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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: Recruiting Phase 3 study of Soft Tissue Sarcoma and Leiomyosarcoma, sponsored by Advenchen Laboratories.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine ORR in subjects with ASPS, defined as percentage of subjects who achieve a Complete Response (CR) or Partial Response (PR) as best responses according to RECIST 1.1 as evaluated by a blinded independent radiological review (BICR).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2017-08-15 |
| Est. Completion | 2028-12 |
| Phase | Phase 3 |
What NCT03016819 shows while recruiting
NCT03016819 is an interventional study that assigns participants to a tested intervention. The registered 325 participants enrollment target is mid-sized for trials with a published cap, above the 73-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (345% higher).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Soft Tissue Sarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03016819's enrollment target sits among peer trials
325 2nd of 55 the highest of 55 other Soft Tissue Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Soft Tissue Sarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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-
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-
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