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Summary
EudraCT Number:2004-001749-13
Sponsor's Protocol Code Number:P04071
National Competent Authority:Austria - BASG
Clinical Trial Type:EEA CTA
Trial Status:Prematurely Ended
Date on which this record was first entered in the EudraCT database:2004-12-17
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 ConcernedAustria - BASG
A.2EudraCT number2004-001749-13
A.3Full title of the trial
Randomized Phase II Study: Temozolomide (TMZ) Concomitant to Radiotherapy followed by sequential TMZ in Advanced NSCLC Patients with CNS Metastasis versus Radiotherapy alone
A.4.1Sponsor's protocol code numberP04071
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 SponsorAESCA Pharma GesmbH
B.1.3.4CountryAustria
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 Temodal
D.2.1.1.2Name of the Marketing Authorisation holderSP Europe
D.2.1.2Country which granted the Marketing AuthorisationAustria
D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameTemodal
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.3.11 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) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.3.2Gene therapy medical product Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.11Herbal medicinal product Information not present in EudraCT
D.3.11.12Homeopathic medicinal product Information not present in EudraCT
D.3.11.13Another type of medicinal product Yes
D.3.11.13.1Other medicinal product typeantineoplastic
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
Patients with non small cell lung cancer (NSCLC) have a high risk of developing brain metastasis, up to 40% as evaluated in autopsy studies. These patients are often heavily symptomatic and their life expectancy remains limited (median 5.4 months), using corticosteroids and radiotherapy or radiosurgery alone.
MedDRA Classification
E.1.3Condition being studied is a rare disease Yes
E.2 Objective of the trial
E.2.1Main objective of the trial
Assess safety and toxicity of concomitant chemotherapy with TMZ at low dose during the whole brain radiation and later on at the 14 days on/14days off schedule in patients with cerebral metastases.
E.2.2Secondary objectives of the trial
As additional parameters progression free survival at 6 month (PFS-6) and the duration of overall survival (OS) will be recorded and compared to patients receiving radiation therapy alone.
Evaluation of Quality of Life analysis (EORTC QLQ-C 30 + Brain Cancer module) and evaluation of neurological functioning during treatment (optional) using the Mini Mental Score and the EFIT test (Edinburgh Functional Impairment Test), consisting of the nine hole peg test, the ten meter walk test, Boston Aphasia rating scale and the Williams Delayed Recall Test.
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
·Prior histologic confirmation of NSCLC
·Optional: NSCLC histologic confirmation of metastasis of NSCLC
·Presence of bidimensionally measurable disease in the brain
·No previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin.
·Age: > 18 years
·No evidence of progression at extracranial sites
·Karnofsky Performance status ³ 60 %
·ANC > 1.500/mm3 , platelets > 100.000/mm3, hemoglobin > 8g/dl
·Serum creatinine and bilirubine < 1.5 times upper normal limit of testing laboratory
·SGOT; SGPT < 3 times upper limit of testing laboratory
·Palliative radiation therapy to thorax and bone or other organs (except brain) is acceptable.
·Prior neurosurgery > 2 weeks from initiating treatment with TMZ
·Cortisone medication stable or decreasing within 2 weeks prior to initiating treatment with TMZ
·Patient is not pregnant or nursing and is advised and willing to use an effective method of contraception
·Written informed consent
E.4Principal exclusion criteria
·Chemotherapy or biologic therapy within four weeks prior initiating therapy with TMZ
·Prior radiation therapy for brain < 4 weeks from initiating therapy with TMZ
·Surgery within two weeks prior to TMZ administration
·Known HIV disease
·Acute infection requiring intravenous antibiotics
·Rapid disease progression outside of brain at study entrance.
·Any reason making compliance to the protocol improbable
E.5 End points
E.5.1Primary end point(s)
The objective of this trial is to assess safety and toxicity of concomitant chemotherapy with Temozolomide (TMZ) at low dose during the whole brain radiation and later on at the two weeks on, two weeks off schedule in patients with cerebral metastases from non small cell lung cancer (NSCLC).
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 Yes
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) 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 Yes
E.8.1.3Single blind Information not present in EudraCT
E.8.1.4Double blind Information not present in EudraCT
E.8.1.5Parallel group Information not present in EudraCT
E.8.1.6Cross over Information not present in EudraCT
E.8.1.7Other Information not present in EudraCT
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Information not present in EudraCT
E.8.2.2Placebo Information not present in EudraCT
E.8.2.3Other Yes
E.8.2.3.1Comparator description
radiotherapy alone
E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.5The trial involves multiple Member States Information not present in EudraCT
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
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
The active phase of the trial ends after the evaluation of activity, safety and QoL following the 6th cycle of sequential Temodal given to the last patient.
Survival data will be collected for 12 additional months
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years3
E.8.9.1In the Member State concerned months
E.8.9.1In the Member State concerned days
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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2004-12-17. Yes
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 state92
F.4.2 For a multinational trial
F.4.2.2In the whole clinical trial 92
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 Decision2005-02-22
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2005-02-22
P. End of Trial
P.End of Trial StatusPrematurely Ended
P.Date of the global end of the trial2008-08-28

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