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 Drug Response Prediction (DRP) after failure of an anthracycline and a taxane
- Conditions
- Recurrent or metastatic breast cancer10006291
- Registration Number
- NL-OMON53513
- Lead Sponsor
- Allarity Therapeutics Europe ApS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 5
1. Patients with histologically or cytological confirmed adenocarcinoma of the
breast and with confirmed locally recurrent or metastatic disease
2. Patients with hormone receptor positive and HER2 negative or triple negative
primary tumor.
3. Previous chemotherapies (neoadjuvant, adjuvant or in the metastatic setting)
must have included a taxane and an anthracycline unless anthracycline therapy
is not indicated.
4. Maximum of three (3) prior chemotherapies in the metastatic setting in
addition to any number of prior lines of endocrine therapy
5. Measurable disease by RECIST v 1.1 criteria
6. Performance status of ECOG <= 1
7. DRP-Ixempra-Breast - score of >33% in an archival biopsy or in a more
recent biopsy. If two biopsies are available and disagree the archival biopsy
takes precedence.
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 the following strong inhibitors
of CYP3A4:
Clarithromycin, ketoconazole, itraconazole, ritonavir, amprenavir, indinavir,
nelfinavir, delavirdine, saquinavir and voriconazole. These therapies should be
discontinued 72 hours prior to initiation of study drug therapy. Similarly,
patients must not continue treatment with the following strong inducers of
CYP3A4: 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Clinical Benefit Rate (CBR) will be defined as the proportion of patients<br /><br>having a Complete Response (CR), Partial Response (PR), or Stable Disease (SD)<br /><br>for at least 24 weeks</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Progression Free Survival (PFS) defined as time from first dose until<br /><br>progressive diseas e(PD) according to RECIST v 1.1 or death, whichever occurs<br /><br>first<br /><br>• Overall Survival (OS) defined as the time from first dose until death from<br /><br>any cause<br /><br>• Objective Response Rate (ORR) defined as the proportion of patients with<br /><br>complete response (CR) + partial response (PR) according to RECIST v 1.1<br /><br>• Duration of response (DOR) defined as time of first documented CR or PR<br /><br>response until documented tumor progression (RECIST v 1.1)<br /><br>• Frequency of change in DRP-Ixempra-Breast between archival and fresh biopsies<br /><br>• An elicited toxicity in target organs based on the Common Terminology<br /><br>Criteria for Adverse Events (NCI-CTCAE v.5.0)<br /><br>• A description of the frequency and severity of adverse events based on CTCAE<br /><br>v.5.0<br /><br>• Hematology and clinical biochemistry<br /><br>• Vital signs</p><br>