New ASPS Trial: A​​PROMISS – A Phase III Trial of Anlotinib for Patients with Alveolar Soft Part Sarcoma and Other Sarcomas

OPEN NOW: ​​​APROMISS – A Phase III Study of AL3818 (Anlotinib) Hydrochloride Monotherapy in Subjects With Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma​​

Sponsored by: ​Advenchen Laboratories, LLC.

ClinicalTrials.gov Identifier: ​NCT03016819

​Anlotinib (AL3818), a tyrosine kinase inhibitor, is an investigational drug being evaluated in the treatment of ​Alveolar ​Soft ​Part ​Sarcoma​ and other sarcomas. ​Anlotinib was studied in ​soft tissue sarcomas in a phase 2 trial and demonstrated encouraging results in ​Alveolar ​Soft ​Part ​Sarcoma. The results were presented at the ASCO 2016 annual meeting. The promising phase 2 results paved the way for APROMISS, the phase 3 study, which is currently open to recruitment in the United States with plans to open globally in Japan and Europe.

The objective of APROMISS is to assess the effectiveness and safety of ​Anlotinib in subjects with metastatic or advanced​ Alveolar ​Soft ​Part ​Sarcoma​ and other sarcomas. The FDA also granted orphan drug designation to ​Anlotinib for the the potential treatment of soft tissue​ sarcoma, designation which is granted for drugs intended for diseases or conditions that affect fewer than 200,000 people in the United States.

Eligibility: Individuals​ 18 years of age and older with​ locally advanced or metastatic ​Alveolar ​Soft ​Part ​Sarcoma​ who are not candidates for surgical resection​. Please note that other eligibility criteria do apply – for further details please go to​ the ClinicalTrials.gov page at​ ​https://clinicaltrials.gov/ ct2/show/NCT03016819.

Contact:
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​Melissa Chen ​at: melissac@advenchen.com​

Judy Chen ​at:​ judyc@advenchen.com

Locations: ​Miami, FL; Ann Arbor, Michigan; Los Angeles, CA; Stanford, CA

_____________________________________________________

Yosef Landesman, Ph.D.
President & Cancer Research Director
Cure Alveolar Soft Part Sarcoma International (iCureASPS)
e-mail: landesmany@yahoo.com