Zanzalintinib Combined With Eribulin in Advanced Liposarcoma and Leiomyosarcoma
A Phase I Trial of Zanzalintinib Combined With Eribulin in Advanced Liposarcoma and Leiomyosarcoma
Sponsor: Washington University School of Medicine + Exelixis
No open prediction endpoints
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Primary Endpoints (CT.gov)
Number of adverse events experienced by participants
Time frame: From start of treatment through 30 days after completion of treatment (estimated to be 25 months)
Maximum tolerated dose (MTD)/recommended phase II dose (RP2D)
Time frame: Through cycle 1 of treatment (each cycle is 21 days)
Secondary Endpoints
Overall response rate (ORR) by RECIST 1.1
Progression-free survival (PFS)
Median Overall survival (OS)
Eligibility Criteria
Inclusion Criteria: * 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. * ECOG performance status ≤ 1 * Adequate bone marrow and organ function within 14 days before first dose of study treatment as defined below: * Absolute neutrophil count ≥ 1.5 K/cumm without granulocyte colony-stimulating factor support within 2 weeks of collection * Platelets ≥ 100 K/cumm without transfusion within 2 weeks of collection * Hemoglobin ≥ 9.0 g/dL without transfusion within 2 weeks of collection * INR ≤ 1.5 x ULN and aPTT ≤ 1.2 x ULN; for subjects on Factor Xa inhibitors, this criterion does not apply. * Total bilirubin ≤ 1.5 x IULN (for subjects with Gilbert's disease, ≤ 3.0 x IULN) * AST(SGOT)/ALT(SGPT)/alkaline phosphatase (ALP) ≤ 3.0 x IULN (for subjects with documen…
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