Clinical Trials /

Anti-tumor Effect of Ixabepilone in Metastatic Breast Cancer (mBC) Selected by the Ixabepilone DRP.

NCT04796324

Description:

The purpose is to investigate anti-tumor effect of ixabepilone in patients with locally recurrent or metastatic breast cancer (mBC) selected by the Ixabepilone DRP after failure of an anthracycline and taxanes.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Anti-tumor Effect of Ixabepilone in Metastatic Breast Cancer (mBC) Selected by the Ixabepilone DRP.
  • Official Title: 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 DRP After Failure of an Anthracycline and Taxanes.

Clinical Trial IDs

  • ORG STUDY ID: AL-2001
  • NCT ID: NCT04796324

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
Ixabepilone InjectionIxabepilone

Purpose

The purpose is to investigate anti-tumor effect of ixabepilone in patients with locally recurrent or metastatic breast cancer (mBC) selected by the Ixabepilone DRP after failure of an anthracycline and taxanes.

Detailed Description

      Patients will be screened with the Ixabepilone DRP. If the tumor tissue has a DRP( Dose
      Response Prediction) score of >67% the patient can be included in the clinical study.
      Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle.
    

Trial Arms

NameTypeDescriptionInterventions
IxabepiloneExperimentalIxabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle
  • Ixabepilone Injection

Eligibility Criteria

        Inclusion Criteria:

          1. Signed informed consent form

          2. Age 18 years or older

          3. Patients with histologically or cytological confirmed carcinoma of the breast.
             Patients with locally recurrent or metastatic disease

          4. Patients with HR-positive, HER negative tumors or triple negative tumors

          5. Previous chemotherapies (neo, adjuvant or in the metastatic setting) must have
             included a taxane and an anthracycline unless anthracycline therapy is not indicated.

          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

          8. Performance status of ECOG ≤ 1

          9. With an Ixabepilone DRP - score of >67%

         10. Adequate conditions as evidenced by the following clinical laboratory values:

               1. Absolute neutrophils count (ANC) ≥ 1.5 x 109/L

               2. Hemoglobin > 6.0 mmol/L

               3. Platelets ≥ 100 x 109 /L

               4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN

               5. Serum bilirubin ≤ 1.0 ULN

               6. Alkaline phosphatase ≤ 2.5 x ULN Creatinine ≤ 1.5 ULN

               7. Blood urea within normal limits

         11. Because of possible interference of cytochrome P450 3A4 activity by ixabepilone,
             patients were excluded from receiving the following medications at enrollment and
             while enrolled onto the study: amiodarone, clarithromycin, erythromycin, fluconazole,
             itraconazole, ketoconazole, indinavir, nelfinavir, ritonavir, and saquinavir

         12. Women of childbearing age and potential must be willing to use effective contraception
             during the study and at least until 90 days 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 90
             days 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 such as intrauterine devices or hormonal contraception
             (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting
             injections)

        Exclusion Criteria:

          1. Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug
             except non-disease related conditions (e.g. insulin for diabetes) during study period

          2. Patients with intracranial disease

          3. Other malignancy with exception of curative treated non-melanoma skin cancer or
             cervical carcinoma in situ within 5 years prior to entering the study

          4. Any active infection requiring parenteral or oral antibiotic treatment.

          5. Patients with grade 2, in case of diabetes grade 1 or greater neuropathy

          6. Clinically significant (i.e. active) cardiovascular disease:

          7. Stroke within ≤ 6 months prior to day 1

          8. Transient ischemic attach (TIA) within ≤ 6 months prior to day 1

          9. Myocardial infarction within ≤ 6 months prior to day 1

         10. Unstable angina

         11. New York Hart Association (NYHA) Class II or greater congestive heart failure (CHF)

         12. Serious cardiac arrhythmia requiring medication

         13. 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.

         14. Requiring immediate palliative treatment of any kind including surgery and/or
             radiotherapy

         15. Female patients who are pregnant or breast-feeding (pregnancy test with a positive
             result before study entry)

         16. Known prior severe hypersensitivity reactions to agents containing polyoxyethylated
             castor oil (Cremophor EL)

         17. Known hypersensitivity to fluoropyrimidines;

         18. Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency;

         19. Patients must not continue treatment with the following strong inhibitors of CYP3A4:

        ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine and
        voriconazole. These therapies should be discontinued 72 hours prior to initiation of study
        drug therapy.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Clinical Benefit Rate (CBR)
Time Frame:1 year
Safety Issue:
Description:To evaluate the clinical benefit rate of ixabepilone using tumor measurements (e.g. CT or MRI etc.). One-sided comparisons of CBR between treatment and historic control will be performed, and will be repeated for subgroups defined by ER status.

Secondary Outcome Measures

Measure:Progression free survival (PFS)
Time Frame:1 year
Safety Issue:
Description:PFS defined as time from inclusion until progressive disease(PD) according to RECIST v 1.0 or death of any reason
Measure:Overall survival (OS)
Time Frame:1 year
Safety Issue:
Description:OS defined as time from inclusion until death
Measure:Overall response rate (ORR) defined as CR + PR
Time Frame:1 year
Safety Issue:
Description:Objective response rate (ORR) as defined as complete response (CR) + partial response (PR) according to RECIST v 1.0
Measure:Incidence of Treatment-Emergent Adverse Events measured by NCI-CTCAE v.5.0
Time Frame:1 year
Safety Issue:
Description:A description of the extent, duration and reversibility of ixabepilone elicited toxicity in target organs based on the Common Terminology Criteria for Adverse Events (NCI-CTCAE v.5.0)

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Allarity Therapeutics

Last Updated

March 12, 2021