Trial Title:
A Study of SDX-7320 in Combination With Eribulin for People With Breast Cancer
NCT ID:
NCT05570253
Condition:
Breast Cancer
Metastatic Triple-Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Conditions: Keywords:
Evexomostat (SDX-7320)
Eribulin
22-074
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
This is a single-center, placebo-controlled phase 2 randomized control trial.
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Eribulin
Description:
Eribulin 1.4 mg/m2 IV on days 1 and 8 of an every 21 day cycle.
Arm group label:
Eribulin Plus Placebo
Arm group label:
SDX-7320 plus Eribulin
Arm group label:
SDX-7320 plus Eribulin (safety run-in period)
Intervention type:
Drug
Intervention name:
SDX-7320
Description:
SDX-7320 at the dose of 49 mg/m2 SC on a Q14D basis
Arm group label:
SDX-7320 plus Eribulin
Arm group label:
SDX-7320 plus Eribulin (safety run-in period)
Intervention type:
Other
Intervention name:
Placebo
Description:
Placebo
Arm group label:
Eribulin Plus Placebo
Summary:
The researchers are doing this study to find out whether the study drug, SDX-7320, when
combined with the standard chemotherapy eribulin, is an effective treatment for people
with TNBC and metabolic dysfunction. The researchers will also look at whether the study
treatment (SDX-7320 combined with eribulin) is safe and causes few or mild side effects
in participants. The researchers will compare this treatment approach to eribulin alone.
Detailed description:
The study includes a safety run-in period in which the first 15 patients enrolled will be
assigned to receive the study drug SDX-7320 in combination with eribulin. Upon safety
confirmation, randomization will commence for the subsequent 40 patients enrolled.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female with histologically and/or cytologically confirmed diagnosis of
triple-negative metastatic breast cancer defined as estrogen and progesterone
receptor staining ≤10%; and HER2-negative defined as IHC 0 to 1+ (note: if IHC is
equivocal, non-amplified status by FISH is acceptable)
- Advanced (local regionally recurrent, not amenable to curative therapy or surgery)
or metastatic stage with up to 2 prior lines of therapy in the advanced or
metastatic setting
- Received prior anthracycline and taxane chemotherapy in the neoadjuvant, adjuvant,
or metastatic settings and considered appropriate for treatment with single agent
eribulin OR was otherwise ineligible to receive anthracycline and/or taxane per
treating physician OR patients with de novo metastatic disease.
- Evidence of metabolic dysfunction defined as HbA1c > 5.5 and/or BMI ≥ 30 kg/m^2
- Measurable disease per the Response Evaluation Criteria in Solid Tumors, version 1.1
(RECIST 1.1), OR at least one evaluable, predominantly lytic bone lesion
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤1.
- Adult ≥18 at the time of informed consent and has provided written informed consent
before the performance of any study-related activities and according to local
guidelines.
- Adequate bone marrow and organ function as defined by the following laboratory
values (as assessed by central laboratory for eligibility):
- Absolute neutrophil count (ANC) ≥ 1,000 µL
- Platelet count ≥ 140,000 µL
- Hemoglobin ≥9.0 g/dL:
- Calcium (corrected for serum albumin) and magnesium ≤ Grade 1 according to
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
(CTCAE), version 5.0, and not considered by the Investigator to be clinically
significant
- Potassium within normal limits, with or without correction with supplements.
- In absence of liver metastases, alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) ≤2.5×the upper limit of normal (ULN). If the patient has
liver metastases, ALT and AST ≤5×ULN.
- Total bilirubin ≤1.5×ULN except for patient with Gilbert's syndrome who may
only be included if the total bilirubin is ≤3.0×ULN or direct bilirubin
≤1.5×ULN
- Creatinine ≤1.5 mg/dL.
- Patient is, in the Investigator's opinion, willing and able to comply with the study
requirements, including the ability to fast prior to treatment days.
- If sexually active female of childbearing potential, willing to use a contraception
method listed below:
- Oral, intravaginal, or transdermal combined (estrogen and progesterone
containing) hormonal contraception
- Oral, injectable, or implantable progesterone-only hormonal contraception
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Vasectomized partner with documentation of successful vasectomy.
