Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around
Principal Investigator
by Arun Singh, MD (ucla)

Description

Summary

To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen.

Official Title

A Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adults With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (INVINCIBLE-3)

Keywords

Sarcoma,Soft Tissue, Sarcoma, Trabectedin, INT230-6, Eribulin, Pazopanib, INT230-6 Monotherapy

Eligibility

Locations

  • University of California Los Angeles (UCLA) - Santa Monica Cancer Care accepting new patients
    Santa Monica California 90404 United States
  • Sarcoma Oncology Center accepting new patients
    Santa Monica California 90403 United States
  • USC/Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Lead Scientist at University of California Health

  • Arun Singh, MD (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 70 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Intensity Therapeutics, Inc.
ID
NCT06263231
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 333 study participants
Last Updated