Neoplasms

All Conditions

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Epirubicin

In Part 1, patients will receive an intravenous infusion of NC-6300 at escalating doses starting at a fixed dose on Day 1 of a 21-day cycle. After enrollment of the initial patient, the first patient in each cohort will not be enrolled until all patients at the immediately lower cohort have completed at least 1 full 21-day cycle. In Part 1, patients will continue to receive treatment until they experience disease progression, experience unacceptable toxicity, or withdraw voluntarily.

Part 2 will begin after the RPII dose of NC-6300 is identified. All patients in Part 2 will receive NC-6300 at the RPII dose.

Part 1: NC-6300 at escalating doses starting at a fixed dose Part 2: NC-6300 at the RPII dose

NC 6300

Amanda Knight

Arnavaz Eduljee

Sant Chawla

Juneko Grilley-Olson

Richard Riedel

Atsushi Osada

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.

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.

Dose-Escalation and Expansion Trial of NC-6300 in Patients With Advanced Solid Tumors or Soft Tissue Sarcoma

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

To characterize the pharmacokinetics of NC-6300.

To evaluate the overall safety and tolerability of NC-6300 when administered as a single agent

To evaluate the change in health-related quality of life following NC-6300 administration

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Dose-Escalation and Expansion Trial of NC-6300 in Patients With Advanced Solid Tumors or Soft Tissue Sarcoma	NCT03168061	Solid Tumor Soft Tissue Sar... Metastatic Sarc... Sarcoma	NC 6300	18 Years - 80 Years	NanoCarrier Co., Ltd.
Dose-Escalation and Expansion Trial of NC-6300 in Patients With Advanced Solid Tumors or Soft Tissue Sarcoma	NCT03168061	Solid Tumor Soft Tissue Sar... Metastatic Sarc... Sarcoma	NC 6300	18 Years - 80 Years	NanoCarrier Co., Ltd.

Spots Global Cancer Trial Database for nc 6300

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Spots Global Cancer Trial Database for nc 6300

Every month we try and update this database with for nc 6300 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nc 6300 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.