contraceptive plus condom up to completion of the Study Completion visit.
    4. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
    5. Subjects who are presently receiving imatinib following participation in teh randomised STI571E2203 study or subjects who will complete participation in the six month randomised STI571E2203 study.
    E.4Principal exclusion criteria
    1. Use of unspecific phosphodiesterase inhibitors e.g. pentoxyfillin, enoximon, milrinone or pimobendan for the duration of the trial (screening visit to last measurement performed/ Study close-out visit).
    2.Chronic inhaled Nitric oxide therapy from baseline to study completion visit (screening visit to last measurement performed/ Study completion visit).
    3. Treatment with catecholamines (e.g. adrenalin > 500 ng/kg x min, noradrenalin > 500ng/kg x min, dopamine >5 ng/kg x min.), from screening visit to last measurement performed/ Study close-out visit.
    4. Grapefruit juice should not be drunk whilst patients participate in the study.
    5. Patient who have taken over-the-counter (OTC) medication (vitamins, herbal supplements and dietary supplements) within four (4) weeks prior to dosing. Paracetamol is acceptable, but must be documented in the Concomitant medications / Significant non-drug therapies page of the CRF.
    6.Participation in any treatment studies within 3 months prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations. Although patients on open long term extensions from other trials can participate in this study providing that the formal study period is over.
    7. Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
    8. History of other significant illness within four weeks prior to dosing.
    9. Pre-exisiting lung disease including parasitic diseases affecting lungs, congenital abnormalities of the lungs, thorax or diaphragm or bronchial asthma
    associated with chronic hypoxia that may contribute to the severity of Pulmonary Arterial Hypertension
    10. Pulmonary artery or valve stenosis (documented by corresponding pressure gradients detected at right heart catheterization),
    11. Pulmonary venous hypertension with pulmonary capillary wedge pressure (PCWP) in excess of 12 mmHg
    12. Chronic thromboembolic pulmonary hypertension
    13. Acute heart failure or chronic left sided heart failure
    14. Severe (systemic) arterial hypertension (> 200 mmHg (systolic) or > 120 mmHg (diastolic))
    15. Congenital or acquired valvular or myocardial disease
    16. Deficiencies of blood coagulation (i.e. based on relevant changes in coagulation parameters), inherited or acquired blood coagulation disorders e.g. defects in factor VIII (Haemophilia A, v. Willebrand syndrome), factor XII, factor XIII; decreased generation of coagulation factors due to acute or chronic liver diseases, deficient coagulation due to auto-antibodies against coagulation factors such as in lupus anticoagulant
    17. Disseminated intravascular coagulation (DIC)
    18. Deficient thrombocyte function, thrombocytopenia < 40000/µl
    19. Evidence of major bleeding or intracranial hemorrhage
    20. History of latent bleeding risk such as diabetic retinopathy, gastrointestinal bleeding (due to gastric or duodenal ulcers) or colitis ulcerosa.
    21. Moderate hepatic insufficiency Transaminase levels >4 fold the upper limit of normal or a bilirubin > 2 fold the upper limit of normal. Elevated transaminase level should be carefully monitored because of known liver toxicity of STI571.
    22. Renal insufficiency (serum creatinine > 200 µmol/l)
    23. Previous therapeutic radiation of lungs or mediastinum
    24. History of elevated intracranial pressure (ICP  20 mmHg).
    25. Pregnancy, breast feeding
    26. Patients whose underlying disease is not likely to permit them to survive the study
    27. Sickle cell anemia
    28. History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
    29. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the patient in case of participation in the study. The investigator should be guided by evidence of any of the following:
    •history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding;
    •history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
    30. History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
    31. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
    32. History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
    33. Those unable to perform the six minute walk test due to disability from another condition eg arthritis
    OPEN LABEL PHASE
    see amdt 10 due to space restrictions.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy analysis, will be on the difference between six minute walk tests at Week 24 between the two treatment groups, appropriate statistical testing will be performed on an intention to treat basis. A secondary analysis on the per protocol population will also be performed.
    Further analysis will be performed on all other secondary variables, where the mean and confidence interval for each variable will be listed and appropriate statistical comparisons made.
    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 No
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    open label phase after 6 months.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Open label phase after 6 months
    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.8.5The trial involves multiple Member States Yes
    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 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
    Last visit of last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    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 60
    F.4.2.2In the whole clinical trial 60
    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
    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 Decision2005-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-31
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