Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-31 @ 7:46 PM
Study NCT ID:
NCT04260360
Status:
WITHDRAWN
Last Update Posted:
2020-08-04
First Post:
2020-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma
Sponsor:
NanOlogy, LLC
Organization:
Study Overview
Official Title:
Phase 1 Trial Evaluating the Safety and Tolerability of NanoDoce® Intratumoral Injection in Subjects With Localized Renal Cell Carcinoma
Status:
WITHDRAWN
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not initiated
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT04060628
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
None
Brief Summary:
This study evaluates the use of NanoDoce injected directly into tumors in the kidney of people with renal cell carcinoma.
Detailed Description:
NanoDoce is very small (submicron) particles of the chemotherapy drug, docetaxel, 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 docetaxel will be injected directly into tumors in the kidney of people with renal cell carcinoma that is localized to (has not spread beyond) the kidney. All subjects in this study will receive NanoDoce and will be evaluated to see if NanoDoce is safe.
Study Oversight
Has Oversight DMC:
False
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?: