Trial Outcomes & Findings for Anti-tumor Effect of Ixabepilone in Metastatic Breast Cancer (mBC) Selected by the Ixabepilone DRP. (NCT NCT04796324)

Last Updated: 2026-03-12

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Baseline to 24 weeks

Results posted on

2026-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	Ixabepilone Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle Ixabepilone Injection: Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ixabepilone n=13 Participants Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle Ixabepilone Injection: Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle
Age, Categorical <=18 years	0 Participants n=13 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=13 Participants
Age, Categorical >=65 years	7 Participants n=13 Participants
Age, Continuous	59 years STANDARD_DEVIATION 8.7 • n=13 Participants
Sex: Female, Male Female	13 Participants n=13 Participants
Sex: Female, Male Male	0 Participants n=13 Participants
Region of Enrollment Netherlands	1 participants n=13 Participants
Region of Enrollment Belgium	6 participants n=13 Participants
Region of Enrollment Poland	3 participants n=13 Participants
Region of Enrollment United Kingdom	3 participants n=13 Participants

PRIMARY outcome

Timeframe: Baseline to 24 weeks

Outcome measures

Outcome measures
Measure	Ixabepilone n=13 Participants Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle Ixabepilone Injection: Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle
Clinical Benefit Rate (CBR)	2 participants with partial response

SECONDARY outcome

Timeframe: 1 year

PFS defined as time from inclusion until progressive disease(PD) according to RECIST v 1.0 or death of any reason

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

OS defined as time from inclusion until death

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Objective response rate (ORR) as defined as complete response (CR) + partial response (PR) according to RECIST v 1.0

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Assess difference in prediction based on archival and fresh biopsy from same patient (percent agreement in binary prediction, and difference in primary and secondary endpoints with archival versus fresh biopsies)

Outcome measures

Outcome data not reported

Adverse Events

Ixabepilone

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ixabepilone n=13 participants at risk Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle Ixabepilone Injection: Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle
Nervous system disorders Tremor	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Blood and lymphatic system disorders Anaemia	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Blood and lymphatic system disorders Neutropenia	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
General disorders General physical health deterioration	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
General disorders Asthenia	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.

Other adverse events

Other adverse events
Measure	Ixabepilone n=13 participants at risk Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle Ixabepilone Injection: Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle
General disorders Asthenia	15.4% 2/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
General disorders Fatigue	53.8% 7/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
General disorders General physical health deterioration	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
General disorders Mucosal inflammation	15.4% 2/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
General disorders Oedema peripheral	15.4% 2/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Immune system disorders Hypersensitivity	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Immune system disorders Cough	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Immune system disorders Dyspnoea	15.4% 2/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Immune system disorders Epistaxis	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Immune system disorders Hydrothorax	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Immune system disorders Hypoventilation	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Immune system disorders Hypoxia	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Immune system disorders Interstitial lung disease	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Immune system disorders Nasal congestion	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Immune system disorders Productive cough	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Immune system disorders Pulmonary embolism	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Immune system disorders Rhinorrhoea	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Immune system disorders Insomnia	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Immune system disorders Mood altered	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Investigations Platelet count decreased	15.4% 2/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Investigations Weight decreased	15.4% 2/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Cardiac disorders Sinus tachycardia	15.4% 2/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Nervous system disorders Balance disorder	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Nervous system disorders Dizziness	15.4% 2/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Nervous system disorders Dysgeusia	15.4% 2/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Nervous system disorders Headache	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Nervous system disorders Neuralgia	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Nervous system disorders Neuropathy peripheral	53.8% 7/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Nervous system disorders Polyneuropathy	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Nervous system disorders Tremor	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Blood and lymphatic system disorders Anaemia	23.1% 3/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Blood and lymphatic system disorders Leukopenia	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Blood and lymphatic system disorders Neutropenia	53.8% 7/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Blood and lymphatic system disorders Thrombocytopenia	23.1% 3/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Ear and labyrinth disorders Vertigo	15.4% 2/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Gastrointestinal disorders Abdominal pain	23.1% 3/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Gastrointestinal disorders Abdominal pain upper	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Gastrointestinal disorders Anal hypoaesthesia	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Gastrointestinal disorders Constipation	23.1% 3/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Gastrointestinal disorders Diarrhoea	38.5% 5/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Gastrointestinal disorders Dry mouth	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Gastrointestinal disorders Dyspepsia	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Gastrointestinal disorders Gastrointestinal pain	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Gastrointestinal disorders Gastrooesophageal reflux disease	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Gastrointestinal disorders Nausea	38.5% 5/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Gastrointestinal disorders Proctalgia	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Gastrointestinal disorders Stomatitis	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Gastrointestinal disorders Toothache	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Gastrointestinal disorders Vomiting	38.5% 5/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Hepatobiliary disorders Hepatic failure	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Hepatobiliary disorders Hepatic pain	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Skin and subcutaneous tissue disorders Alopecia	46.2% 6/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Skin and subcutaneous tissue disorders Dry skin	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Skin and subcutaneous tissue disorders Erythema	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Skin and subcutaneous tissue disorders Nail discolouration	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Skin and subcutaneous tissue disorders Plantar erythema	15.4% 2/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Skin and subcutaneous tissue disorders Pruritus	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Skin and subcutaneous tissue disorders Rash	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Endocrine disorders Cushingoid	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	15.4% 2/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Musculoskeletal and connective tissue disorders Back pain	15.4% 2/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Musculoskeletal and connective tissue disorders Flank pain	15.4% 2/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Musculoskeletal and connective tissue disorders Muscular weakness	30.8% 4/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Musculoskeletal and connective tissue disorders Myalgia	23.1% 3/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Musculoskeletal and connective tissue disorders Tendon pain	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Infections and infestations Cystitis	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Infections and infestations Oral candidiasis	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Infections and infestations Pneumonia	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Infections and infestations Sinusitis	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Infections and infestations Staphylococcal sepsis	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Infections and infestations Urinary tract infection	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Metabolism and nutrition disorders Diabetes mellitus	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Metabolism and nutrition disorders Decreased appetite	46.2% 6/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Metabolism and nutrition disorders Hypercalcaemia	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.
Metabolism and nutrition disorders Hyperkalaemia	7.7% 1/13 • Documentation of Adverse Events started as soon as the patient has signed the Informed Consent and continued until patient's final visit, up to 24 weeks.

Additional Information

Jeremy Graff

Allarity Therapeutics

Phone: 317-452-3833

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place