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Official Title

"A Phase 2, Double Blinded, Randomized Controlled Trial of Evexomostat (SDX-7320) or Placebo in Combination With Eribulin for Patients With Metastatic Triple-Negative Breast Cancer and Metabolic Dysfunction: The ARETHA Study

Phase
Phase 2
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
55
Timeline
Oct 2022 → Oct 2027
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Male 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+ at enrolling institution (note: if IHC is equivocal, non-amplified status by FISH is acceptable)
  • 2Advanced (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
  • 3Received 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.
  • 4Evidence of metabolic dysfunction defined as HbA1c \> 5.5 and/or BMI ≥ 30 kg/m\^2
  • 5Measurable disease per the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), OR at least one evaluable, predominantly lytic bone lesion
  • 6Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤1.
  • 7Adult ≥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.
  • 8Adequate bone marrow and organ function as defined by the following laboratory values (as assessed by local laboratory for eligibility):
  • 9Absolute neutrophil count (ANC) ≥ 1,000 µL
  • 10Platelet count ≥ 140,000 µL
  • 11Hemoglobin ≥9.0 g/dL:
  • 12Calcium (corrected for serum albumin) and magnesium ≤ Grade 1 according to National Cancer Institute (NCI) Common Terminology
  • 13Calculate Corrected Calcium if the albumin and/or serum calcium are not within normal limits: Corrected Calcium= Serum Calcium + 0.8 x \[(Normal Albumin) - Patient Albumin\] Normal Albumin value = 4.4g/dL Criteria for Adverse Events (CTCAE), version 5.0, and not considered by the Investigator to be clinically significant
  • 14Potassium within normal limits, with or without correction with supplements.
  • 15In 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.
  • 16Total 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
  • 17Creatinine ≤1.5 mg/dL.
  • 18Patient is, in the treating Investigator's opinion, willing and able to comply with the study requirements, including the ability to fast prior to treatment days.
  • 19If sexually active female of childbearing potential, willing to use a contraception method listed below:
  • 20Oral, intravaginal, or transdermal combined (estrogen and progesterone containing) hormonal contraception
  • 21Oral, injectable, or implantable progesterone-only hormonal contraception
  • 22Intrauterine device (IUD)
  • 23Intrauterine hormone-releasing system (IUS)
  • 24Bilateral tubal occlusion
  • 25Vasectomized partner with documentation of successful vasectomy.
  • 26Complete abstinence from heterosexual intercourse
  • 27If a sexually active male, willing to use barrier contraception (condoms)

Exclusion Criteria

  • 1Three or greater prior lines of therapy for metastatic TNBC
  • 2Known primary brain malignancy, brain metastases or active CNS pathology, any of which as determined by the treating Investigator
  • 3Currently participating in a study of an investigational agent
  • 4Body mass index \< 18.5 kg/m2
  • 5Known hypersensitivity to SDX-7320 or eribulin
  • 6Established 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%
  • 7Use of combination antihyperglycemic therapy (single agent metformin on stable dose for at least 3 months prior to enrollment is allowable)
  • 8Concurrent 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.
  • 9Uncontrolled human immunodeficiency virus (HIV) infection. (Testing is not mandatory.)
  • 10Evidence of uncontrolled active Hepatitis B or C infection
  • 11History of Stevens-Johnson Syndrome (SJS), erythema multiforme (EM), toxic epidermal necrolysis (TEN), or other severe medication-related cutaneous reactions.
  • 12Any 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).
  • 13Clinically significant, uncontrolled heart disease and/or recent cardiac events including any of the following:
  • 14History of angina pectoris, coronary artery bypass graft (CABG) symptomatic pericarditis, or myocardial infarction within 6 months prior to study entry.
  • 15History of documented congestive heart failure (New York Heart Association functional classification III-IV).
  • 16Documented cardiomyopathy.
  • 17Left ventricular ejection fraction (LVEF) \<45%, as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO).
  • 18History 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.
  • 19Uncontrolled 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
  • 20Long 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.
  • 21Bradycardia (heart rate less than 50 at rest), by electrocardiogram (ECG) or pulse.
  • 22Inability 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
  • 23Currently 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.
  • 24°Herbal preparations/medications, with the exception of cannabinoids, CBD compounds, etc.
  • 25Participation 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.
  • 26History of acute pancreatitis within 1 year of Screening or past medical history of chronic pancreatitis
  • 27Pregnant patients

Locations

10 sites participating in this study

Emory University (Data Collection Only)

Atlanta, Georgia 30322

Recruiting

Neil Iyengar, MD

404-778-1900

BAPTIST ALLIANCE - MCI (Data Collection Only)

Miami, Florida 33143

Recruiting

Lauren Carcas, MD

954-837-1490

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey 07920

Recruiting

Sherry Shen, MD

646-888-5134
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →