Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

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

NCT03016819 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Dacarbazine
  • DRUG AL3818
  • DRUG AL3818 or placebo
  • DRUG Midazolam 2 mg for CYP3A4 phenotyping
  • DRUG Digoxin (0.25mg)

Study Locations (20)

California

  • University of California Los Angeles — Los Angeles
  • Sarcoma Oncology Center — Santa Monica
  • Stanford Medicine Cancer Institute — Stanford

Other

  • Beijing Cancer Hospital — Beijing
  • Shanghai Sixth People's Hospital — Shanghai
  • Istituto Nazionale dei Tumori — Milan

Florida

  • Mayo Clinic Jacksonville — Jacksonville
  • University of Miami Sylvester Comprehensive Cancer Center — Miami

Pennsylvania

  • Thomas Jefferson Hospital - Sidney Kimmel Cancer Center — Philadelphia
  • University of Pittsburgh Medical Center — Pittsburgh

Arizona

  • Mayo Clinic Arizona — Phoenix

Colorado

  • University of Colorado Denver — Aurora

Illinois

  • Northwestern University — Chicago

Michigan

  • University of Michigan Comprehensive Cancer Center — Ann Arbor

Trial Details

FieldValue
Enrollment Target 325 participants
Start Date 2017-08-15
Est. Completion 2028-12
Phase Phase 3

Sponsor

Advenchen Laboratories

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03016819

The ClinicalTrials.gov registry entry for NCT03016819 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 325 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advenchen Laboratories, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Leiomyosarcoma appearing as the primary indexed condition, and to 5 interventions — of which Dacarbazine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03016819 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Other, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03016819 about?

NCT03016819 is a clinical study titled "Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)". 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 pa...

What is the current status of trial NCT03016819?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 325 participants. The study started on 2017-08-15. Estimated completion is 2028-12.

What conditions does trial NCT03016819 study?

This clinical trial studies the following conditions: Leiomyosarcoma, Synovial Sarcoma, Alveolar Soft Part Sarcoma, Soft-Tissue Sarcoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03016819?

The interventions under investigation include: Dacarbazine (DRUG), AL3818 (DRUG), AL3818 or placebo (DRUG), Midazolam 2 mg for CYP3A4 phenotyping (DRUG), Digoxin (0.25mg) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03016819?

This trial is sponsored by Advenchen Laboratories, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03016819 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial