Ignite Creation Date:
2025-12-24 @ 12:54 PM
Ignite Modification Date:
2026-02-24 @ 10:56 AM
Study NCT ID:
NCT03168061
Status:
UNKNOWN
Last Update Posted:
2020-02-28
First Post:
2017-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-Escalation and Expansion Trial of NC-6300 in Patients With Advanced Solid Tumors or Soft Tissue Sarcoma
Sponsor:
NanoCarrier Co., Ltd.
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: