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Spots Global Cancer Trial Database for Dose-Escalation and Expansion Trial of NC-6300 in Patients With Advanced Solid Tumors or Soft Tissue Sarcoma

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Trial Identification

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

Interventions

NC 6300

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Atsushi Osada

Affiliation: NanoCarrier Co., Ltd.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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