- Complete abstinence from heterosexual intercourse
- If a sexually active male, willing to use barrier contraception (condoms)
Exclusion Criteria:
- Three or greater prior lines of therapy for metastatic TNBC
- Known primary brain malignancy, brain metastases or active CNS pathology, any of
which as determined by the Investigator
- Currently participating in a study of an investigational agent
- Body mass index < 18.5 kg/m2
- Known hypersensitivity to SDX-7320 or eribulin
- Established diagnosis of diabetes mellitus type I or uncontrolled or
insulin-dependent type II. Uncontrolled is defined as fasting blood glucose >140
mg/dL and/or HbA1c ≥8%
- Use of combination antihyperglycemic therapy (single agent metformin on stable dose
for at least 3 months prior to enrollment is allowable)
- Child Pugh score of B or C.
- Concurrent malignancy or malignancy within 3 years of randomization, with the
exception of adequately treated, basal or squamous cell carcinoma, nonmelanomatous
skin cancer or curatively resected cervical cancer.
- Uncontrolled human immunodeficiency virus (HIV) infection. (Testing is not
mandatory.)
- Evidence of uncontrolled active Hepatitis B or C infection
- History of Stevens-Johnson Syndrome (SJS), erythema multiforme (EM), toxic epidermal
necrolysis (TEN), or other severe medication-related cutaneous reactions.
- Any other concurrent severe and/or uncontrolled medical condition that would, in the
Investigator's judgment, contraindicate patient participation in the clinical study
(e.g., chronic active hepatitis, severe hepatic impairment).
- Clinically significant, uncontrolled heart disease and/or recent cardiac events
including any of the following:
- History of angina pectoris, coronary artery bypass graft (CABG) symptomatic
pericarditis, or myocardial infarction within 6 months prior to study entry.
- History of documented congestive heart failure (New York Heart Association
functional classification III-IV).
- Documented cardiomyopathy.
- Left ventricular ejection fraction (LVEF) <45%, as determined by Multiple Gated
acquisition (MUGA) scan or echocardiogram (ECHO).
- History of any cardiac arrhythmias, (e.g., ventricular tachycardia), complete
left bundle block, high grade atrioventricular (AV) block (e.g., bifascicular
block, Mobitz type II and third-degree AV block) supraventricular, nodal
arrhythmias, or conduction abnormality in the previous 12 months.
- Uncontrolled hypertension, defined by a systolic blood pressure (SBP) ≥160 mmHg
and/or diastolic blood pressure (DBP) ≥100 mmHg, with or without
antihypertensive medication. Initiation or adjustment of antihypertensive
medication(s) is allowed prior to screening
- Long QT syndrome, family history of idiopathic sudden death or congenital long
QT syndrome or any of the following: risk factors for torsades de pointe
including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure
or history of clinically significant/symptomatic bradycardia; concomitant
medications with a known risk to prolong the QT interval and known to cause
torsades de pointe that cannot be discontinued or replaced by safe alternative
medications.
- Bradycardia (heart rate less than 50 at rest), by electrocardiogram (ECG) or
pulse.
- Inability to determine the QT interval on the ECG (i.e., unreadable or not
interpretable) or corrected QT (QTcF) >450 msec for males and >470 msec for
females (using Fridericia's correction) during Screening, based on the mean of
triplicate ECGs
- Currently receiving any of the following medications and cannot be discontinued 7
days prior to the start of the treatment: Medications with a known risk to prolong
the QT interval or induce Torsade de Pointes (TdP). CredibleMeds list of drugs known
to cause TdP may be used as a reference for this study to determine which drugs are
prohibited using the following link: https://crediblemeds.org/new-drug-list or a
crediblemeds mobile application.
°Herbal preparations/medications, with the exception of cannabinoids, CBD compounds,
etc.
- Participation in a prior investigational study within 14 days prior to the start of
the study treatment or within 5 half-lives of study drug, whichever is longer.
- History of acute pancreatitis within 1 year of Screening or past medical history of
chronic pancreatitis
- Pregnant patients
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
BAPTIST ALLIANCE - MCI (Data Collection Only)
Address:
City:
Miami
Zip:
33143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Carcas, MD
Phone:
954-837-1490
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neil Iyengar, MD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neil Iyengar, MD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Bergen (All Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neil Iyengar, MD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neil Iyengar, MD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Westchester (All Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neil Iyengar, MD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neil Iyengar, MD
Phone:
646-888-8103
Contact backup:
Last name:
Tiffany Traina, MD
Phone:
646-888-4558
Facility:
Name:
Memorial Sloan Kettering Nassau (All Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neil Iyengar, MD
Phone:
646-888-8103
Start date:
October 3, 2022
Completion date:
October 2027
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
SynDevRx, Inc.
Agency class:
Industry
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05570253
http://www.mskcc.org/mskcc/html/44.cfm
