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Summary
EudraCT Number:2004-001450-84
Sponsor's Protocol Code Number:XM02-03-INT
National Competent Authority:Hungary - National Institute of Pharmacy
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2004-08-05
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 ConcernedHungary - National Institute of Pharmacy
A.2EudraCT number2004-001450-84
A.3Full title of the trial
Safety and Efficacy of XM 02 in patients with small cell or non small cell lung cancer receiving platinum-based chemotherapy. Multinational, multicentre, randomised, controlled study
A.4.1Sponsor's protocol code numberXM02-03-INT
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 SponsorBioGeneriX
B.1.3.4CountryGermany
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.2.5The 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 name(r-metHuG-CSF)
D.3.2Product code XM02
D.3.4Pharmaceutical form 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.3.9.1CAS number 121181-53-1
D.3.9.2Current sponsor codeXM02
D.3.9.3Other descriptive name(r-metHuG-CSF)
D.3.10 Strength
D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
D.3.10.2Concentration typeequal
D.3.10.3Concentration number480 µg (48 MIU)
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 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.IMP: 2
D.1.2 and D.1.3IMP RoleComparator
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 Neupogen(R)
D.2.1.1.2Name of the Marketing Authorisation holderAmgen
D.2.1.2Country which granted the Marketing AuthorisationHungary
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 nameNeupogen(R)
D.3.2Product code Filgrastim
D.3.4Pharmaceutical form 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 INNFilgrastim
D.3.9.2Current sponsor codeNeupogen(R)
D.3.9.3Other descriptive name(r-metHuG-CSF)
D.3.10 Strength
D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
D.3.10.2Concentration typeequal
D.3.10.3Concentration number480 µg (48 MIU
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 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
Patients with small cell or non small cell lung cancer receiving platinum-based chemotherapy and developing Neutropenia due to chemotherapy.
MedDRA Classification
E.1.3Condition being studied is a rare disease Information not present in EudraCT
E.2 Objective of the trial
E.2.1Main objective of the trial
Demonstration of safety of XM 02 when administered for up to a maximum of six cycles in patients with lung cancer.
E.2.2Secondary objectives of the trial
Demonstration of efficacy of XM 02 (in the first cycle compared to Filgrastim) in patients with lung cancer.
Evaluation of pharmacokinetic properties of XM 02 in comparison to Filgrastim.
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
Female and male patients of any ethnic origin with a diagnosis of lung cancer meeting all criteria listed below, will be included in the study.
• Signed and dated written informed consent
• Age ≥18 years
• Patients with small cell lung cancer, histologically or cytologically documented
• Patients with advanced disease non small cell lung cancer
• Patients planned/eligible to receive a platinum-based, myelosuppressive
chemotherapy requiring G-CSF support in the investigator’s opinion
• Life-expectancy of at least 6 months
• Chemotherapy naïve or have received no more than one previous regimen of
chemotherapy
• Completion of previous chemotherapy more than 4 weeks before randomisation
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• ANC ≥1.5 x 109/L
• Platelets ≥100 x 109/L
• Adequate hepatic, cardiac, and renal function for the chosen CTX regimen
E.4Principal exclusion criteria
Patients presenting with any of the following will not be included in the study:
• Participation in a clinical trial within 30 days before randomisation
• Previous exposure to Filgrastim, Pegfilgrastim or Lenograstim
• Patient planned for non-myelosuppressive chemotherapy
• Patient meeting any contraindication for the chosen chemotherapy regimen
• Treatment with systemically active antibiotics within 72 hours before chemotherapy
• Treatment with lithium
• Candidate for combined chemo-/radiotherapy
• Chronic use of oral corticosteroids (except low dose chronic treatment with
≤20 mg/day prednisolone or equivalent dose for chronic obstructive pulmonary
disease)
• Prior radiation therapy within 4 weeks before randomisation
• Prior bone marrow or stem cell transplantation
• Any illness or condition that in the opinion of the investigator may affect the safety of
the patient or the evaluation of any study endpoint
• Pregnant or nursing women are excluded. Women of child-bearing potential must
agree to use a chemical or barrier contraceptive during the treatment period.
E.5 End points
E.5.1Primary end point(s)
Primary evaluation criteria
Safety
• Incidence of adverse events
• Changes of safety laboratory parameters
• Immunogenicity (development of antibodies against study drug)
Secondary evaluation criteria:
Efficacy
• Incidence of febrile neutropenia per cycle and across all cycles (febrile neutropenia
defined as axillary body temperature of ≥38.5°C for more than one hour, and
ANC <0.5 x 109/L)
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• Duration of severe neutropenia (DSN), defined as grade 4 neutropenia with an
ANC <0.5 x 109/L in cycles 1 and 4
• Depth of ANC nadir in cycles 1 and 4
• Times to ANC recovery in cycles 1 and 4
• Mortality
Other
• Pharmacokinetics in a subset of patients
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 Yes
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 Yes
E.6.13.1Other scope of the trial description
comparison with marketed product
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) Yes
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 No
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 Yes
E.8.1.7.1Other trial design description
Blinding by third party.
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Yes
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 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 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 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
Last visit of the last patient undergoing the trial.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years1
E.8.9.1In the Member State concerned months4
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years1
E.8.9.2In all countries concerned by the trial months4
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 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 2004-08-05. 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 state
F.4.2 For a multinational trial
F.4.2.1In the EEA 150
F.4.2.2In the whole clinical trial 240
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)
After end of treatment, safety follow up period for 30 days.
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 Decision2004-09-14
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2004-09-01
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2006-04-19

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