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    Summary
    EudraCT Number:2010-024237-23
    Sponsor's Protocol Code Number:CDI-CS-001
    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:2011-01-04
    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 number2010-024237-23
    A.3Full title of the trial
    An Open-Label Phase I/IIa Study of Intravenous BAL101553 in Adult Patients with Advanced Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BAL101553 in Patients with Advanced Solid Tumors
    A.4.1Sponsor's protocol code numberCDI-CS-001
    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 SponsorBasilea Pharmaceutica International 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 supportBasilea Pharmaceutica International Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBasilea Pharmaceutical International Ltd.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 487
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4005
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+416061400
    B.5.5Fax number+416061216
    B.5.6E-mailmedical.information@basilea.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 nameBAL101553
    D.3.2Product code BAL101553-002
    D.3.4Pharmaceutical form Powder 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 INNnot assigned yet
    D.3.9.1CAS number not assigned
    D.3.9.2Current sponsor codeBAL101553-002
    D.3.9.3Other descriptive nameCDI
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number151.9
    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 or recurrent solid tumors
    E.1.1.1Medical condition in easily understood language
    Advanced or recurrent solid tumors
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLT) of BAL101553 administered intravenously as single agent on days 1, 8 and 15 of an every 28 day treatment cycle in adults with advanced or recurrent solid tumors, who have failed standard therapy or for whom no effective standard therapy is available
    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    •To evaluate the safety and tolerability of BAL101553.
    •To evaluate BAL101553 and BAL27862 pharmacokinetics.
    •To assess the anti-tumor activity of BAL101553 in cancer patients.
    Exploratory objectives are to assess the use of biomarkers and functional imaging to characterize pharmacodynamic effects and to explore the potential utility of biomarkers in blood and/or tumor tissue for patient stratification; and to assess SNP analysis related to drug-metabolism of BAL101553/BAL27862.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 years or older
    2. Patients with one of the following advanced or recurrent solid tumor types, who failed standard therapy or for whom no effective standard therapy is available
    a. Colorectal cancer
    b.Gastric cancer or cancers of the gastro-oesophageal junction
    c.Non-small cell lung cancer
    d. Ovarian (or primary peritoneal) cancer
    e. Pancreatic cancer (including ampullary cancer)
    f. Triple-negative breast cancer
    3.Patients with known brain metastases must have stable disease for at least 3 months prior to starting study drug. For these patients imaging of the brain is required during the 14-day screening period; patients must have undergone definitive local therapy (resection and/or radiation).
    Measurable disease (according to RECIST criteria v1.1 or RANO criteria for high-grade glioma) or non-measurable prostate or ovarian cancer that can be followed by PSA or CA-125
    4. Life expectancy ≥ 12 weeks
    5. Acceptable organ and marrow function
    6. ECOG performance status ≤ 2
    7. Signed, written informed consent must be obtained and documented according to ICH-GCP
    8. Other protocol-defined inclusion criteria apply.

    E.4Principal exclusion criteria
    1. Patients who have received chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to starting study drug or who have not recovered to ≤ CTCAE v4 grade 1 from all side effects of prior therapies except for residual toxicities, such as alopecia, which do not pose an ongoing medical risk
    2. Symptomatic brain metastases (including leptomeningeal disease) indicative of active disease
    3. Peripheral neuropathy ≥ CTCAE v4 grade 2
    Known human immunodeficiency virus (HIV) infection
    4. Significant cardiac disease or abnormality
    5. Uncontrolled intercurrent illness that would unduly increase the risk of toxicity or limit compliance with study requirements in the opinion of the investigator; including but not limited to: ongoing or active symptomatic infection, uncontrolled diabetes mellitus, unstable or uncompensated cardiac, hepatic, renal, respiratory, or
    psychiatric illness
    6. Current treatment with warfarin potassium or other coumarin derivates.
    7. Women who are pregnant or breast-feeding. Men or women of reproductive potential who are not willing to apply effective birth control during the study and for at least 30 days after the last dose of study drug in both sexes
    8. Other protocol-defined exclusion criteria apply.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to determine the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLT) of BAL101553 administered intravenously as single agent on days 1, 8 and 15 of an every 28 day treatment cycle in adults with advanced or recurrent solid tumors, who have failed standard therapy or for whom no effective standard therapy is available.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The MTD is determined by DLT assessment. A DLT can occur on any dosing day or at any time thereafter.
    E.5.2Secondary end point(s)
    Safety and tolerability, pharmacokinetics, anti-tumor activity
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety and tolerability is assessed during the whole clinical trial.
    Pharmacokinetic is assessed at prespecified time points at day 1, day 8 and day 15 during cycle 1 and cylce 2.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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 No
    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
    Please see protocol section 3.3.6
    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 months0
    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 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.1.2.1Number of subjects for this age range: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    For patients not qualified or incapable of giving legal consent, written consent must be obtained from the legally acceptable representative.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    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 hospital 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 Decision2011-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-06
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