OncoMatch/Clinical Trials/NCT03016819
Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)
Is NCT03016819 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for alveolar soft part sarcoma.
Treatment: AL3818 · Dacarbazine · Midazolam 2 mg for CYP3A4 phenotyping · Digoxin (0.25mg) · Rosuvastatin 10 mg tablet. — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anthracycline
Indication C - SS: Subjects previously treated with at least one prior line of standard systemic therapy, including first-line anthracycline containing regimen (except if medically contraindicated or refused by subject). Indication D - LMS: ...have been treated any line with an anthracycline.
Cannot have received: AL3818 (AL3818)
Prior treatment with or have known hypersensitivity to AL3818
Cannot have received: cediranib (cediranib)
Indication A - ASPS: Prior treatment with cediranib
Cannot have received: dacarbazine (dacarbazine)
Indication B - LMS: Prior treatment with or have known hypersensitivity to dacarbazine. Indication C - SS: Prior treatment with or have known hypersensitivity to dacarbazine.
Cannot have received: anlotinib (anlotinib)
Indication D - LMS: Prior treatment with anlotinib
Lab requirements
Blood counts
Platelet count >100,000/mm3, hemoglobin >9 g/dL, ANC >1,500/mm3, INR/aPTT <1.5x ULN (unless on LMWH/heparin and no prior abnormality)
Kidney function
Serum creatinine <1.5x ULN, GFR >30 ml/min/1.73m2 or CrCl >60 ml/min or by 24h urine; urine protein <30 mg/dL (if >30, 24h urine <1000 mg/24h or spot urine protein/creatinine ratio <1.0)
Liver function
Total bilirubin < ULN (unless Gilbert's disease <3), ALT/AST <2.5x ULN (<5x ULN with liver involvement), alkaline phosphatase <2.5x ULN (<5x ULN with liver involvement)
Cardiac function
LVEF >50% by ECHO or MUGA within 56 days of enrollment
Adequate hematologic, hepatic and renal function as assessed by the following laboratory requirements... LVEF >50% by ECHO or MUGA
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stanford Medicine Cancer Institute · Stanford, California
- Mayo Clinic Arizona · Phoenix, Arizona
- University of California Los Angeles · Los Angeles, California
- Sarcoma Oncology Center · Santa Monica, California
- University of Colorado Denver · Aurora, Colorado
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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