Clinical Trial

Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)

Study acronym: APROMISS
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
THIS STUDY IS CURRENTLY RECRUITING PATIENTS WITH ALVEOLAR SOFT PART SARCOMA ONLY AND IS NO LONGER RECRUITING PATIENTS WITH SYNOVIAL SARCOMA OR LEIOMYOSARCOMA. This study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the participants will receive AL3818, one-third of the participants will receive IV dacarbazine.
Protocol Amendment History 24 amendments
This ClinicalTrials.gov record has been amended 24 times since 2017-01-09; most recent amendment 2026-02-23.
Status change: Active, Not Recruiting → Recruiting 2026-02-23
Status change: Recruiting → Active, Not Recruiting 2022-11-01
Status change: Not Yet Recruiting → Recruiting 2017-06-15
Trial Details
NCT Number NCT03016819
Lead Sponsor Advenchen Laboratories, LLC
Conditions Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma, Soft-Tissue Sarcoma
Enrollment 325 participants
Start Date 2017-08-15
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-25