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NanoCarrier NC-6300-001 (Sarcoma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out how safe and effective a study drug called Nanoparticle Epirubicin (NC-6300) is for men and women with advanced cancer

What is the Condition Being Studied?

Advanced solid tumors or advanced, metastatic, or unresectable soft tissue sarcoma

Who Can Participate in the Study?

Adult men and women who have:

Part 1: a diagnosis of advanced solid tumor, including sarcomas that are not responding to standard therapy

Part 2: a diagnosis of advanced, unresectable or metastatic soft tissue sarcoma not eligible for curative treatment with surgery or radiation.

Age Group
Adults

What is Involved?

This study is divided into two parts.

Part 1 is looking for the best dose of a study drug called NC-6300 for people with solid tumors.

Part 2 will look at the activity and safety of the drug when combined with Olaratumab in patients with soft tissue sarcoma.

In Part 1, patients will receive an intravenous infusion of NC-6300 on day 1 of each 21-day cycle until they have bad side effects or their disease gets worse.

In Part 2, patients will receive the best dose identified in Part 1 on day 1 of each 21 day cycle plus Olaratumuab on days 1 and 8 of each cycle until they have bad side effects or their disease gets worse.

All patients will go through a screening period with physical exams, testing and questionnaires.

While receiving the study drug, all patients will have testing on days 1, 8 and 15 of each cycle.

Patients in Part 1 will also have several blood tests throughout the day on day 1 of each cycle.

Study Details

Full 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
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00082899
NCT:NCT03168061
Phase
Phase I/II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698