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

Phase 1

• Conditions: ocally recurrent or metastatic breast cancer; MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-004610-35-FI
• Lead Sponsor: Allarity Therapeutics Europe Aps

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-22
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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. DRP-Ixempra-Breast score of >33% in archival biopsy or in a more recent biopsy. If two biopsies are available and disagree, the archival biopsy takes precedence.
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.Because of possible interference of cytochrome P450 3A4 activity by ixabepilone, patients will be 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.Negative pregnancy test at baseline
13.Women of childbearing age and potential must be willing to use highly 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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.:
ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified