This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, Locally Recurrent or Metastatic Breast Cancer.
Active, not recruiting
Phase 3
| Drug | Synonyms | Arms |
|---|---|---|
| Eribulin | Eribulin Injection [Halaven] | Balixafortide + eribulin |
| Balixafortide | POL6326 | Balixafortide + eribulin |
| Name | Type | Description | Interventions |
|---|---|---|---|
| Eribulin | Active Comparator |
| |
| Balixafortide + eribulin | Experimental |
|
Key Inclusion Criteria:
- Histologically confirmed Breast cancer
- Metastatic Breast Cancer currently of stage IV disease or unresectable locoregionally
recurrent breast cancer
- refractory to the most recent chemotherapy, documented by progression on or within six
(6) months of therapy
- At least 14 days from the completion of any previous cancer therapy
- Adequate organ function
- Life expectancy of 3 months or more
- Willing and able to comply with the protocol and able to understand and willing to
sign an informed consent
Key Exclusion Criteria:
- Previously treated with eribulin
- Peripheral neuropathy Grade ≥3
- Receipt of prior CXCR4 therapy
- Receipt of colony stimulating factors (CSFs) filgrastim, pegfilgrastim, or
sargramostim, or radiation therapy within 14 days prior to study Day 1
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to balixafortide or eribulin or other agents used in the study
- Breast feeding or pregnant
- Patients with congestive heart failure, electrolyte abnormalities, bradyarrhythmias,
known congenital long QT syndrome, QT interval corrected with Fridericia's formula
(QTcF) ≥470 msec at baseline in the absence of bundle branch block, or currently
taking drugs at known risk of prolonging the QT interval or causing torsades de
pointes
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Progression Free Survival as assessed by Independent Review Committee |
| Time Frame: | 12 months after last patient randomized |
| Safety Issue: | |
| Description: |
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Polyphor Ltd. |
November 30, 2020
