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    Summary
    EudraCT Number:2012-000639-16
    Sponsor's Protocol Code Number:9090-09
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-08
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-000639-16
    A.3Full title of the trial
    A Single Arm, Phase 2 Study of Ganetespib in Subjects with Advanced Non- Small-Cell Lung Cancer with Anaplastic Lymphoma Kinase Gene Rearrangement (ALK-Positive NSCLC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of an investigational drug (Ganetespib) in patients with advanced lung cancer whose cancer has a specific genetic make-up
    A.4.1Sponsor's protocol code number9090-09
    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 Corp
    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 pointSr Clinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street Address45 Hartwell Avenue
    B.5.3.2Town/ cityLexington
    B.5.3.3Post code02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number001781274-8200
    B.5.5Fax number001781274-8228
    B.5.6E-mail9090-09_StudyInfo@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.3.4Pharmaceutical 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.3.9.1CAS number 888216-25-9
    D.3.9.2Current sponsor codeganetespib
    D.3.9.3Other descriptive nameSTA-9090
    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.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
    AKL positive advanced non-small cell lung cancer
    E.1.1.1Medical condition in easily understood language
    Advanced 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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10025054
    E.1.2Term Lung cancer non-small cell stage IIIB
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    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
    Determine the objective response rate (ORR) of ganetespib in subjects with advanced ALK-positive NSCLC
    E.2.2Secondary objectives of the trial
    Determine the overall progression-free survival (PFS), 6-month PFS and 1-year PFS.
    • Determine duration of response.
    • Determine the overall survival (OS) and 1-year OS.
    • Determine the disease control rate (DCR) at weeks 6 and 12.
    • Determine the change in tumor size (CTS) at weeks 6 and 12.
    • Evaluate the qualitative and quantitative toxicities associated with ganetespib in
    subjects with ALK-positive NSCLC.
    • Evaluate symptom improvement using Functional Assessment of Cancer Therapy
    – Lung (FACT-L) version 4.
    • Determine the relationship of clinical outcome with relevant biomarkers and genetic changes present in tumor tissues and serum samples.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Males or females aged 18 years or older
    2 Pathological confirmation (by histology or cytology) of advanced NSCLC
    a. De novo disease (i.e., 0 lines of prior therapy; stage IIIB or IV NSCLC according to the AJCC Cancer Staging Manual 7th Edition 2010
    Or
    b. Recurrent disease with up to 3 lines of prior systemic therapy (i.e., 1-3)
    3 Histological confirmation of adenocarcinoma
    4 Evidence of a translocation or an inversion event involving the ALK gene locus as determined by either a local or central laboratory, or prior documentation of ALKpositive status by a local laboratory
    5 Availability of recent tumor tissue or a minimum of 10 slides of archived tumor tissue is required for ALK rearrangement confirmation testing and evaluating relevant biomarkers.
    6 ECOG Performance Status 0 or 1
    7 Adequate hematologic, hepatic and renal function (as defined in the protocol)
    E.4Principal exclusion criteria
    1. Prior therapy with crizotinib
    2. Prior therapy with other ALK-targeted agents
    3. Prior treatment with any Hsp90 inhibitor
    4. Known EGFR activating mutation
    5. Presence of active or untreated central nervous system (CNS) metastases as determined by magnetic resonance imaging (MRI) or computed tomography (CT) scan performed during screening or individuals who have been treated for CNS metastasis and discontinued the steroid treatment less than 4 weeks prior to Cycle 1 Day 1
    6. Active malignancies other than NSCLC within the previous 2 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
    7. Known serious cardiac illness (see protocol for details)
    8. Prior radiotherapy to the only area of measurable disease
    9. Radiotherapy within 2 weeks prior to Cycle 1 Day 1 (related radiotherapy toxicities must be ≤ Grade 1)
    10. Major surgery (unrelated to NSCLC) within 4 weeks prior to Cycle 1 Day 1
    11. Women who are pregnant or lactating
    12. Significant weight loss (≥10% body weight) within the 4 weeks prior to Cycle 1 Day 1
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate (ORR) (the proportion of subjects showing a complete or partial response).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis of ORR will be conducted 3 months after the last subject is enrolled
    E.5.2Secondary end point(s)
    Progression Free Survival (PFS)
    Duration of Response (DOR)
    Overall Survival (OS)
    Disease Control Rate (DCR)
    Change in Tumor Size (CTS)
    Adverse Events
    Symptom improvement outcome
    Correlative Biomarker Analyses
    Laboratory Data
    Other Safety Parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    The PFS rate at 6 months and 1 year
    The OS rate at 1 year
    DCR is measured at weeks 6 and 12
    CTS is measured from baseline to at least 6 weeks (CTS-6) or 12 weeks (CTS-12)
    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 Yes
    E.6.11Pharmacogenomic Yes
    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) 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 Information not present in EudraCT
    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.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Bosnia and Herzegovina
    Canada
    Croatia
    France
    Germany
    Serbia
    Spain
    United Kingdom
    United States
    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
    End of trial is last survival follow-up of last patients (patients will be followed for survival for up to 3 years)
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    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: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 110
    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)
    Patients should follow normal standard of care for treatment
    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 Decision2012-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-04
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