Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT04260360|
Recruitment Status : Withdrawn (Not initiated)
First Posted : February 7, 2020
Last Update Posted : August 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma Kidney Cancer Adenocarcinoma of Kidney Adenocarcinoma, Renal Renal Cell Cancer||Drug: NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension||Phase 1|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Trial Evaluating the Safety and Tolerability of NanoDoce® Intratumoral Injection in Subjects With Localized Renal Cell Carcinoma|
|Estimated Study Start Date :||April 2020|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||October 2022|
Intratumoral injection of NanoDoce (2.0 to 6.0 mg/mL) at a volume not to exceed 5.0 mL. NanoDoce will be administered on up to two occasions with at least 4 weeks between doses.
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.
Other Name: docetaxel
- Number of participants with treatment emergent adverse events [ Time Frame: Day 1 to 180 days post-last NanoDoce injection ]Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
- Concentration of docetaxel in the systemic circulation post-injection [ Time Frame: Screening, Day 1, Day 2, Day 15, Day 27, Day 30, Day 31, Day 45, Month 2, Month 3, Month 4, Month 5, and 180 days post-last NanoDoce injection ]Pharmacokinetic samples will be obtained on the days of NanoDoce injection and other clinic visits
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04260360
|Study Director:||Rose Marie Cavanna-Mast, RT, CCRA||US Biotest, Inc.|