Actively Recruiting
Phase III Study of AL3818 (Anlotinib, Catequentinib) Hydrochloride Monotherapy in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, and Synovial Sarcoma
Led by Advenchen Laboratories, LLC · Updated on 2026-02-25
325
Participants Needed
24
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of AL3818 (anlotinib) hydrochloride in treating metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). This phase 3 study focuses on patients with ASPS receiving open-label AL3818, while those with LMS or SS are randomized to receive either AL3818 or IV dacarbazine. The study also includes pharmacokinetic and exposure-response analyses for AL3818. Participants with ASPS receive AL3818 orally at 12 mg once daily in 21-day cycles, with 14 days on treatment and 7 days off, continuing until disease progression or unacceptable side effects. For LMS and SS, participants are randomly assigned in a 2:1 ratio to either AL3818 or IV dacarbazine, with the option to switch to AL3818 if disease progresses on dacarbazine. The study also includes a subgroup assessing cardiac effects and drug interactions of catequentinib hydrochloride, related to AL3818. During the study, participants undergo regular assessments including imaging scans to measure tumor response using RECIST criteria, laboratory tests to monitor organ function, and electrocardiograms to evaluate heart activity. Researchers track outcomes such as objective response rate, progression-free survival, and duration of response over up to 48 months. Safety is closely monitored, and participants may continue treatment or switch therapies based on disease progression and tolerance. The total study duration varies by participant and includes detailed pharmacokinetic and cardiac safety evaluations.
CONDITIONS
Brief Title
Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must provide written informed consent before starting study procedures.
- Male or female aged 18 years or older.
- Histologically confirmed unresectable, locally advanced or metastatic alveolar soft part sarcoma, leiomyosarcoma, or synovial sarcoma.
- For LMS and SS: must have failed at least one prior line of approved therapy.
- Show clinical or objective disease progression within 6 months after last standard therapy or stopped due to intolerance.
- ECOG performance status of 0 or 1.
- Measurable disease by RECIST 1.1 confirmed by recent CT or MRI within 28 days prior to enrollment.
- Life expectancy of at least 3 months.
- Females of childbearing potential must have a negative pregnancy test and agree to use contraception until 3 months after last study drug.
- Males must agree to use contraception until 3 months after last study drug.
- Adequate hematologic, liver, and kidney function based on lab tests within 28 days prior to enrollment.
- Left ventricular ejection fraction greater than 50% by ECHO or MUGA within 56 days prior to enrollment.
- Controlled blood pressure with systolic <140 mm Hg and diastolic <90 mm Hg, stable on medication if applicable.
You will not qualify if you...
- Prior treatment with or known allergy to AL3818.
- Prior treatment with cediranib for ASPS or dacarbazine for LMS and SS.
- Previous or current cancer different from ASPS, LMS, or SS within 5 years (except certain treated cancers).
- Recent systemic therapy within 21 days or non-cytotoxic therapy within 14 days before enrollment.
- Recent radiotherapy within 14 to 28 days before enrollment.
- Active brain metastases or carcinomatous meningitis.
- Tumors invading large blood vessels in the chest.
- Recent history of gastrointestinal perforation, fistula, or abscess.
- Known bleeding disorders or significant bleeding in past 6 months.
- Severe pulmonary hemorrhage or bleeding within 28 days prior.
- Untreated deep vein thrombosis within 6 months.
- Use of high-dose aspirin within 10 days before study drug.
- Serious non-healing wounds or active ulcers.
- Recent major surgery or significant injury within 7 to 28 days.
- Severe peripheral neuropathy or unresolved toxicity from prior therapy.
- Prolonged QTc interval on ECG.
- Severe uncontrolled diseases including serious heart conditions, infections, liver or kidney failure, uncontrolled diabetes, untreated seizures, or psychiatric disorders.
- Known HIV positive status.
- History of organ transplantation.
- Conditions affecting oral medication intake.
- Pregnant or breastfeeding females.
- Use of certain medications affecting CYP enzymes or QT prolongation within 14 days before enrollment.
- Any other condition that may affect adherence or study objectives as judged by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 21-day cycles until disease progression or unacceptable toxicity
Participants receive AL3818 (Anlotinib) orally once daily in 21-day cycles, with 14 days on treatment and 7 days off, or receive IV dacarbazine on Day 1 of each 21-day cycle. Treatment continues until disease progression or unacceptable toxicity.
Visits occur every 21 days for treatment administration and assessment
Trial Site Locations
Total: 24 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Completed
2
University of California Los Angeles
Los Angeles, California, United States, 90404
Completed
3
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
Actively Recruiting
4
Stanford Medicine Cancer Institute
Stanford, California, United States, 94305
Completed
5
University of Colorado Denver
Aurora, Colorado, United States, 80045
Completed
6
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Completed
7
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Completed
8
Northwestern University
Chicago, Illinois, United States, 60611
Completed
9
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Completed
10
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Completed
11
Washington University St. Louis
St Louis, Missouri, United States, 63130
Completed
12
Columbia University Medical Center
New York, New York, United States, 10032
Withdrawn
13
Thomas Jefferson Hospital - Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Completed
14
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15219
Completed
15
Vanderbilt University
Nashville, Tennessee, United States, 37203
Completed
16
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Completed
17
UW Medicine-Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Completed
18
Beijing Cancer Hospital
Beijing, China
Completed
19
Shanghai Sixth People's Hospital
Shanghai, China
Completed
20
Istituto Nazionale dei Tumori
Milan, Italy
Completed
21
University of Palermo
Palermo, Italy
Completed
22
University Campus Bio-Medico
Rome, Italy
Completed
23
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Completed
24
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Not Yet Recruiting
Research Team
S
Shiying Clinical Trial Manager
J
Judy Clinical Trial Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
7
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