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    Summary
    EudraCT Number:2011-002149-36
    Sponsor's Protocol Code Number:G-202-002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-07-09
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-002149-36
    A.3Full title of the trial
    An Open-Label, Single-Arm, Phase 2 Study of G-202 in Patients with Chemotherapy-Naïve Metastatic Castrate-Resistant Prostate Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 study of G-202 in patients with castrate-resistant prostate cancer that has metastasized (spread) and has not been treated previously with chemotherapy.
    A.4.1Sponsor's protocol code numberG-202-002
    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 SponsorGenSpera, Inc.
    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 supportGenSpera, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNexus Oncology Ltd
    B.5.2Functional name of contact pointProject Manager G-202-002
    B.5.3 Address:
    B.5.3.1Street AddressRoslin Biocentre
    B.5.3.2Town/ cityRoslin, Midlothian
    B.5.3.3Post codeEH25 9TT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44131200 6320
    B.5.5Fax number+44131200 6322
    B.5.6E-mailcontact@nexusoncology.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 nameG-202
    D.3.2Product code G-202
    D.3.4Pharmaceutical form Powder and solvent 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 INNG-202
    D.3.9.2Current sponsor codeG-202
    D.3.9.3Other descriptive nameThapsigargin prodrug
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.3.11.13.1Other medicinal product typeThapsigargin prodrug, a chemically modified natural product of plant origin
    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
    chemotherapy-naïve metastatic castrate-resistant prostate cancer
    E.1.1.1Medical condition in easily understood language
    prostate 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 PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    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 percentage of patients with chemotherapy-naïve metastatic castrate-resistant prostate cancer who do not have disease progression (radiographic or clinical) after 24 weeks of treatment with G-202.
    E.2.2Secondary objectives of the trial
    Investigate the safety profile and clinical activity of G-202 administered by intravenous infusion daily for 3 consecutive days on a 28-day cycle in patients with chemotherapy-naïve metastatic castrate-resistant prostate cancer.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically- or cytologically-confirmed prostate adenocarcinoma

    2. Evidence of radiographic metastatic or recurrent disease. The presence of sclerotic lesions seen on CT scans that are equivocal on the bone will be allowed if the investigator considers these to be metastases

    3. Chemically- or surgically-castrated patient with documented disease progression as evidenced by one or more of the following three criteria:
    - Rising PSA, defined according to PCWG2 criteria
    - Nodal or visceral progression
    - Evidence of progression of bone metastases

    4. In patients who have undergone chemical castration, a castrate testosterone level <50 ng/dL within 4 weeks prior to initiation of G-202 treatment and patient agrees to stay on a luteinizing hormone releasing hormone (LHRH) agonist or antagonist medication for the duration of the study

    5. If on LHRH therapy, must have been on this therapy for at least 3 months prior to study entry

    6. For any patient previously treated with flutamide (Eulixin®), nilutamide (Nilandron®), or bicalutamide (Casodex®):
    - Patient treated with flutamide must have discontinued flutamide 4 weeks prior to registration with continued evidence of progressive disease (progressive metastatic or recurrent disease or rising PSA after the discontinuation period)
    - Patient treated with bicalutamide or nilutamide must have discontinued the drug ≥ 6 weeks prior to registration with evidence of progressive disease (progressive metastatic or recurrent disease or rising PSA after the discontinuation period)

    7. Absence of known brain metastases (confirmation by CT and/or MRI not required)

    8. Age ≥18 years at the time of enrollment

    9. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

    10. Estimated life expectancy of ≥ 6 months

    11. Adequate hematopoietic function as demonstrated by:
    - hemoglobin of ≥ 9.0 g/dL without need for sustained blood transfusions
    - platelet count ≥100,000 platelet/mm3 (100 x 109/L)
    - WBC count ≥ 2.0 x109/L and ANC ≥1.5 x109/L

    12. Adequate hepatobiliary function as demonstrated by:
    - Total bilirubin level ≤1.5 times the upper limit of normal (ULN), unless the patient has Gilbert’s syndrome in which case the patient must have a total bilirubin level ≤ 2.5 x ULN
    - alanine aminotransferase (ALT) levels ≤ 2.5 x ULN

    13. Adequate renal function as demonstrated by creatinine level ≤1.5 x ULN or creatinine clearance (measured or calculated by Cockcroft-Gault formula) ≥ 50mL/min

