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 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

Trial Details

NCT ID
NCT03016819
Phase
PHASE3
Sponsor
Advenchen Laboratories, LLC
Status
RECRUITING
Cancer Type
Sarcoma
Interventions
  • AL3818
  • Dacarbazine
  • AL3818 or placebo
  • Midazolam 2 mg for CYP3A4 phenotyping
  • Digoxin (0.25mg)
  • Rosuvastatin 10 mg tablet.
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Los Angeles, California, United States|34.05223,-118.24368
  • Santa Monica, California, United States|34.01949,-118.49138
  • Stanford, California, United States|37.42411,-122.16608
  • Aurora, Colorado, United States|39.72943,-104.83192

Key Eligibility Criteria

  • Written informed consent provided before any study-specific procedures are initiated. Subject must be able to understand and be willing to sign a w…
  • Male or female at least 18 years of age.
  • a. Indication A - ASPS: Histologically proven, unresectable, locally advanced or metastatic alveolar soft part sarcoma. b. CLOSED Indication B - LM…
  • 3\. Open Indication E: Any sarcomas or other solid tumors 4. a. Indication A - ASPS: Subjects with or without prior therapy. b. Indications B - LMS…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Sarcoma Trials on Trialify →