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Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma

NCT04260360 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-08-04

No results posted yet for this study

Summary

This study evaluates the use of NanoDoce injected directly into tumors in the kidney of people with renal cell carcinoma.

Conditions

Interventions

DRUG

NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension

NanoDoce is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate docetaxel nanoparticles within a well-characterized particle-size distribution. Prior to administration, the NanoDoce powder in vial is suspended with a sterile solution of Polysorbate 80 (0.0075% - 0.0375% (w/w))/Ethanol (0.06% - 0.3% (w/w)) in 0.9% Sodium Chloride for injection.

Sponsors & Collaborators

  • US Biotest, Inc.

    collaborator INDUSTRY

  • NanOlogy, LLC

    lead INDUSTRY

Principal Investigators

  • Rose Marie Cavanna-Mast, RT, CCRA · US Biotest, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2022-06-30
Completion
2022-10-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04260360 on ClinicalTrials.gov