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Brief Title: Dose-Escalation and Expansion Trial of NC-6300 in Patients With Advanced Solid Tumors or Soft Tissue Sarcoma
Official Title: A Phase 1b/2 Dose-Escalation and Expansion Trial of NC-6300 (Nanoparticle Epirubicin) in Patients With Advanced Solid Tumors or Advanced, Metastatic, or Unresectable Soft Tissue Sarcoma
Study ID: NCT03168061
Brief Summary: The goal of this study is to find the highest tolerated dose of NC-6300 that can be given to patients with advanced solid tumors or soft tissue sarcoma. The safety and tolerability of the drug will also be studied.
Detailed Description: The first part of the study will determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and the recommended Phase 2 (RPII) dose of NC-6300. The second part of the study will assess the activity and tolerability of NC-6300 in patients with soft tissue sarcoma.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope National Medical Center, Duarte, California, United States
University of California Los Angeles, Santa Monica, California, United States
Sarcoma Oncology Research Center, LLC., Santa Monica, California, United States
Comprehensive Cancer Centers of Nevada - USOR, Las Vegas, Nevada, United States
Montefiore Medical Center, Bronx, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Duke Cancer Institute, Durham, North Carolina, United States
Name: Atsushi Osada
Affiliation: NanoCarrier Co., Ltd.
Role: STUDY_DIRECTOR