SDX-7320 plus Eribulin (safety run-in period) for Metastatic Triple-Negative Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Metastatic Triple-Negative Breast Cancer+1 MoreSDX-7320 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether adding SDX-7320 to standard chemotherapy eribulin helps people with TNBC and metabolic dysfunction, and whether it is safe.

Eligible Conditions
  • Metastatic Triple-Negative Breast Cancer
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 2 years

1 year
Overall response rate
change in insulin resistance scores (HOMA-IR)
2 years
Therapeutic procedure

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

SDX-7320 plus Eribulin (safety run-in period)
1 of 3
SDX-7320 plus Eribulin
1 of 3
Eribulin Plus Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

55 Total Participants · 3 Treatment Groups

Primary Treatment: SDX-7320 plus Eribulin (safety run-in period) · Has Placebo Group · Phase 2

SDX-7320 plus Eribulin (safety run-in period)Experimental Group · 2 Interventions: SDX-7320, Eribulin · Intervention Types: Drug, Drug
SDX-7320 plus EribulinExperimental Group · 2 Interventions: SDX-7320, Eribulin · Intervention Types: Drug, Drug
Eribulin Plus PlaceboPlaceboComparator Group · 2 Interventions: Eribulin, Placebo · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SDX-7320
2016
Completed Phase 1
~40
Eribulin
2012
Completed Phase 3
~3270

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

SynDevRx, Inc.Industry Sponsor
2 Previous Clinical Trials
84 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,362 Total Patients Enrolled
Neil Iyengar, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
498 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are female with histologically and/or cytologically confirmed triple-negative metastatic breast cancer.
You have metastatic disease or advanced disease with up to 2 prior lines of therapy in the advanced or metastatic setting.
You have a performance status of 1.