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Chemotherapy
SDX-7320 + Eribulin for Breast Cancer
Phase 2
Recruiting
Led By Neil Iyengar, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evidence of metabolic dysfunction defined as HbA1c > 5.5 and/or BMI ≥ 30 kg/m^2
Received prior anthracycline and taxane chemotherapy in the neoadjuvant, adjuvant, or metastatic settings and considered appropriate for treatment with single agent eribulin
Must not have
Child Pugh score of B or C
Established diagnosis of diabetes mellitus type I or uncontrolled or insulin-dependent type II
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
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.
Who is the study for?
This trial is for adults with triple-negative metastatic breast cancer who have metabolic dysfunction (HbA1c > 5.5 or BMI ≥ 30), previously treated with anthracycline and taxane, and suitable for eribulin therapy. Participants must not have had more than two prior therapies for advanced cancer, no severe heart issues, uncontrolled HIV, known allergies to the drugs tested, underweight conditions (BMI < 18.5), brain malignancies or active CNS pathology.
What is being tested?
The study tests SDX-7320 combined with standard chemotherapy drug eribulin against eribulin alone in treating breast cancer patients with metabolic dysfunction. The goal is to assess effectiveness and safety of this combination treatment compared to the standard therapy.
What are the potential side effects?
Potential side effects may include reactions related to SDX-7320 or eribulin such as fatigue, nausea, hair loss from chemotherapy, allergic reactions to medication components, potential blood disorders due to bone marrow suppression by chemotherapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My HbA1c is above 5.5 or my BMI is 30 or more.
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I've had anthracycline and taxane chemotherapy and can be treated with eribulin.
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I am fully active or can carry out light work.
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My blood tests show my organs and bone marrow are working well.
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I have triple-negative metastatic breast cancer that is not responsive to hormones or HER2 treatments.
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My cancer is advanced or has spread, and I've had up to 2 treatments for it.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My liver disease is moderately to severely advanced.
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I have type 1 diabetes or type 2 diabetes that requires insulin.
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I have had three or more treatments for advanced triple-negative breast cancer.
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I do not have any major heart problems or recent heart events.
Select...
I am allergic to SDX-7320 or eribulin.
Select...
My HIV infection is not under control.
Select...
I do not have a brain tumor or active brain issues.
Select...
I have had acute pancreatitis in the last year or have chronic pancreatitis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
change in insulin resistance scores (HOMA-IR)
Secondary study objectives
Overall response rate
Therapeutic procedure
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: SDX-7320 plus Eribulin (safety run-in period)Experimental Treatment2 Interventions
During the safety run-in period, the first 15 patients enrolled will be assigned to received study drug SDX-7320 plus Eribulin. Not randomized.
Group II: SDX-7320 plus EribulinExperimental Treatment2 Interventions
Patients randomized to SDX-7320 plus Eribulin.
Group III: Eribulin Plus PlaceboPlacebo Group2 Interventions
Patients randomized to the control arm will receive placebo plus Eribulin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eribulin
2012
Completed Phase 3
~2740
SDX-7320
2016
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
SynDevRx, Inc.Industry Sponsor
2 Previous Clinical Trials
84 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
600,023 Total Patients Enrolled
207 Trials studying Breast Cancer
82,908 Patients Enrolled for Breast Cancer
Neil Iyengar, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
389 Total Patients Enrolled
3 Trials studying Breast Cancer
260 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver disease is moderately to severely advanced.I am willing and able to follow the study's requirements, including fasting before treatment.I have type 1 diabetes or type 2 diabetes that requires insulin.My cancer can be measured by scans or I have a specific type of bone lesion.I am a sexually active male and agree to use condoms.I have had three or more treatments for advanced triple-negative breast cancer.I do not have any major heart problems or recent heart events.My HbA1c is above 5.5 or my BMI is 30 or more.I am allergic to SDX-7320 or eribulin.My HIV infection is not under control.Your body mass index is less than 18.5.I am taking medication that cannot be stopped a week before treatment begins.I've had anthracycline and taxane chemotherapy and can be treated with eribulin.I do not have a brain tumor or active brain issues.You have had serious skin reactions to medications in the past.I have had acute pancreatitis in the last year or have chronic pancreatitis.I am fully active or can carry out light work.My blood tests show my organs and bone marrow are working well.I haven't had cancer in the last 3 years, except for certain skin cancers or treated cervical cancer.I am over 18 and have given written consent for the study.I have triple-negative metastatic breast cancer that is not responsive to hormones or HER2 treatments.My cancer is advanced or has spread, and I've had up to 2 treatments for it.You have uncontrolled active Hepatitis B or C infection.
Research Study Groups:
This trial has the following groups:- Group 1: Eribulin Plus Placebo
- Group 2: SDX-7320 plus Eribulin
- Group 3: SDX-7320 plus Eribulin (safety run-in period)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.