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    Summary
    EudraCT Number:2009-014772-22
    Sponsor's Protocol Code Number:version 20-07-2009
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-04-28
    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 number2009-014772-22
    A.3Full title of the trial
    Chloroquine as an anti-autophagy drug in small cell lung cancer (SCLC) patients: A phase I trial to be followed by a phase II trial.
    A.3.2Name or abbreviated title of the trial where available
    chloroquine in SCLC
    A.4.1Sponsor's protocol code numberversion 20-07-2009
    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 SponsorMAASTRO Clinic
    B.1.3.4CountryNetherlands
    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 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 Yes
    D.2.1.1.1Trade name A-CQ 100
    D.2.1.1.2Name of the Marketing Authorisation holderARTECEF BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameChloroquine
    D.3.2Product code A-CQ 100
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral 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) 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
    To determine the toxicity of adding chloroquine in escalating doses in SCLC patients

    - to standard dose cisplatin-etoposide in extensive disease SCLC = STEP 1
    - to standard dose concurrent radiotherapy and cisplatin-etoposide in limited disease SCLC = STEP2
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level PT
    E.1.2Classification code 10041068
    E.1.2Term Small cell lung cancer extensive stage
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level PT
    E.1.2Classification code 10041069
    E.1.2Term Small cell lung cancer limited stage
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    fase I, step 1:To determine the toxicity of adding chloroquine in escalating doses in SCLC patients to standard dose cisplatin-etoposide in extensive disease SCLC

    fase I, step 2:To determine the toxicity of adding chloroquine in escalating doses in SCLC patients to standard dose concurrent radiotherapy and cisplatin-etoposide in limited disease SCLC

    fase II, step 1:To prove the efficacy of adding chloroquine to standard chemotherapy in a RPTD of … mg/day in extensive disease small cell lung cancer patients.
    fase II, step2:To prove the efficacy of adding chloroquine to standard chemotherapy and radiotherapy in a RPTD of … mg/day in limited disease small cell lung cancer patients.
    E.2.2Secondary objectives of the trial
    fase I, step 1 and fase I, step 2:
    - Tumor response (according to RECIST)
    - Overall survival

    fase II, step 1:
    1. Complete and overall tumor response rates (according to RECIST) as judged on a CT Thorax at 2-3 weeks after the last day of administration of chemotherapy
    2. Recording of the evolution of circulating biomarkers of hypoxia during therapy (hypothesis generating)
    3. Toxicity (CTC AE 4.0)
    4. Overall survival recorded at 1 year after the first day of chloroquine


    fase II, step 2:
    1. Complete and overall tumor response rates (according to RECIST) as judged on a CT Thorax at 2-3 weeks after the last day of administration of chemotherapy
    2. Recording of the evolution of circulating biomarkers of hypoxia during therapy (hypothesis generating)
    3. Toxicity (CTC AE 4.0)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Fase I, Step 1: chloroquine added to standard dose cisplatin-etoposide in extensive disease SCLC.

    1. Histologically or cytologically confirmed ``extensive disease`` (Stage T0-4 N0-3 M1) small cell lung cancer
    2. At least one measurable disease site, defined as lesion of ≥ 1 cm unidimensionally on CT-scan.
    3. WHO performance status 0-2
    4. Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and hemoglobin at least 6.2 mmol/l.
    5. Calculated creatinine clearance at least 60 ml/min
    6. Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution (in case of liver metastases ≤ 5 x ULN for the institution)
    7. No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.
    8. Life expectancy more than 6 months
    9. Willing and able to comply with the study prescriptions
    10. 18 years or older
    11. Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
    12. Ability to give and having given written informed consent before patient registration
    13. No mixed pathology, e.g. non-small cell plus small cell cancer

    Fase I, Step 2: chloroquine added to standard dose cisplatin-etoposide plus radiotherapy in limited disease SCLC.
    1. Histologically or cytologically confirmed `limited disease` ie stage T0-4 N0-3 M0 small cell lung cancer, excluding malignant pleural/pericardial effusion.
    2. At least one measurable disease site, defined as lesion of ≥ 1 cm unidimensionally on CT-scan.
    3. WHO performance status 0-2
    4. Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and hemoglobin at least 6.2 mmol/l.
    5. Calculated creatinine clearance at least 60 ml/min
    6. Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution (in case of liver metastases ≤ 5 x ULN for the institution)
    7. No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.
    8. Life expectancy more than 6 months
    9. Willing and able to comply with the study prescriptions
    10. 18 years or older
    11. Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
    12. Ability to give and having given written informed consent before patient registration
    13. No mixed pathology, e.g. non-small cell plus small cell cancer

    Fase II, step 1:
    1. Histologically or cytologically confirmed ``extensive disease`` (Stage T0-4 N0-3 M1) small cell lung cancer
    2. At least one measurable disease site, defined as lesion of ≥ 1 cm unidimensionally on CT-scan
    3. WHO performance status 0-2
    4. Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and hemoglobin at least 6.2 mmol/l.
    5. Calculated creatinine clearance at least 60 ml/min
    6. Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution (in case of liver metastases ≤ 5 x ULN for the institution)
    7. No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.
    8. Life expectancy more than 6 months
    9. Willing and able to comply with the study prescriptions
    10. 18 years or older
    11. Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
    12. Ability to give and having given written informed consent before patient registration
    13. No mixed pathology, e.g. non-small cell plus small cell cancer

    Fase II, step 2:
    1. Histologically or cytologically confirmed ``limited disease`` ie stage T0-4 N0-3 M0 small cell lung cancer, excluding malignant pleural/pericardial effusion.
    2. At least one measurable disease site, defined as lesion of ≥ 1 cm unidimensionally on CT-scan
    3. WHO performance status 0-2
    4. Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and hemoglobin at least 6.2 mmol/l.
    5. Calculated creatinine clearance at least 60 ml/min
    6. Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution (in case of liver metastases ≤ 5 x ULN for the institution)
    7. No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.
    8. Life expectancy more than 6 months
    9. Willing and able to comply with the study prescriptions
    10. 18 years or older
    11. Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
    12. Ability to give and having given written informed consent before patient registration
    13. No mixed pathology, e.g. non-small cell plus small cell cancer
    E.4Principal exclusion criteria
    the opposite of the above
    E.5 End points
    E.5.1Primary end point(s)
    Fase I, step 1 and 2: Toxicity (CTCAE 4.0)
    Fase II, step 1 : progression free survival
    Fase II, step 2: overall survival at 2 years
    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) Yes
    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 concerned3
    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 last visit of the last subject of the trial. Also mentioned in the protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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 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 state225
    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)
    As mentioned in the protocol
    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 Decision2010-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-30
    P. End of Trial
    P.End of Trial StatusOngoing
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