Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04260360
Recruitment Status : Withdrawn (Not initiated)
First Posted : February 7, 2020
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
NanOlogy, LLC

Tracking Information
First Submitted Date  ICMJE February 5, 2020
First Posted Date  ICMJE February 7, 2020
Last Update Posted Date August 4, 2020
Estimated Study Start Date  ICMJE April 2020
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2020)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2020)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma
Official Title  ICMJE Phase 1 Trial Evaluating the Safety and Tolerability of NanoDoce® Intratumoral Injection in Subjects With Localized Renal Cell Carcinoma
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Renal Cell Carcinoma
  • Kidney Cancer
  • Adenocarcinoma of Kidney
  • Adenocarcinoma, Renal
  • Renal Cell Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: NanoDoce
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.
Intervention: Drug: NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 31, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2020)
15
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed informed consent;
  • Age ≥18 years;
  • Localized T1a renal cell carcinoma;
  • Maximum tumor volume of 25.0 mL;
  • Performance Status (ECOG) 0-2;
  • Life expectancy of at least 6 months;
  • Adequate marrow, liver, and renal function;

    • ANC ≥ 1.5 x 109/L
    • Hemoglobin ≥ 9.5 grams/dL
    • Platelets ≥ 75 x 109/L
    • Total bilirubin ≤ 1.5x institutional ULN
    • AST/ ALT ≤ 2.5x institutional ULN
    • Creatinine ≤ 1.5x institutional ULN
    • eGFR < 60 mL/min/1.73m2
  • Adequate method of birth control.

Exclusion Criteria:

  • Renal cyst;
  • Multifocal or bilateral renal mass;
  • Known hypersensitivity to any of the study drug or reconstitution components;
  • Pregnant or breastfeeding female;
  • Administration of an investigational product in a clinical trial within 3 months prior to consent;
  • Investigator's opinion of subject's probable noncompliance or inability to understand the trial and/or give adequate informed consent;
  • Known drug or alcohol abuse.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04260360
Other Study ID Numbers  ICMJE NANODOCE-2018-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NanOlogy, LLC
Study Sponsor  ICMJE NanOlogy, LLC
Collaborators  ICMJE US Biotest, Inc.
Investigators  ICMJE
Study Director: Rose Marie Cavanna-Mast, RT, CCRA US Biotest, Inc.
PRS Account NanOlogy, LLC
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP