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XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma, Bone Sarcoma or Translocation-associated Soft Tissue Sarcoma

ConditionsMetastatic LeiomyosarcomaUnresectable LeiomyosarcomaBone SarcomaTranslocation-associated Soft Tissue SarcomaSynovial SarcomasOsteosarcoma MetastaticEwing SarcomaEwing Sarcoma MetastaticSarcoma MetastaticSarcoma of Bone
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

This phase II trial tests how well zanzalintinib (XL092) works in treating patients with leiomyosarcoma that has spread from where it first started to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Leiomyosarcomas are a type sarcoma that can occur in any location in the body, such as the uterus or in the abdomen. Current standard treatment for leiomyosarcoma only shows a progression-free survival of 4-6 months. XL092, a tyrosine kinase inhibitor, interferes with cell communication and growth and may prevent tumor growth. Giving XL092 may kill more tumor cells in patients with metastatic or unresectable leiomyosarcoma. The trial has now been expanded to treat additional sarcoma types that are sensitive to tyrosine kinase inhibitors (TKIs) such as translocation-associated soft tissue sarcoma (such as synovial sarcoma), and bone sarcoma (including osteosarcoma and Ewing sarcoma).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must have histologically confirmed leiomyosarcoma that has been clinically determined to be metastatic or unresectable. Pathology must have been reviewed at a National Comprehensive Cancer Network (NCCN) designated cancer center such as Northwestern University's Lurie Cancer Center.

Patients must have undergone at least 2 or more lines of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI).

Patients must have histologically confirmed diagnosis of metastatic or unresectable bone sarcoma. Pathology must have been reviewed at a National Comprehensive Cancer Network (NCCN) designated cancer center such as Northwestern University's Lurie Cancer Center.

Patients must have undergone at least 1 line of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI).

Disqualifiers

Patients who have received previous treatment with XL092.

Patients who have received any type of small-molecule kinase inhibitor (including an investigational kinase inhibitor) within 14 days prior to study day 1 treatment.

Patients who have received > 2 prior tyrosine kinase inhibitor therapies as anticancer treatments.

Patients who have had prior chemotherapy, or radiation therapy within 4 weeks prior to start of study treatment unless they have recovered from their prior therapy (toxicity and/or complications) such that they now meet all other eligibility criteria

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Echocardiography

    Procedure/Surgery

    Undergo ECHO

  • Multigated Acquisition Scan

    Procedure/Surgery

    Undergo MUGA

  • Zanzalintinib

    Drug

    Given PO

Treatment groups

73 Participants
are divided into 1 treatment group
Group A: Treatment (XL092)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

PFS will be defined as progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.other documented clinical or radiographic progression per physician judgment, or death due to disease.

Time frame
Up to 6 months

Secondary outcomes

1

Median PFS

Median PFS will be calculated as the overall PFS time as the time that elapses between initiation of trial therapy and first documented disease progression or death from any cause, whichever come first.

Time frame
Up to 5 years
2

Overall survival (OS)

OS will be calculated as the time that elapses between the day of patient registration and death from any cause.

Time frame
Up to 5 years
3

Overall response rate (ORR)

ORR will be defined as the proportion of treated patients who experience an objective response (confirmed complete response or confirmed partial response per RECIST v 1.1.).

Time frame
Up to 5 years
4

Duration of response (DOR)

DOR will be calculated as the time that elapses between the day of first documented response to trial therapy (confirmed CR or confirmed PR, whichever is first recorded) and subsequent disease progression. DOR will be estimated as median and interquartile range or mean and a confidence interval depending on the distribution.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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