NCT04260360

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2020

Typical duration for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

August 4, 2020

Status Verified

July 1, 2020

Enrollment Period

2.2 years

First QC Date

February 5, 2020

Last Update Submit

July 31, 2020

Conditions

Renal Cell CarcinomaKidney CancerAdenocarcinoma of KidneyAdenocarcinoma, RenalRenal Cell Cancer

Keywords

docetaxel

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment emergent adverse events

    Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)

    Day 1 to 180 days post-last NanoDoce injection

Secondary Outcomes (1)

  • Concentration of docetaxel in the systemic circulation post-injection

    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

Study Arms (1)

NanoDoce

EXPERIMENTAL

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

Interventions

NanoDoce (sterile nanoparticulate docetaxel) Powder for SuspensionDRUG

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.

Also known as: docetaxel
NanoDoce

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Renal CellKidney Neoplasms

Interventions

PowdersSuspensionsDocetaxel

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical PreparationsColloidsComplex MixturesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Rose Marie Cavanna-Mast, RT, CCRA

    US Biotest, