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    Summary
    EudraCT Number:2009-015498-11
    Sponsor's Protocol Code Number:3066K1-4438/B1771007
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-14
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2009-015498-11
    A.3Full title of the trial
    A Randomized Phase 4 Study Comparing 2 Intravenous Temsirolimus (TEMSR) Regimens in Subjects With Relapsed, Refractory Mantle Cell Lymphoma
    Randomizované klinické hodnocení fáze 4, porovnávající 2 intravenózní režimy podávání temsirolimu (TEMSR) u subjektů s relabujícím, refrakterním lymfomem z plášťových buněk (mantle cell)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of two doses of Temsirolimus (Torisel) in patients with relapsed mantel cell lymphoma.
    A.4.1Sponsor's protocol code number3066K1-4438/B1771007
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01180049
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorWyeth Pharmaceuticals Inc, a wholled owned subsidiary of Pfizer Inc, 500 Arcola Road, Collegeville, PA 19426 USA
    B.1.3.4CountryUnited States
    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 supportWyeth Pharmaceuticals Inc, a wholled owned subsidiary of Pfizer Inc, 500 Arcola Road, Collegeville, PA 19426 USA
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+0018007181021
    B.5.5Fax number+0013037391119
    B.5.6E-mailClinicalTrials.govCallCenter@pfizer.com
    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 TORISEL 25 mg/ml concentrate and diluent for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa Limited
    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 numberODDN for MCL = EU/3/06/420
    D.3 Description of the IMP
    D.3.1Product nameTORISEL
    D.3.2Product code PF-05208748
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTEMSIROLIMUS
    D.3.9.1CAS number 162635-04-3
    D.3.9.2Current sponsor codeCCI-779
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 Yes
    D.2.1.1.1Trade name Nortimil
    D.2.1.1.2Name of the Marketing Authorisation holderCHIESI FARMACEUTICI S.p.A
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNDESIPRAMINE
    D.3.9.1CAS number 50475
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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: 3
    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 Desipramine Hydrochloride Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderEpic Pharma, LLC
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNDESIPRAMINE
    D.3.9.1CAS number 50-47-5
    D.3.9.4EV Substance CodeSUB06995MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Relapsed Refractory Mantle Cell Lymphoma
    E.1.1.1Medical condition in easily understood language
    Relapsed, refractory mantle cell lymphoma.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10026801
    E.1.2Term Mantle cell lymphoma refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Estimate independently assessed progression free survival (PFS) in subjects with relapsed, refractory MCL.
    E.2.2Secondary objectives of the trial
    • Estimate Overall Survival.
    • Estimate objective response rate, independently and investigator assessed.
    • Estimate investigator assessed PFS.
    • Assess safety, including adverse events of infection and bleeding.
    • Quantify the potential effect of TEMSR to alter the disposition of desipramine, a substrate of CYP2D6 metabolism.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subject must meet all of the following criteria to be enrolled in the study:
    1. MCL confirmed locally with histology, immunophenotype, and cyclin D1 analysis.
    2. Male or female subjects aged 18 years or older.
    3. Refractory to or relapsed from 2 to 7 prior therapies, which may include HSCT (ie, induction + consolidation + maintenance).
    4. Prior treatment with an alkylating agent and an anthracycline and rituximab, individually or in combination.
    5. Measurable disease in an area of no prior radiotherapy or clear progression in an area that was previously irradiated
    6. Adequate organ and marrow function obtained within 2 weeks prior to first dose administration of TEMSR as defined by the following:
    • Absolute neutrophil count (ANC) ≥ 1,000/μL
    • Platelet (PLT) ≥75,000/μL (≥ 50,000/μL is allowed if with bone marrow involvement)
    • Hemoglobin ≥ 8 g/dL
    • Total bilirubin ≤ 1.5 x upper limit normal (ULN) (if abnormal, direct bilirubin must be ≤ 1.5 x ULN)
    • Aspartate aminotransferase (AST) ≤ 3 x ULN (≤ 5 x ULN is allowed if with liver involvement)
    • Serum creatinine ≤ 2 x ULN
    • Fasting serum cholesterol ≤ 350 mg/dL (9.01 mmol/L)
    • Triglycerides ≤ 400 mg/dL (4.5 mmol/L)
    • Glycosylated hemoglobin (Hgb A1c) <10% (optimal therapy permitted)
    • Other laboratory values all common toxicity criteria (CTC) version 3.0 grade ≤ 2 unless related to lymphomatous organ involvement.
