Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-04-23 @ 1:04 PM
Study NCT ID:
NCT04314895
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2020-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of NanoPac Intratumoral Injection in Lung Cancer
Sponsor:
NanOlogy, LLC
Organization:
Study Overview
Official Title:
Phase 2 Trial Evaluating the Safety and Tolerability of Intratumoral Injections of NanoPac® With Standard of Care Therapy in Subjects With Lung Cancer
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03756311
Has Expanded Access, NCT# Status:
TEMPORARILY_NOT_AVAILABLE
Acronym:
None
Brief Summary:
This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer.
Detailed Description:
NanoPac is very small (submicron) particles of the chemotherapy drug, paclitaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, the submicron particle paclitaxel will be injected directly into tumors in the lungs of people with small cell or non-small cell lung cancer. All subjects in this study will receive NanoPac and will be evaluated to see if NanoPac is safe and has an effect on the tumor within the lung.
Study Oversight
Has Oversight DMC:
True
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?: