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    Summary
    EudraCT Number:2012-004349-34
    Sponsor's Protocol Code Number:9090-14
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-02-08
    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 number2012-004349-34
    A.3Full title of the trial
    A RANDOMIZED, PHASE 3 STUDY OF GANETESPIB IN COMBINATION WITH DOCETAXEL VERSUS DOCETAXEL ALONE IN PATIENTS WITH ADVANCED NON-SMALL-CELL LUNG ADENOCARCINOMA
    Randomizovaná studie fáze 3 hodnotící kombinaci Ganetespibu s Docetaxelem ve srovnání se samostatně podávaným Docetaxelem u pacientů s pokročilým nemalobuněčným adenokarcinomem plic.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A RANDOMIZED, PHASE 3 STUDY OF GANETESPIB IN COMBINATION WITH DOCETAXEL VERSUS DOCETAXEL ALONE IN PATIENTS WITH ADVANCED NON-SMALL-CELL LUNG ADENOCARCINOMA
    A.3.2Name or abbreviated title of the trial where available
    Galaxy-2
    A.4.1Sponsor's protocol code number9090-14
    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 SponsorSynta Pharmaceuticals Corporation
    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 supportSynta Pharmaceuticals Corp.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSynta Pharmaceuticals Corp.
    B.5.2Functional name of contact pointMedical Officer
    B.5.3 Address:
    B.5.3.1Street Address45 Hartwell Avenue
    B.5.3.2Town/ cityLexington, Massachusetts
    B.5.3.3Post code02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1781541-71-92
    B.5.5Fax number+1781541-71-41
    B.5.6E-mailfteofilovici@syntapharma.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 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.3.1Product nameGanetespib
    D.3.2Product code STA-9090
    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 INNGanetespib
    D.3.9.1CAS number 888216-25-9
    D.3.9.2Current sponsor codeSTA-9090
    D.3.9.3Other descriptive nameGANETESPIB
    D.3.9.4EV Substance CodeSUB88334
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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: 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 Yes
    D.2.1.1.1Trade name Docetaxel Actavis 20 mg/mL concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC ehf.
    D.2.1.2Country which granted the Marketing AuthorisationRomania
    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 nameDocetaxel
    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 INNdocetaxel
    D.3.9.1CAS number 114977-28-5
    D.3.9.3Other descriptive nameDOCETAXEL
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    ADVANCED NON-SMALL-CELL LUNG ADENOCARCINOMA
    E.1.1.1Medical condition in easily understood language
    ADVANCED NON-SMALL-CELL LUNG CANCER
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10025038
    E.1.2Term Lung adenocarcinoma stage IV
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10025037
    E.1.2Term Lung adenocarcinoma stage III
    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
    Compare OS in NSCLC patients with adenocarcinoma histology treated with ganetespib in combination with docetaxel versus docetaxel alone
    E.2.2Secondary objectives of the trial
    • Compare progression-free survival (PFS) between the 2 treatment arms
    • Compare OS between the 2 treatment arms in patients with elevated screening serum lactate
    dehydrogenase (eLDH) levels.
    • Compare ORR, DCR, and DOR between the 2 treatment arms
    • Compare PFS, ORR, and DCR between the 2 treatment arms in patients with screening serum eLDH levels.
    • Compare the emergence of metastatic lesions between the 2 treatment arms
    • Evaluate the safety of study treatments in this patient population
    • Compare patient quality of life as measured EQ-5D-3L test between the 2 treatment arms
    • Compare symptom improvement as measured by the Functional Assessment of Cancer Therapy – Lung (FACT-L) version 4 test between the 2 treatment arms
    • Assess the correlation between biomarkers, including KRAS status, and clinical outcome
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 years or older
    2. Pathologically confirmed diagnosis of NSCLC, with predominantly adenocarcinoma histology. Tumors must be negative for both EGFR mutations and ALK translocations.
    3. Advanced (Stage IIIB/IV) NSCLC
    4. Only 1 prior systemic therapy for advanced disease defined as a platinum-based combination chemotherapy
    NOTE: Prior neoadjuvant or adjuvant therapy for completely resected Stage I, II, or IIIA disease is allowed.
    NOTE: Maintenance therapy with approved, standard-of-care drugs (eg, pemetrexed, bevacizumab) is allowed provided that it was started no more than 6 weeks after the last dose of prior cancer therapy and there was no evidence of disease progression.
    5. Diagnosis of advanced NSCLC ≥6 months prior to signing of informed consent document
    6. Documented disease progression during or following first-line therapy for advanced disease
    7. Measurable disease
    8. Available archived tumor tissue block with sufficient tumor tissue for biomarker testing; alternatively unstained slides with sufficient tumor tissue may be substituted. If archived tissue is not available, a fresh biopsy will be obtained during the screening period.
