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NCT03016819 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Soft Tissue Sarcoma and Leiomyosarcoma, sponsored by Advenchen Laboratories.

Recruiting
Registry status
Phase 3
Development phase
325
Enrollment target
20
Study locations

NCT03016819 is a Phase 3 study of Soft Tissue Sarcoma and Leiomyosarcoma that is actively recruiting participants, run by Advenchen Laboratories. The registered enrollment target is 325 participants, above the 73-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (345% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT03016819, a Phase 3 study of Soft Tissue Sarcoma and Leiomyosarcoma, is actively recruiting participants, sponsored by Advenchen Laboratories.

RECRUITING
Registry status
Phase 3
Development phase
325 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Soft Tissue Sarcoma Leiomyosarcoma Synovial Sarcoma Alveolar Soft Part Sarcoma

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

2 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, categorized as Phase 3. The registered enrollment target is 325 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 73-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (345% higher). The listed sponsor is Advenchen Laboratories, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Soft Tissue Sarcoma appearing as the primary indexed condition, and to 5 interventions - of which Dacarbazine is the first listed.

NCT03016819 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Other, Florida.

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: Soft Tissue Sarcoma, Leiomyosarcoma, Synovial Sarcoma, Alveolar Soft Part Sarcoma.

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).

Who is sponsoring clinical trial NCT03016819?

This trial is sponsored by Advenchen Laboratories, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.