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    Summary
    EudraCT Number:2011-000299-33
    Sponsor's Protocol Code Number:AGO-GYN8
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-24
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2011-000299-33
    A.3Full title of the trial
    Efficacy, tolerability and safety of Temsirolimus in women with platinum-refractory ovarian carcinoma or advanced endometrial carcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Activity, tolerability and safety of Temsirolimus in women with ovarian cancer who progressed during the previous platinum chemotherapy alternatively within 6 months from completion of therapy or advanced endometrial carcinoma
    A.4.1Sponsor's protocol code numberAGO-GYN8
    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 SponsorAGO Research GmbH
    B.1.3.4CountryGermany
    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 organisationAGO Research GmbH
    B.5.2Functional name of contact pointStudy Office
    B.5.3 Address:
    B.5.3.1Street AddressKaiser-Friedrich-Ring 71
    B.5.3.2Town/ cityWiesbaden
    B.5.3.3Post code65185
    B.5.3.4CountryGermany
    B.5.4Telephone number00496118804670
    B.5.5Fax number004961188046767
    B.5.6E-mailoffice-wiesbaden@ago-ovar.de
    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 (R)
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameTORISEL
    D.3.4Pharmaceutical form Concentrate and diluent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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) 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
    platinum-refractory ovarian carcinoma or advanced endometrial carcinoma
    E.1.1.1Medical condition in easily understood language
    patients with ovarian cancer who progressed during the previous chemotherapy or within 6 months after completion of therapy or patients with advanced endometrial carcinoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10014733
    E.1.2Term Endometrial cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10066697
    E.1.2Term Ovarian cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    progression-free survival rate after 4 months (recurrent ovarian cancer) or 6 months (endometrial cancer)
    E.2.2Secondary objectives of the trial
    -rate and duration of stable diseases according to RECIST 1.1 and GCIG-criteria for ovarian cancer and RECIST-criteria for endometrial cancer
    -progression-free survival according to RECIST 1.1 and CA 125 (for ovarian cancer) (PFSbio)
    -overall survival
    -safety and toxicity according to “Common Toxicity Criteria for Adverse Events” (CTCAE), Version 4.0
    -quality of life according to EORTC QLQ C30, QLQ OV28 and QLQ-EN24
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    *women ≥ 18 years
    *ECOG Performance Status ≤ 2
    *Before performance of study specific actions or assessment the patient has to be informed, has signed the written consent and is willing to follow the requirements concerning treatment and follow-up.
    Comment: Procedures which are according to common clinical routine and having been performed before having given written informed consent may be used for the purpose of screening procedures or initial medical assessment as long as these procedures follow the protocol.
    *required: negative pregnancy test in fertile women

    Stratum A – Ovarian Cancer:

    -Histologically confirmed Ovarian Cancer
    -platin-refractory relapsed disease: progression within a platin-based chemotherapy or within 6 months after completion of a platin-based chemotherapy
    -prior treatment with a taxan-based scheme
    -minimum of one measurable or non-measurable tumor lesion (according to RECIST 1.1 criteria)
    -not more than 2 previous chemotherapies or cytostatic therapies (i.e. monoclonal antibodies, cytokines, signal transduction inhibitors)

    Stratum B – Endometrian Cancer:

    -Histologically confirmed Endometrian Cancer
    -advanced (FIGO III or IV) or relapsed diseases not amenable to potentially curative treatment with local surgery and/or radiation therapy
    -prior endocrine therapy is allowed
    -prior adjuvant chemotherapy is allowed
    -minimum of one measurable or non-measurable tumor lesion (according to RECIST 1.1 criteria)
    E.4Principal exclusion criteria
    *ECOG > 2
    *prior therapy with mTOR-Inhibitor
    *cytostatic therapy (i.e. monoclonal antibodies, cytokines, signal transduction inhibitors), cytotoxical chemotherapy or endocrine therapy or radiation at the same time
    *current or recent treatment with another study drug and/or participation in another clinical study within 28 days prior to first dose of study treatment
    * chemotherapy or cytostatic therapy (i.e. monoclonal antibodies, cytokines, signal transduction inhibitors) or radiation within 28 days prior to start of study treatment
    *known or supposed hypersensitivity compared to study medication
    *acute or chronical infection
    *Second malignancy which influences the prognosis of the patient
    *inadequate renal function (Creatinin >1.5 x ULN)
    *inadequate liver function (AST, ALT, GGT >2.5 x ULN or >5.0 x ULN in the presence of liver metastasis; Bilirubin >1.5 x ULN)
    *platelets < 100.000 /μl; ANC < 1.500 /μl
    *cachectic patients with weight < 45kg
    *patients who need parenteral nutrition
    *patients with ileus within the last 28 days
    *one of the following diseases within 12 months prior to first study treatment: myocardial infarction, severe/unstable angina, bypass-surgery of the coronar- or peripheral vessels, symptomatic heart insufficiency, cerebrovascular insult, transient ischemic attack (TIA), pulmonary embolism, deep venous thrombosis, other thromboembolic events
    *current treatment with CYP3A4-Inhibitors (i.e. protease inhibitors, antimycotics, calcium channel blocker, macrolide antibiotics, Cimetidin) or -inductors (i.e. Carbamazepin, Phenobarbital, Phenytoin, Rifampicin, amber)
    *uncontrolled hypertension (>150/100 mmHg despite optimal medicinal treatment)
    *current cardiac arrhythmias (NCI CTCAE grade ≥2), atrial fibrillation, prolongation of QTc >470 msec
    *left ventricular ejection fraction (LVEF) ≤50% defined by ECHO
    *NCI CTCAE grade 3 hemorrhage within 4 weeks prior to beginning of treatment
    *symptoms which indicate brain metastases, spinal cord compression or give new indications for brain- or leptomeningeal metastases
    *HIV positive or manifested AIDS-disease
    *patients with other severe diseases who represent an inadequate risk for study participation

    Applicable only for patients with no hysterectomy and/or bilateral adnexectomy prior to start of study.

    *lactation
    *potential fertile women without adequate contraception (potential fertile women must use one of the following adequate contraception: complete abstinence, intrauterine spiral or another method with a failure quote <1% per year)
    *life expectancy <3 months
    *neurological or psychiatric diseases or drugs or alcohol abuse which suppose no adequate comprehension and consequently no effective consent to study participation or no acceptable compliance during the study
    *predictable problems with the compliance to appointments for examinations
    E.5 End points
    E.5.1Primary end point(s)
    Ovarian Cancer:
    after 16 weeks under treatment with Temsirolimus the probability of progression free survival must have a minimum of 40%

    Endometrial Cancer:
    after 24 weeks under treatment with Temsirolimus the probability of progression free survival must have a minimum of 40%
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ovarian Cancer: 16 weeks after start of treatment of the last patient

    Endometrial Cancer: 24 weeks after start of treatment of the last patient
    E.5.2Secondary end point(s)
    Rate and duration of disease stabilization
    Progression-free survival according to RECIST 1.1 and CA 125 (PFSbio)
    Overall survival
    Safety and toxicity profile
    Quality of Life
    E.5.2.1Timepoint(s) of evaluation of this end point
    Intervals are every 8 weeks until disease progression
    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 Yes
    E.6.13.1Other scope of the trial description
    quality of life measures (EORTC C30, OV28, EN24)
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 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.8.4.1Number of sites anticipated in Member State concerned19
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state86
    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)
    All patients, who have completed their treatment or their study participation will be followed up as any other patient. In case of progression of disease decisions on further treatment in response to progression shall be at the physicians discretion.
    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 Decision2011-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
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