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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Recruitment Status : Withdrawn (Not initiated)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
Sponsor:
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
NanOlogy, LLC

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

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 ...

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
NanOlogy, LLC
US Biotest, Inc.
Investigators
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Study Director: Rose Marie Cavanna-Mast, RT, CCRA US Biotest, Inc.
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Responsible Party: NanOlogy, LLC
ClinicalTrials.gov Identifier: NCT04260360    
Other Study ID Numbers: NANODOCE-2018-01
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NanOlogy, LLC:
docetaxel
Additional relevant MeSH terms:
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Carcinoma
Adenocarcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action