SDX-7320 + Eribulin for Breast Cancer
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Must not be taking: Antihyperglycemics, QT-prolonging drugs
Disqualifiers: Diabetes, CNS pathology, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop all current medications. However, you cannot take medications that prolong the QT interval or induce Torsade de Pointes, and you must stop these 7 days before starting the trial. Herbal preparations are also not allowed, except for cannabinoids and CBD compounds.
What data supports the idea that SDX-7320 + Eribulin for Breast Cancer is an effective drug?
The available research shows that Eribulin, when used for breast cancer, has been associated with increased survival in patients who have already tried other treatments. In a key study, patients taking Eribulin lived about 13.2 months on average, compared to 10.6 months for those who did not take it. This suggests that Eribulin can help patients live longer. However, there is no specific data provided about the combination of SDX-7320 and Eribulin, so we can't say for sure how effective the combination is based on the information available.
12345What safety data is available for the treatment with SDX-7320 and Eribulin for breast cancer?
Eribulin, marketed as Halaven, has been approved for use in patients with locally advanced or metastatic breast cancer who have undergone at least two prior chemotherapy regimens. The European Medicines Agency and the U.S. FDA have reviewed its safety and efficacy. Common side effects include asthenia or fatigue and neutropenia. Eribulin has been studied in various clinical trials, including phase II and III trials, showing increased overall survival in patients. However, specific safety data for the combination of SDX-7320 and Eribulin is not detailed in the provided research.
26789Is the drug Eribulin a promising treatment for breast cancer?
Yes, Eribulin is a promising drug for breast cancer. It has been shown to increase overall survival in patients with advanced breast cancer who have already tried other treatments. It works by stopping cancer cells from dividing, which can lead to their death. This makes it a valuable option for patients with metastatic breast cancer.
127810Eligibility Criteria
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.Inclusion Criteria
I am willing and able to follow the study's requirements, including fasting before treatment.
My cancer can be measured by scans or I have a specific type of bone lesion.
If sexually active female of childbearing potential, willing to use a contraception method listed
+8 more
Exclusion Criteria
My liver disease is moderately to severely advanced.
Any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, contraindicate patient participation in the clinical study
I have type 1 diabetes or type 2 diabetes that requires insulin.
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Safety Run-in
The first 15 patients enrolled will receive SDX-7320 in combination with eribulin to confirm safety
4-6 weeks
Treatment
Participants receive either SDX-7320 plus eribulin or placebo plus eribulin
1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 year
Participant Groups
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.
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.
Eribulin is already approved in European Union, United States, Japan, Canada for the following indications:
🇪🇺 Approved in European Union as Halaven for:
- Locally advanced or metastatic breast cancer
🇺🇸 Approved in United States as Halaven for:
- Metastatic breast cancer
- Liposarcoma
🇯🇵 Approved in Japan as Halaven for:
- Breast cancer
- Soft tissue sarcoma
🇨🇦 Approved in Canada as Halaven for:
- Metastatic breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memorial Sloan Kettering Nassau (All Protocol Activities)Uniondale, NY
Memorial Sloan Kettering Monmouth (All Protocol Activities)Middletown, NJ
Memorial Sloan Kettering Bergen (All Protocol Activities)Montvale, NJ
BAPTIST ALLIANCE - MCI (Data Collection Only)Miami, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
SynDevRx, Inc.Industry Sponsor
References
A retrospective safety and efficacy analysis of the first patients treated with eribulin for metastatic breast cancer in Stockholm, Sweden. [2022]Eribulin is a non-taxane, microtubule dynamics inhibitor approved for the treatment of patients with metastatic breast cancer (MBC) in Europe in March 2011.
The European medicines agency review of eribulin for the treatment of patients with locally advanced or metastatic breast cancer: summary of the scientific assessment of the committee for medicinal products for human use. [2016]The European Commission issued on March 17, 2011, a marketing authorization valid throughout the European Union (EU) for eribulin (Halaven; Eisai Limited). The decision was based on the favorable opinion of the Committee for Medicinal Products for Human Use recommending a marketing authorization for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least 2 chemotherapeutic regimens for advanced disease. Eribulin mesylate is a structurally simplified synthetic analogue of halichondrin B, which is a natural product isolated from the marine sponge Halichondria okadai (ATC code L01XX41). Eribulin is a nontaxane, microtubule dynamics inhibitor belonging to the halichondrin class of antineoplastic agents. Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates leading to G(2)-M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage. The recommended dose of eribulin is 1.23 mg/m(2) (equivalent to 1.4 mg/m(2) eribulin mesylate) to be administered intravenously over 2 to 5 min on days 1 and 8 of a 3-week cycle. In the pivotal trial, eribulin was associated with increased overall survival in patients with locally advanced or metastatic breast cancer who received at least 2 prior chemotherapy lines for advanced disease (median overall survival was 13.2 months in the eribulin arm vs. 10.6 months in the control arm; HR = 0.805; 95% confidence interval, 0.677-0.958; P = 0.014). The most common side effects are asthenia or fatigue and neutropenia. The objective of this article is to summarize the scientific review of the application leading to approval in the EU. The detailed scientific assessment report and product information, including the summary report and product information, including product characteristics, are available on the European Medicines Agency website.