    14. Acceptable coagulation profile (PT or INR, PTT < 1.5 x ULN)

    15. If of reproductive capacity, willing to use an effective double barrier method of birth control (i.e., latex condom, diaphragm, cervical cap, etc) during the study and for 30 days after the last administration of G-202

    16. Ability to understand and willingness to sign a written informed consent document

    17. Agree to adhere to the study visit schedule
    E.4Principal exclusion criteria
    1. Prior chemotherapy for treatment of metastatic or recurrent prostate cancer

    2. Other concurrent therapy for prostate cancer other than LHRH agonists or antagonists. LHRH agonists or antagonists must have been taken at a steady dose for at least 3 months prior to study entry. The following must be discontinued and cannot be taken within 4 weeks of study entry: 5α-reductase inhibitors (e.g., finasteride, dutasteride), ketoconazole (if given for more than 7 days), aminoglutethimide, megestrol, diethylstilbestrol (DES), abiraterone acetate, MDV3100 (enzalutamide), TAK700, sipuleucel-T. Replacement doses of glucocorticoids are allowed; but chronic daily use of glucocorticoids for prostate cancer is not allowed

    3. Treatment with therapeutic radionucleotides, such as strontium chloride (Sr89), samarium (Sm153) lexidronam pentasodium, or radium-223 within 12 weeks of study entry

    4. Radiation therapy < 4 weeks before study entry or not recovered from side effects of prior radiotherapy

    5. Known brain metastases (CT or MRI not required)

    6. Documentation of keratosis follicularis, also known as Darier or Darier-White disease.

    7. Known hypersensitivity to any study drug component, including thapsigargin derivatives, polysorbate 20 or propylene glycol.

    8. Pre-existing cardiac condition:
    - Documented myocardial infarction within 6 months of study entry
    - Pre-existing cardiac failure (NYHA class III-IV)
    - Atrial fibrillation on anti-coagulants (baby aspirin allowed)
    - Unstable angina
    - Severe valvulopathy causing significant symptoms of heart failure (class III-IV)
    - Cardiac angioplasty or stenting within the last 6 months

    9. Requirement for use of inhibitors or inducers of cytochrome (CYP3A4) iso-enzymes as described in Appendix IV.

    10. Chronic use of moderate or strong opioids for cancer-related pain

    11. The patient has a QTc value > 470 msec (Appendix V)

    12. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study

    13. Active uncontrolled infection, including known history of AIDS, hepatitis B or C

    14. Proteinuria level > +2 on urine analysis

    15. Any psychological condition or geographical situation that could potentially interfere with compliance with the study protocol and follow-up schedule.

    16. The patient is or is expected to be concurrently receiving any other investigational agents while on study
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients who are progression-free after 24 months of treatment with G-202.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Radiographic disease progression is measured every 12 weeks. Clinical symptoms of progression are measured on an ongoing basis throughout the study.
    E.5.2Secondary end point(s)
    1. Maximum PSA change from baseline at any time
    2. Percent change in PSA level from baseline to 24 weeks
    3. Time to PSA progression by PCWG 2 criteria.
    4. PSA doubling time.
    5. Best objective response rate (i.e., the percentage of patients with measureable visceral and/or nodal metastatic disease at baseline who achieve complete or partial response) at any time point after initiation of G-202 treatment as assessed by the PCWG2 criteria.
    6. Time to disease progression (clinical or radiographic).
    7. Progression-free survival time.
    8. Proportion of patients experiencing treatment emergent adverse events, according to NCI Common Toxicity Criteria, version 4.03
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - 4. PSA measured at screening, day 1 of treatment cycles after cycle 1, and at the 30 day follow up.
    5 & 6. Radiographic progression measured by CT and bone scan at screening and repeated every 12 weeks throughout the duration of the study. Clinical assessments for progression are performed on an ongoing basis during the course of clinic visits for the duration of the study.
    7. Timepoints not applicable for survival data as recorded on ongoing basis.
    8. AEs collected on ongoing basis for the duration of the study.
    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 Yes
    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) 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 Yes
    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 concerned2
    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 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
    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
    LVLS
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 40
    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)
    Normal standard of care
    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 Decision2012-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-08-19
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