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

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ClinicalTrials.gov Identifier: NCT04796324
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Allarity Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Ixabepilone Injection Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle.
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Ixabepilone

Arm Intervention/treatment
Experimental: Ixabepilone
Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle
Drug: Ixabepilone Injection
Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle




Primary Outcome Measures :
  1. Clinical Benefit Rate (CBR) [ Time Frame: 1 year ]
    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 :
  1. Progression free survival (PFS) [ Time Frame: 1 year ]
    PFS defined as time from inclusion until progressive disease(PD) according to RECIST v 1.0 or death of any reason

  2. Overall survival (OS) [ Time Frame: 1 year ]
    OS defined as time from inclusion until death

  3. Overall response rate (ORR) defined as CR + PR [ Time Frame: 1 year ]
    Objective response rate (ORR) as defined as complete response (CR) + partial response (PR) according to RECIST v 1.0

  4. Incidence of Treatment-Emergent Adverse Events measured by NCI-CTCAE v.5.0 [ Time Frame: 1 year ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04796324


Contacts
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Contact: Guy Jerusalem, Prof. Dr. g.jerusalem@chuliege.be

Locations
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Belgium
CHU de Liege, Oncology Department Recruiting
Liege, Belgium, 4000
Contact: Guy Jerusalem, Prof. Dr.         
Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33520
Contact: Minna Tanner, MD    +358 3 3116 7640    Minna.Tanner@pshp.fi   
United Kingdom
Nottingham University Hospitals Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Sachin Trivedi, MD    1159691169    Sachin.trivedi@nuh.nhs.uk   
Sponsors and Collaborators
Allarity Therapeutics
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Responsible Party: Allarity Therapeutics
ClinicalTrials.gov Identifier: NCT04796324    
Other Study ID Numbers: AL-2001
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases