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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Primary endpoint(s) modified
    • Eligibility criteria expanded, about 86 words
    • Secondary endpoints revised (5)
  2. Enrollment increased: 29 → 73 participantsv5 Show 4 more changesShow less
    • Study completion pushed from Jul 1, 2029 to Jul 1, 2033
    • Eligibility criteria expanded, about 83 words
    • Study description expanded, about 57 words
    • Study title expanded, about 7 words
  3. Site contact updated
    • Eligibility criteria shortened, about 1 word
    v4
  4. Primary completion date: Jul 1, 2025 to Jul 1, 2028
    • Study completion date: Jul 1, 2026 to Jul 1, 2029
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 30, 2024 to Sep 19, 2024
    • Site details revised
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Northwestern University
387 trials monitored
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Sarcoma
1,026 trials monitored
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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).
Trial Details
NCT Number NCT06571734
Lead Sponsor Northwestern University
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Metastatic Leiomyosarcoma, Unresectable Leiomyosarcoma, Bone Sarcoma, Translocation-associated Soft Tissue Sarcoma, Synovial Sarcomas, Osteosarcoma Metastatic, Ewing Sarcoma, Ewing Sarcoma Metastatic +2 more
Related terms Bone Neoplasms, Leiomyosarcoma, Osteosarcoma, Sarcoma, Ewing, Sarcoma, Synovial
Enrollment 73 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov