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

NCT04796324 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: AL-2001
• Study Type: interventional
• Target: 13
• Locations: 7 countries
• Sites: 19

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Clinical Benefit Rate (CBR)

  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.

  Baseline to 24 weeks

Secondary Outcomes (5)

• Progression Free Survival (PFS)

  1 year

• Overall Survival (OS)

  1 year

• Overall Response Rate (ORR) Defined as CR + PR

  1 year

• Incidence of Treatment-Emergent Adverse Events Measured by NCI-CTCAE v.5.0

  1 year

• Clinical Benefit Rate (CBR) - Fresh Biopsy Versus Archival

  1 year

Study Arms (1)

Ixabepilone

EXPERIMENTAL

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

Drug: Ixabepilone Injection

Interventions

Ixabepilone Injection DRUG

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

Ixabepilone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form
• Age 18 years or older
• Patients with histologically or cytological confirmed carcinoma of the breast. Patients with locally recurrent or metastatic disease
• Patients with HR-positive, HER negative tumors or triple negative tumors
• Previous chemotherapies (neo, adjuvant or in the metastatic setting) must have included a taxane and an anthracycline unless anthracycline therapy is not indicated.
• Maximum of three (3) prior chemotherapies in the metastatic setting in addition to any number of prior lines of endocrine therapy
• Measurable disease
• Performance status of ECOG ≤ 1
• With an Ixabepilone DRP - score of \>33% (Germany \>67%)
• Adequate conditions as evidenced by the following clinical laboratory values:
• Absolute neutrophils count (ANC) ≥ 1.5 x 109/L
• Hemoglobin \> 6.2 mmol/L
• Platelets ≥ 100 x 109 /L
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN
• Serum bilirubin ≤ 1.0 ULN

You may not qualify if:

• HER2 positive tumor
• Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period
• Patients with intracranial disease
• Other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study
• Any active infection requiring parenteral or oral antibiotic treatment.
• Patients with grade 2, in case of diabetes grade 1 or greater neuropathy
• Clinically significant (i.e. active) cardiovascular disease:
• Stroke within ≤ 6 months prior to day 1
• Transient ischemic attach (TIA) within ≤ 6 months prior to day 1
• Myocardial infarction within ≤ 6 months prior to day 1
• Unstable angina
• New York Hart Association (NYHA) Class II or greater congestive heart failure (CHF)
• Serious cardiac arrhythmia requiring medication
• 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.
• Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy

Sponsors & Collaborators

• Allarity Therapeutics: lead

Study Sites (19)

Onze-Lieve-Vrouwziekenhuis

Aalst, Aalst, 9300, Belgium

Location

Antwerp University Hospital

Antwerp, Edegem, 2650, Belgium

Location

Clin. Univ. Saint-Luc

Brussels, 1200, Belgium

Location

CHU de Liege, Oncology Department

Liège, 4000, Belgium

Location

Tampere University Hospital

Tampere, Pirkanmaa, 33520, Finland

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Modena University Hospital

Modena, 41124, Italy

Location

Ikazia Hospital Rotterdam

Rotterdam, 3083, Netherlands

Location

Wojewodzki Szpital Specjalietyczny

Biała Podlaska, Biala Podlaska, 21-500, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

Location

Centrum Onkologii Ziemi Lubelskiej im.

Lublin, 20-090, Poland

Location

Oddział Onkologii Klinicznej, Szpital Kliniczny Przemienienia Pańskiego UM w Poznaniu

Poznan, 61-848, Poland

Location

Medway NHS Foundation Trust

Gillingham, Kent, ME7 5NY, United Kingdom

Location

Nottingham University Hospitals

Nottingham, Nottingham, NG5 1PB, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Somerset NHS Foundation Trust

Taunton, Somerset, TA1 5DA, United Kingdom

Location

Cancer Institute Singleton Hospital

Swansea, Wales, SA2 8QA, United Kingdom

Location

Edinburgh Cancer Centre, Western General Hospital

Edinburgh, EH4 2XR, United Kingdom

Location

St James Hospital

Leeds, LS9 7TF, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Jeremy Graff
• Organization: Allarity Therapeutics

jgraff@allarity.com

317-452-3833

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle.

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 12, 2021
• Study Start: March 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: November 1, 2025
• Last Updated: March 12, 2026
• Results First Posted: March 12, 2026

Record last verified: 2026-03

Locations

DE (1); BE (4); PL (4); NL (1); IT (1); FI (1); GB (7)