Return to Clinical Trials Search Results

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

Primary Objectives: The primary objectives of this study are: -Part 1: In the dose-escalation part of the study, to determine the MTD and RPII dose of NC-6300 -Part 2: In the expansion part of the study, to evaluate the activity of NC-6300 at the RPII dose compared to historical controls in patients with first-line or relapsed or refractory, locally advanced, unresectable, and/or metastatic soft tissue sarcoma Secondary Objectives The secondary objectives of this study are: -To evaluate the overall safety and tolerability of NC-6300 when administered as a single agent -To evaluate the activity of NC-6300 across all dose levels in patients with advanced solid tumors -To evaluate the change in health-related quality of life (QoL) following NC-6300 administration Exploratory Objective: -To characterize the pharmacokinetics of NC-6300

Primary Objectives: The primary objectives of this study are: -Part 1: In the dose-escalation part of the study, to determine the MTD and RPII dose of NC-6300 -Part 2: In the expansion part of the study, to evaluate the activity of NC-6300 at the RPII dose compared to historical controls in patients with first-line or relapsed or refractory, locally advanced, unresectable, and/or metastatic soft tissue sarcoma Secondary Objectives The secondary objectives of this study are: -To evaluate the overall safety and tolerability of NC-6300 when administered as a single agent -To evaluate the activity of NC-6300 across all dose levels in patients with advanced solid tumors -To evaluate the change in health-related quality of life (QoL) following NC-6300 administration Exploratory Objective: -To characterize the pharmacokinetics of NC-6300