    7. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
    8. For women of child bearing potential, a negative serum pregnancy test prior to first dose administration of any investigational agen (ie: Desipramine and/or TEMSR). Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
    E.4Principal exclusion criteria
    Presence of any of the following criteria will exclude the subject from enrollment in the study:
    1. Subjects who are ≤ 6 months from allogeneic HSCT and who are on immunosuppressive therapy or have evidence of graft host disease.
    2. Prior investigational therapy within 3 weeks before first infusion of TEMSR. Investigational therapy is defined as treatment that is not approved for any indication.
    3. Treatment within the following time frame relative to first dose administration of TEMSR:
    • Chemotherapy, radiotherapy, immunotherapy, or major surgery ≤ 3 weeks
    • Nitrosourea or mitomycin ≤ 6 weeks
    • Radioimmunotherapy ≤ 8 weeks
    • Other nonmyelosuppressive biological response modifiers < 2 weeks.
    4. Active central nervous system (CNS) metastases. Subjects with brain metastases are eligible as long as they are clinically stable prior to first dose administration of TEMSR (no significant changes in anticonvulsant doses, mental status,or clinical symptoms related to CNS metastases) after completion of definitive therapy.
    5. Current active second malignancy other than nonmelanoma skin cancers and clinically localized prostate cancer. Subjects are not considered to have a currently active malignancy if they have completed anti-cancer therapy with curative intent and are disease-free at least 2 years prior to first dose administration of TEMSR. Subjects with a history of cervical carcinoma in situ, breast ductal carcinoma in situ, or breast lobular carcinoma in situ are considered eligible provided they have completed definitive therapy.
    6. Any prior history of noninfectious interstitial pneumonitis / interstitial lung disease.
    7. Subjects who are receiving desipramine or have an intolerance to desipramine or other tricyclic antidepressants. (this criterion pertains only to subjects who are participating in the desipramine/PK sub-study)
    8. Prior treatment with TEMSR or other mTOR inhibitor.
    9. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality or cardiac dysfunction that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    10. Previous history of hypersensitivity to TEMSR, its metabolites (including sirolimus), polysorbate 80, or any other components of TEMSR formulation.
    11. Hypersensitivity to antihistimines or subjects who cannot receive antihistimines for other medical reasons.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS) based on blinded, independent tumor assessments will be the primary endpoint of this study. PFS is defined as the time from randomization to progressive disease or death.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Independentally assessed Progression Free Survival (PFS). Tumor assessments every 6-12 wks. Primary analysis approx. 69 PFS events.
    E.5.2Secondary end point(s)
    Secondary endpoints include PFS per the investigator assessment and ORR per independent assessment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival, objective response rate, investigator assessed PFS, and safety (including AE's of infection and bleeding), affect of TEMSR to alter the disposition of Desipramine.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Drug interaction with desipramine
    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 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
    Temsirolimus lower dosage arm (75 mg IV weekly regimen)
    E.8.2.4Number of treatment arms in the trial2
    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 Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Bulgaria
    Czech Republic
    France
    Germany
    Hong Kong
    Hungary
    India
    Italy
    Korea, Republic of
    Netherlands
    Poland
    Romania
    Russian Federation
    Serbia
    E.8.7Trial has a data monitoring committee Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 74
    F.4.2.2In the whole clinical trial 100
    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)
    Follow up every 3 months from last dose of TEMSR.
    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 Decision2012-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-28
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