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    Summary
    EudraCT Number:2020-004610-35
    Sponsor's Protocol Code Number:AL-2001
    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:2023-05-22
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-004610-35
    A.3Full title of the trial
    Phase II, open label, single arm study to investigate anti-tumor effect of ixabepilone in patients with locally recurrent or metastatic breast cancer (mBC) selected by the ixabepilone Drug Response Prediction (DRP) after failure of an anthracycline and a taxane
    Fase II-, openlabelstudie met één onderzoekarm (één groep) om het antitumoreffect van ixabepilone onderzoeken bij patiënten met lokaal gerecidiveerde of gemetastaseerde borstkanker (mBC) die zijn geselecteerd door de ixabepilone-Drug Response Prediction (DRP) na het falen van een antracycline en een taxaan
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II, open label, single arm study to investigate anti-tumor effect of ixabepilone in patients with locally recurrent metastatic breast cancer (mBC) selected by the ixabepilone Drug Response Prediction (DRP) after failure of an anthracycline and a taxane
    A.4.1Sponsor's protocol code numberAL-2001
    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 SponsorAllarity Therapeutics Europe ApS
    B.1.3.4CountryDenmark
    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 supportAllarity Therapeutics
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllarity Therapeutics
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street AddressVenlighedvej 1
    B.5.3.2Town/ cityHørsholm
    B.5.3.3Post code2970
    B.5.3.4CountryDenmark
    B.5.4Telephone number14014264664
    B.5.6E-mailinfo@allarity.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 Yes
    D.2.1.1.1Trade name Ixempra
    D.2.1.1.2Name of the Marketing Authorisation holderR-Pharm US LLC, Princeton, NJ 08543, USA
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameIxabepilone
    D.3.4Pharmaceutical form Concentrate 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 INNazaepothilone B
    D.3.9.1CAS number 219989-84-1
    D.3.9.3Other descriptive nameIXABEPILONE
    D.3.9.4EV Substance CodeSUB33513
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    Locally recurrent or metastatic breast cancer
    E.1.1.1Medical condition in easily understood language
    Locally recurrent or metastatic breast cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    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
    To evaluate the clinical benefit rate (CBR) of ixabepilone
    E.2.2Secondary objectives of the trial
    • To evaluated progression free survival (PFS)
    • To evaluate overall survival (OS)
    • To evaluate objective response rate (ORR) defined as Complete Response (CR) and Partial Response (PR)
    • To evaluate the safety profile of ixabepilone in patient with locally recurrent or metastatic breast cancer
    • To further establish the clinical validation of the use of the DRP-Ixabepilone-Breast in selecting patients with locally recurrent or metastatic breast cancer
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent form
    2. Age 18 years or older
    3. Patients with histologically or cytological confirmed adenocarcinoma of the breast and with confirmed locally recurrent or metastatic disease
    4. Patients with hormone receptor positive and HER2 negative or triple negative primary tumor.
    5. Previous chemotherapies (neoadjuvant, adjuvant or in the metastatic setting) must have included a taxane and an anthracycline unless anthracycline therapy is not indicated or not in use.
    6. Maximum of three (3) prior chemotherapies in the metastatic setting in addition to any number of prior lines of endocrine therapy
    7. Measurable disease by RECIST v 1.1 criteria
    8. Performance status of ECOG ≤ 1
    9. Ixabepilone DRP - score of >33%
    10. Adequate conditions as evidenced by the following clinical laboratory values:
    a. Absolute neutrophils count (ANC) ≥ 1.5 x 109/L
    b. Hemoglobin > 10 g/dL (6.2 mmol/L)
    c. Platelets ≥ 100 x 109 /L
    d. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN
    e. Serum bilirubin ≤ 1.0 ULN
    f. Creatinine ≤ 1.5 ULN
    g. Alkaline phosphatase ≤ 2.5 x ULN or ≤5x ULN if documented liver/bone metastases.
    h. Blood urea within normal limits
    11. Negative pregnancy test at baseline
    12. Women of childbearing age and potential must be willing to use effective contraception during the study and at least until 7 months after last dose of study drug. Male patients or male patients who have female partners of childbearing age and potential must be willing to use effective contraception during the study and at least until 4 months after last dose of study drug. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly.
    E.4Principal exclusion criteria
    1. HER2 positive tumor
    2. Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period
    3. Patients with intracranial disease
    4. Other malignancies with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study
    5. Any active infection requiring parenteral or oral antibiotic treatment.
    6. Patients with grade 2, in case of diabetes grade 1 or greater neuropathy
    7. Clinically significant (i.e. active) cardiovascular disease:
    a. Stroke within ≤ 6 months prior to day 1
    b. Transient ischemic attach (TIA) within ≤ 6 months prior to day 1
    c. Myocardial infarction within ≤ 6 months prior to day 1
    d. Unstable angina
    e. New York Hart Association (NYHA) Class II or greater congestive heart failure (CHF)
    f. Serious cardiac arrhythmia requiring medication
    8. Other medications or conditions, including surgery, that in the Investigator’s opinion would contraindicate study participation for safety reasons or interfere with the interpretation of study results
    9. Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy
    10. Female patients who are pregnant or breast-feeding (pregnancy test with a positive result before study entry)
    11. Known prior severe hypersensitivity reactions to agents containing polyoxyethylated castor oil (Cremophor EL)
    12. Patients must not continue treatment with strong inhibitors of CYP3A4 e.g.:
    Clarithromycin, ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine, saquinavir and voriconazole. These therapies should be discontinued 72 hours prior to initiation of study drug therapy. Similarly, patients must not continue treatment with strong inducers of CYP3A4 e.g.: phenytoin, carbamazepine, rifampin, rifabutin, dexamethasone, and phenobarbital. (20 mg dexamethasone can be used for pre-treatment if required). These therapies should be discontinued 72 hours prior to initiation of study drug therapy
    13. Positive HIV and hepatitis B and C status, assessed from medical records only
    E.5 End points
    E.5.1Primary end point(s)
    Clinical Benefit Rate (CBR) will be defined as the proportion of patients having a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for at least 24 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    First tumor assessment is done at 6 weeks after start of IMP, then every 9 weeks.
    E.5.2Secondary end point(s)
    - PFS defined as time from randomisation until progressive disease(PD) according to RECIST v 1.1 or death, whichever occurs first
    - OS defined as the time from randomization until death from any cause
    - ORR defined as the proportion of patients with complete response (CR) + partial response (PR) according to RECIST v 1.1
    - Duration of response (DOR) defined as time of first documented CR or PR response until documented tumor progression (RECIST v 1.1)
    E.5.2.1Timepoint(s) of evaluation of this end point
    First tumour assessment is done at 6 weeks after start of IMP, then every 9 weeks. Patients who have received at least 2 cycles of treatment will be included in the per. protocol analyses.
    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 No
    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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Last visit of last patient
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 60
    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)
    Patient's can be enrolled in a compassionate use programme if their treating physician believes ixabepilone is the best treatment option for them at that time.
    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 Decision2023-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-05-22
    P. End of Trial
    P.End of Trial StatusOngoing
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