    9. ECOG PS 0 or 1
    NOTE: With PS 1 on ECOG scale, patients must be scored ≥80 on Karnofsky Performance Status (KPS) scale
    10. Adequate hematologic function defined as:
    • Absolute neutrophil count (ANC) ≥1.5 × 109/L
    • Hemoglobin ≥9 g/dL
    • Platelets ≥100 × 109/L
    11. Adequate hepatic function defined as:
    • Albumin ≥3 g/dL
    • Serum total bilirubin ≤1.5 × ULN
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 × ULN without liver metastases; ≤5 × ULN if documented liver metastases
    12. Adequate renal function defined as:
    • Serum creatinine ≤1.5 × ULN or calculated creatinine clearance (cCrCl) per Cockcroft-Gault formula ≥ 50mL/min
    13. Negative serum human chorionic gonadotropin pregnancy test at study entry for patients of childbearing potential. Patients of reproductive potential must agree to use adequate contraception for the duration of study treatment and for 30 days after the last dose of ganetespib, and for 3 months (women) and 6 months (men) after the last dose of docetaxel since docetaxel can have genotoxic effects and may alter male fertility.
    14. Ability to understand, and willingness to sign, a written informed consent document and to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
    E.4Principal exclusion criteria
    1. Predominantly squamous, adenosquamous histology, or unclear histologic type
    2. Prior maintenance therapy with an investigational anticancer agent
    3. Prior treatment with tyrosine kinase inhibitors (TKIs) for lung cancer.
    4. Patients with tumors known to harbor molecular alterations for which a targeted therapy is approved.
    NOTE: Patients whose tumors have not been tested for molecular alterations for which a targeted therapy is approved are not eligible.
    5. Presence or suspicion of central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis as determined by magnetic resonance imaging/computed tomography (MRI/CT) scan performed at screening.
    NOTE: Patients who have stable CNS metastases for at least 2 weeks following completion of radiotherapy are eligible
    6. Active malignancies other than NSCLC within the last 5 years except for adequately treated in situ carcinoma of the cervix uteri, or basal or squamous cell carcinoma of the skin
    7. Significant weight loss defined as ≥10% body weight within the 4 weeks prior to randomization
    8. History of pulmonary hemorrhage or hemoptysis National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 2 within 4 months of randomization
    9. Peripheral neuropathy NCI CTCAE ≥Grade 2 at baseline
    10. Patients with only 1 measurable lesion that was exposed to prior radiotherapy; the exception is lesions with documented disease progression with new tissue growth of at least 1 cm in longest diameter compared to nadir scan.
    NOTE: Patients must have completed treatment and recovered from all acute treatment-related toxicities prior to administration of first dose of study drug
    11. Known serious cardiac illness or medical conditions, including but not limited to:
    i. Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker
    ii. Ventricular tachycardia or a supraventricular tachycardia that requires treatment with a Class Ia antiarrhythmic drug (eg, quinidine, procainamide, disopyramide) or Class III antiarrhythmic drug (eg, sotalol, amiodarone, dofetilide). Use of other antiarrhythmic drugs is permitted.
    iii. Use of medications that have been linked to the occurrence of torsades de pointes
    iv. Second- or third-degree atrioventricular (AV) block unless treated with a permanent pacemaker
    v. Complete left bundle branch block (LBBB)
    vi. History of long QT Syndrome or a family member with this condition
    vii. QTc >470 ms (average of triplicate ECG recordings). A consistent method of QTc calculation must be used for each patient’s QTc measurements. QTcF (Fridericia’s formula) is preferred.
    viii. Serum potassium, magnesium, or calcium levels outside the laboratory’s reference range
    12. Uncontrolled intercurrent illness including, but not limited to, patients receiving combination antiretroviral therapy or patients with severe or systemic infection, or psychiatric illness/social situations that would limit compliance with study
    requirements.
    13. Other severe acute/chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study.
    NOTE: Patients with a history, or at a risk, of pulmonary embolism are eligible with appropriate use of anti-coagulant therapy.
    NOTE: Patients cannot receive other investigational treatments while on treatment in this study. If a patient has participated in an interventional clinical trial, a minimum of 30 days or 5 half-lives must elapse before randomization into this study.
    14. Women who are breastfeeding
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is OS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final OS analysis will be performed when approximately 560 deaths have been observed
    E.5.2Secondary end point(s)
    The key secondary endpoints for this study are the PFS for all randomized patients and OS for patients with eLDH. Other secondary endpoints:
    - ORR, DCR, Duration of Response (DOR), emergence of new metastatic lesions
    E.5.2.1Timepoint(s) of evaluation of this end point
    OS in eLDH will be analyzed in a similar fashion as the primary efficacy analysis except the stratification variable for LDH will not be used in stratified analyses.
    - PFS, where progression assessed at the investigative site is the interval from the date of randomization until tumor progression
    - ORR is the proportion of patients who achieve tumor response (CR or PR) per modified RECIST 1.1.
    - DCR is defined as the proportion of patients with best response, according to modified RECIST 1.1, of CR, PR, or SD.
    - Duration of Response (DOR) is measured from the time measurement criteria are first met for CR/PR per modified RECIST 1.1 until the first date that recurrent or PD is objectively documented.
    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 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 No
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ganetespib+docetaxel vs docetaxel alone
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA152
    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
    Austria
    Belgium
    Bosnia and Herzegovina
    Canada
    Croatia
    Czech Republic
    France
    Germany
    Hungary
    Poland
    Romania
    Russian Federation
    Serbia
    Slovenia
    Spain
    Ukraine
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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 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.1.2.1Number of subjects for this age range: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 650
    F.4.2.2In the whole clinical trial 850
    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 of care
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-10-21
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