Zanzalintinib + Eribulin for Soft Tissue Sarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of two drugs, eribulin and zanzalintinib, to determine if they work better together for treating certain types of advanced soft tissue sarcoma, a rare cancer affecting tissues like muscles and fat. Researchers aim to find out if this combination can help patients live longer without their cancer worsening compared to using eribulin alone. Suitable participants have a specific type of sarcoma that hasn't responded to one or more treatments and is causing ongoing issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot take certain medications like oral anticoagulants, some complementary medicines, or certain investigational agents close to the start of the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found eribulin effective in treating advanced liposarcoma, a type of soft tissue cancer. It extended patients' lives compared to another drug. Eribulin is generally considered safe and is already used for this cancer type.
Research suggests that combining eribulin with zanzalintinib might be safe for patients. Although detailed safety information for this combination is not yet available, eribulin's approval for a similar condition provides some confidence in its safety. As this is an early-phase trial, the main goal is to ensure the combination's safety and determine the right dose. Participants might experience some side effects, but the trial will closely monitor and manage these.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Zanzalintinib and Eribulin for treating soft tissue sarcoma because it offers a new approach by combining two different mechanisms of action. Eribulin is a well-known chemotherapy drug that works by inhibiting cell division, while Zanzalintinib is a newer agent that targets specific kinases involved in tumor growth and survival. This combination aims to enhance the treatment effectiveness by attacking the cancer cells in multiple ways, potentially leading to better outcomes than current treatments like doxorubicin, which primarily use a single mechanism. Additionally, the oral administration of Zanzalintinib offers a more convenient option for patients compared to traditional intravenous chemotherapy.
What evidence suggests that this trial's treatments could be effective for soft tissue sarcoma?
Studies have shown that eribulin can help treat advanced soft tissue sarcoma, particularly liposarcoma, by extending patient survival compared to other treatments. One study found that 46.9% of patients with liposarcoma did not experience cancer progression for at least 12 weeks. This trial will evaluate the combination of eribulin with another drug, zanzalintinib, to determine if it can extend progression-free survival even further. This combination may also be more tolerable and effective than eribulin alone. Early results are promising, but further research is needed to confirm these benefits.12346
Who Is on the Research Team?
Mia C Weiss, M.D.
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
Adults with advanced liposarcoma or leiomyosarcoma who have measurable disease, good performance status, and adequate organ function. They must have tried at least one prior therapy but no more than two. Participants need to use effective contraception and cannot be pregnant or breastfeeding. Those with certain serious health conditions, recent major cardiovascular events, uncontrolled illnesses, or allergies to study drugs are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive zanzalintinib and eribulin in 21-day cycles, with dose escalation to determine the maximum tolerated dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Eribulin
- Zanzalintinib
Trial Overview
The trial is testing the combination of Zanzalintinib and Eribulin versus Eribulin alone in patients with specific sarcomas. The goal is to see if this drug combo can extend the time patients live without their disease getting worse compared to historical data on Eribulin only.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Patients will receive zanzalintinib 60 mg by mouth once daily on Days 1 through 21 and eribulin intravenously on Days 1 and 8 of a 21-day cycle.
Patients will receive zanzalintinib 40 mg by mouth once daily on Days 1 through 21 and eribulin intravenously on Days 1 and 8 of a 21-day cycle.
Patients will receive zanzalintinib 20 mg by mouth once daily on Days 1 through 21 and eribulin intravenously on Days 1 and 8 of a 21-day cycle.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Exelixis
Industry Sponsor
Michael M. Morrissey
Exelixis
Chief Executive Officer since 2010
PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin
Vicki L. Goodman
Exelixis
Chief Medical Officer since 2022
MD
Citations
Zanzalintinib + Eribulin for Soft Tissue Sarcoma
Eribulin has shown effectiveness in treating advanced liposarcoma, a type of soft tissue sarcoma, by improving overall survival compared to another drug, ...
2.
clinicaltrials.gov
clinicaltrials.gov/study/NCT06957431?cond=Cancer&aggFilters=funderType%3Aindustry%2CstudyType%3AintStudy Details | Zanzalintinib Combined With Eribulin in ...
The investigators hypothesize that the combination of eribulin and zanzalintinib will be tolerable and lead to improved progression-free survival (PFS) as ...
Efficacy and safety of eribulin in the treatment of advanced ...
The results originally stated: “10 out of 33 (30.3%) patients with L-type sarcomas had achieved PR and the median PFS was 2.67 months, 1 out of ...
4.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT06957431/zanzalintinib-combined-with-eribulin-in-advanced-liposarcoma-and-leiomyosarcomaZanzalintinib Combined With Eribulin in Advanced ...
The investigators hypothesize that the combination of eribulin and zanzalintinib will be tolerable and lead to improved progression-free ...
Efficacy of Eribulin in Soft Tissue Sarcomas - PMC
The best results were found in the LPS group, with 15 patients (46.9%) being progression free at 12 weeks. This was followed by 12 (31.6%) in ...
PMC - PubMed Central
However, the objective response rate (ORR) ranges only from 5 to 20%, with a poor median progression-free survival (mPFS) of 4.2 months [3].
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