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    Summary
    EudraCT Number:2008-006384-37
    Sponsor's Protocol Code Number:NP22383
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-07-20
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2008-006384-37
    A.3Full title of the trial
    A phase II study of orally administered RO4929097, a gamma-secretase inhibitor, as a single agent in patients with recurrent or refractory Non-Small Cell Lung Cancer (NSCLC).
    A.4.1Sponsor's protocol code numberNP22383
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 namegamma-secretase inhibitor
    D.3.2Product code RO4929097/F01
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNnot yet available
    D.3.9.2Current sponsor codeRO4929097
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 namegamma-secretase inhibitor
    D.3.2Product code RO4929097/F02
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNnot yet available
    D.3.9.2Current sponsor codeRO4929097
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 namegamma-secretase inhibitor
    D.3.2Product code RO4929097/F03
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNnot yet available
    D.3.9.2Current sponsor codeRO4929097
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Patients with recurrent or refractory stage IIIB/IV NSCLC.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029515
    E.1.2Term Non-small cell lung cancer recurrent
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of RO4929097 on tumor blood flow and tumor metabolic activity.
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of RO4929097 on defined pharmacodynamic (PD) parameters.
    To evaluate the pharmacokinetic profile of RO4929097, assessed in the first two cycles of therapy.
    • To characterize overall safety and tolerability of RO4929097 in this patient population
    • To evaluate RO4929097 anti-tumor activity in this indication, assessed by Response rate (RECIST) and Time to tumor progression (TTP)
    • To perform an exploratory analysis of both baseline response-predictive markers and PD markers.
    Exploratory Objectives
    The Roche Clinical Repository (RCR) will be used to:
    • Study the association of biomarkers with efficacy and / or adverse events associated with medicinal products; and/ or
    • Increase knowledge and understanding of disease biology; and/or
    • Develop biomarker or diagnostic assays and/or establish the performance characteristics of these assays
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent
    2. Patient ability to comply with protocol requirements (visits and assessment schedules).
    3. Stage IIIB/IV histologically-confirmed NSCLC that is recurrent or refractory to at most 2 lines of therapy for metastatic disease. Therapy is limited to:
    • First line - platinum containing regimen - bevacizumab
    • Second line - Single-agent EGFR targeted therapies. Acceptable agents include either smallmolecule tyrosine kinase inhibitors (i.e. gefitinib or erlotinib) or monoclonal antibodies. Acceptable agents include either smallmolecule tyrosine kinase inhibitors (i.e. gefitinib or erlotinib) or monoclonal antibodies.
    Other therapies are not allowed.
    4. Patients must have a measurable disease by contrast enhanced CT and detectable by PET scanning. Screening tumor evaluation should be performed within 7 days before the first study drug administration. The Investigator/designee with assess the PET and CT scans to confirm patient eligibility.
    5. Adult patients aged ≥18 yrs.
    6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
    7. Adequate liver function: Total bilirubin ≤ 1.5 mg/dL, AST and ALT ≤ 2.5x institutional ULN (or ≤ 5 x ULN if liver metastases present); alkaline phosphatase ≤ 2.5x ULN (or ≤ 5 x ULN if liver or bones metastases present).
    8. Adequate renal function: serum creatinine ≤ 1.5 mg/dL or creatinine clearance estimate ≥ 45 mL/min (according to Cockroft-Gault formula)
    9. Adequate bone marrow function, defined by: ANC ≥ 1.5 x 10 exp9/L, platelets ≥ 100 x 10 exp9/L, and hemoglobin ≥ 8.5 g/dL. Patients should not require chronic supportive growth factor administration or transfusions to meet treatment eligibility criteria (e.g., G-CSF for ANC eligibility).
    10. Women of child-bearing potential and women less than 2 years after menopause must have a negative urine pregnancy test result within 72 hours prior to the start of study drug administration.
    E.4Principal exclusion criteria
    1. Treatment with any investigational agent within 28 days of first receipt of study drug.
    2. Prior chemotherapy or radiotherapy within 4 weeks (other than a short cycle of palliative radiotherapy for bone pain) of first receipt of study treatment.
    3. Patients unable to swallow oral medications or with preexisting GI disorders that might interfere with proper absorption of the oral drug.
    4. History of other malignancy, either primary or recurrent, within the past 2 years, except basal cell skin carcinoma or in situ cervical carcinoma.
    5. History of active seizure disorder (e.g. event ≤ 2 months prior to start of study).
    6. Patients with a history of CNS metastases or leptomeningeal metastases, except for those who have clinically stable disease characterized by all the following:
    • surgical resection and/or radiotherapy completed ≥ 2 months prior to first dosing.
    • no corticosteroid requirements for CNS disease for ≥ 4 weeks prior to first dosing.
    • stable disease measured by CT or MRI within 4 weeks of first dosing.
    • stable neurologic exam (no new global or focal abnormalities) for at least 4 weeks prior to first dosing.
    To confirm eligibility, a discussion between the Investigator and Sponsor is required for patients with CNS disease.
    7. Serious cardiovascular illness including but not confined to symptomatic CHF, unstable angina pectoris, symptomatic cardiac arrhythmia or cardiac pacemaker requirement.
    8. QTcF > 450 msec (males) and QTcF > 470 msec (females) at screening.
    9. Other uncontrollable, concurrent illness including, but not limited to: significant hypoxia requiring chronic oxygen therapy; active or uncontrolled infection, altered mental status or psychiatric illness that would limit compliance with study requirements.
    10. Pregnant women and women who are breast feeding.
    11. Unwillingness or inability to use acceptable (e.g. barrier) method of contraception during study and up to 4 weeks post last dose of study medication for non-sterile men and women of child-bearing potential and women less than 2 years after menopause.
    12. Patients receiving CYP3A4 substrates, or inhibitors within 7 days prior to receipt of study drug and CYP3A4 inducers within 14 days prior receipt of study drug.
    13. Major surgery within 28 days of first receipt of study drug.
    14. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that in the opinion of the Investigator, contraindicates the use of an investigational drug, or that may render the patient at excessively high risk for treatment complications.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the assessment of changes in tumor blood flow and tumor metabolic response rate following treatment with RO4929097 (see section 8.1 in the protocol).
    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 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Information not present in EudraCT
    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
    The study will be completed following the date at which the last data point, required for statistical analysis, from the last patient is received. However, patients who demonstrate signs of study treatment-related toxicity will be followed until such toxicities have resolved, or the patient has started another type of therapy.
    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 months4
    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 months4
    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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-07-20. Yes
    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 state32
    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 who demonstrate signs of study treatment-related toxicity will be followed until such toxicities have resolved, or the patient has started another type of therapy.
    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 Decision2009-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-08-16
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