Zanzalintinib Combined With Eribulin in Advanced Liposarcoma and Leiomyosarcoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
The investigators hypothesize that the combination of eribulin and zanzalintinib will be tolerable and lead to improved progression-free survival (PFS) as compared to eribulin alone based on historical data.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically proven diagnosis of unresectable or metastatic leiomyosarcoma or adipocytic sarcoma.
Progressed on at least 1 line of prior therapy and have received no more than 4 lines of prior therapy.
Measurable disease per RECIST 1.1.
At least 18 years of age.
Disqualifiers
Pure well-differentiated liposarcoma or low grade leiomyosarcoma.
Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
Prior treatment with zanzalintinib.
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
Trial design
Design model
Sequential
Treatments tested in this trial
Zanzalintinib
DrugSupplied by Exelixis, Inc.
Eribulin
Drug1.1 mg/m\^2 dose.
Treatment groups
18 Participants
are divided into 3 treatment groupsGroup A: Dose Level 1 (starting dose): Zanzalintinib + EribulinExperimental treatment 2 interventions
Group B: Dose Level 2: Zanzalintinib + EribulinExperimental treatment 2 interventions
Group C: Dose Level -1: Zanzalintinib + EribulinExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of adverse events experienced by participants
Graded using CTCAE version 5.0.
Time frame
From start of treatment through 30 days after completion of treatment (estimated to be 25 months)2
Maximum tolerated dose (MTD)/recommended phase II dose (RP2D)
The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. Dose escalations will proceed until the MTD has been reached or, if the MTD is not reached, until 6 patients have been treated successfully at the highest dose level (which will then be termed the recommended phase II dose (RP2D)).
Time frame
Through cycle 1 of treatment (each cycle is 21 days)Secondary outcomes
1
Overall response rate (ORR) by RECIST 1.1
* ORR is defined as number of patients with complete response (CR) or partial response (PR). * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame
Through completion of treatment (estimated to be 24 months)2
Progression-free survival (PFS)
* PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Time frame
6 months from start of treatment3
Median Overall survival (OS)
\- OS is defined as the duration of time from start of treatment to time of death.
Time frame
Through completion of follow-up (estimated to be 7 years)4
Kaplan-Meier Estimate of Overall survival (OS)
\- OS is defined as the duration of time from start of treatment to time of death.
Time frame
24 months from start of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
Exelixis
Collaborator
Source ClinicalTrials.gov