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Protocol No.NC-6300-001Principal InvestigatorGrilley-Olson, Juneko
PhasePhase I/II
Oncology GroupPhase 1
Management GroupClinical Protocol Office; Phase 1 CPO
Age GroupAdultScopeNational
TitleA 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
DescriptionWhat is the purpose of this study? This is an early phase clinical trial that will help decide the best dose and the safety of an experimental anti-cancer medicine. The purpose of this research study is to find out what impact (good and/or bad) this experimental chemotherapy, Nanoparticle Epirubicin (NC-6300) has on your tumor. The Nanoparticle Epirubicin is an experimental drug. Nanoparticle Epirubicin is made from the active part of Epirubicin which has been approved to treat cancer. This form of Epirubicin is carried through the bloodstream by tiny particles called nanoparticles and into cancer cells. There are 2 parts to this study: Part 1 of this clinical research study is done to decide the best dose that can be tolerated, as well as, the safest dose to use in patients with solid tumor cancer. Part 2 of this clinical research study will be looking at the activity and the safety of the drug in patients with soft tissue sarcoma in addition to using the drug olaratumab. Patients in Part 1 who were not assigned to the NC-6300 dose identified as the recommended dose for Part 2 and who are still receiving treatment when the recommended dose is determined will have the option to receive NC-6300 at the recommended dose for subsequent treatment cycles. If you are one of the patients from Part 1 who meet these criteria, your study doctor will discuss this option with you. If you agree to receive the recommended dose determined in this part of the study; you will be asked to sign a new consent form before receiving the recommended dose. Patients in Part 2 of the study will receive the recommended dose based on the results of the Part 1 study. Your study doctor will discuss the dose that you will receive during participation of Part 2. In addition to receiving the study drug, you will receive olaratumab as part of your therapy for your disease. If you are participating in Part 2 of this study it is important for you to understand that you may be receiving chemotherapy for the first time on this study and that there are already approved standard therapies that have shown clinical benefit available to you without participating on this clinical trial. These therapies include doxorubicin with or without olaratumab, doxorubicin with or without ifosfamide, pegylated liposomal doxorubicin, epirubicin, or a gemcitabine based regimen if you cannot tolerate an anthracycline.
Applicable Disease SitesBones and Joints
Brain and Nervous System
Breast - Male
Cervix Uteri
Corpus Uteri
Eye and Orbit
Lip, Oral Cavity and Pharynx
Melanoma, Skin
Small Intestine
Soft Tissue
Urinary Bladder
Drugs InvolvedNC-6300
Participating InstitutionsUNC-CH
Eligibility DocumentNC-6300-001_Eligibility Packet_05-11-2018.pdf
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