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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

325

Participants

Timeline

Start Date

August 15, 2017

Primary Completion Date

December 31, 2024

Study Completion Date

June 30, 2025

Conditions
Alveolar Soft Part SarcomaLeiomyosarcomaSynovial SarcomaSoft-Tissue Sarcoma
Interventions
DRUG

AL3818

Anlotinib (AL3818) 12 mg orally administered once daily in 21-day cycles (14 days on treatment, 7 days off treatment)

DRUG

Dacarbazine

Dacarbazine 1000 mg/m2 as a 20-120 minute IV infusion on Day 1 of each 21-day treatment cycle

DRUG

AL3818 or placebo

AL3818 or placebo 12 mg orally administered once daily in 21-day cycles (14 days on treatment, 7 days off treatment)

Trial Locations (23)

15219

University of Pittsburgh Medical Center, Pittsburgh

19107

Thomas Jefferson Hospital - Sidney Kimmel Cancer Center, Philadelphia

32224

Mayo Clinic Jacksonville, Jacksonville

33136

University of Miami Sylvester Comprehensive Cancer Center, Miami

37203

Vanderbilt University, Nashville

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

55905

Mayo Clinic Rochester, Rochester

60611

Northwestern University, Chicago

63130

Washington University St. Louis, St Louis

77030

MD Anderson Cancer Center, Houston

80045

University of Colorado Denver, Aurora

85054

Mayo Clinic Arizona, Phoenix

90403

Sarcoma Oncology Center, Santa Monica

90404

University of California Los Angeles, Los Angeles

94305

Stanford Medicine Cancer Institute, Stanford

98109

UW Medicine-Seattle Cancer Care Alliance, Seattle

Unknown

Beijing Cancer Hospital, Beijing

Shanghai Sixth People's Hospital, Shanghai

Istituto Nazionale dei Tumori, Milan

University of Palermo, Palermo

University Campus Bio-Medico, Rome

Hospital de la Santa Creu i Sant Pau, Barcelona

SW3 6JJ

Royal Marsden Hospital, London

Sponsors
All Listed Sponsors
lead

Advenchen Laboratories, LLC

INDUSTRY