Perspectives on the mechanism of action and clinical application of eribulin for metastatic breast cancer. [2019]Eribulin is a novel microtubule inhibitor with mitotic and nonmitotic mechanisms of action. Both pooled and subgroup analyses from large-scale Phase III clinical trials demonstrated that eribulin has substantial activity in patients with pretreated (anthracycline and a taxane) advanced or metastatic breast cancer. We review recent pharmacological and clinical findings pertaining to eribulin use in metastatic breast cancer - particularly highlighting eribulin in difficult-to-treat and aggressive disease, and safety data in specific patient populations. Additionally, recent advancements in our understanding of the mechanism of action of eribulin and potential future directions for its clinical development are discussed. Ongoing studies of eribulin in combination with immunotherapies and established cytotoxic agents may help shape the future landscape of breast cancer treatment.
Eribulin mesylate: a novel halichondrin B analogue for the treatment of metastatic breast cancer. [2022]The pharmacology, pharmacokinetics, clinical efficacy, safety, and administration of eribulin in patients with metastatic breast cancer are reviewed.
A phase I dose-escalation study of eribulin and S-1 for metastatic breast cancer. [2018]We evaluated the safety, maximum-tolerated dose (MTD), pharmacokinetics, recommended dose for phase II (P2RD), and preliminary anticancer activity of a combination eribulin and S-1 therapeutic in metastatic breast cancer patients pretreated with anthracycline and taxane.
Network meta-analysis of eribulin versus other chemotherapies used as second- or later-line treatment in locally advanced or metastatic breast cancer. [2021]Eribulin mesylate (ERI; Halaven®) is a microtubule inhibitor approved in the United States for metastatic breast cancer patients with at least two prior chemotherapy regimens for metastatic breast cancer, and in the European Union in locally advanced breast cancer or metastatic breast cancer patients who progressed after at least one chemotherapy for advanced disease. This network meta-analysis compared the efficacy and safety of ERI versus other chemotherapies in this setting.
Eribulin, a simplified ketone analog of the tubulin inhibitor halichondrin B, for the potential treatment of cancer. [2019]Eisai Co Ltd is developing eribulin, a simplified synthetic macrocyclic ketone analog of the tubulin inhibitor halichondrin B, for the potential treatment of cancer. Phase III trials are underway in the US and Europe for patients with breast cancer. Eribulin is currently in phase II trials for NSCLC and soft tissue sarcoma, and pancreatic, prostate, ovarian, fallopian tube, peritoneal and head and neck cancer, and phase I/II trials for urothelial cancers.
Phase II study of eribulin mesylate, a halichondrin B analog, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. [2022]Eribulin mesylate (E7389), a nontaxane microtubule dynamics inhibitor, is a structurally simplified, synthetic analog of the marine natural product halichondrin B. This open-label, single-arm, phase II study evaluated efficacy and tolerability of eribulin in heavily pretreated patients with metastatic breast cancer (MBC).
Broad spectrum preclinical antitumor activity of eribulin (Halaven(R)): optimal effectiveness under intermittent dosing conditions. [2016]Eribulin is a pharmaceutically and structurally optimized analog of the marine sponge natural product halichondrin B. Its salt form, eribulin mesylate (Halaven®) is clinically used in the United States, the European Union, and Japan for the treatment of heavily pretreated patients with metastatic breast cancer, who previously received an anthracycline and a taxane. Early preclinical studies of this new inhibitor of microtubule dynamics showed high antitumor potency towards several human cancer types in vitro and in vivo. Here we extend those early studies by examining the effects of eribulin against a wider spectrum of human tumor xenografts in vivo, and by directly comparing the in vivo effectiveness of different dosing administration schedules.
Eribulin drug review. [2022]Eribulin is an anticancer drug approved for treatment of metastatic breast cancer. This drug is a synthetic derivative from Japanese marine sponge Halichondria okadai. It acts by interfering with the microtubular growth ultimately leading to apoptosis after prolonged mitotic blockage. In patients with metastatic breast cancer refractory to anthracyclines and taxanes, eribulin is one of the life-saving options. Neutropenia, neuropathy and QT prolongation are the most frequent adverse events associated with this drug. Phase I/II trials are also underway in refractory lung, ovarian, pancreatic, bladder, and soft tissue tumors. Larger prospective studies will define the role of this drug in a wide variety of tumors, and the future looks very promising.