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Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma

Primary Purpose

Renal Cell Carcinoma, Kidney Cancer, Adenocarcinoma of Kidney

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension
Sponsored by
NanOlogy, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring docetaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    NanoDoce

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Number of participants with treatment emergent adverse events
    Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)

    Secondary Outcome Measures

    Concentration of docetaxel in the systemic circulation post-injection
    Pharmacokinetic samples will be obtained on the days of NanoDoce injection and other clinic visits

    Full Information

    First Posted
    February 5, 2020
    Last Updated
    July 31, 2020
    Sponsor
    NanOlogy, LLC
    Collaborators
    US Biotest, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04260360
    Brief Title
    Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma
    Official Title
    Phase 1 Trial Evaluating the Safety and Tolerability of NanoDoce® Intratumoral Injection in Subjects With Localized Renal Cell Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Not initiated
    Study Start Date
    April 2020 (Anticipated)
    Primary Completion Date
    June 2022 (Anticipated)
    Study Completion Date
    October 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NanOlogy, LLC
    Collaborators
    US Biotest, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Cell Carcinoma, Kidney Cancer, Adenocarcinoma of Kidney, Adenocarcinoma, Renal, Renal Cell Cancer
    Keywords
    docetaxel

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    NanoDoce
    Arm Type
    Experimental
    Arm Description
    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 Type
    Drug
    Intervention Name(s)
    NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension
    Other Intervention Name(s)
    docetaxel
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Number of participants with treatment emergent adverse events
    Description
    Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
    Time Frame
    Day 1 to 180 days post-last NanoDoce injection
    Secondary Outcome Measure Information:
    Title
    Concentration of docetaxel in the systemic circulation post-injection
    Description
    Pharmacokinetic samples will be obtained on the days of NanoDoce injection and other clinic visits
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rose Marie Cavanna-Mast, RT, CCRA
    Organizational Affiliation
    US Biotest, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma

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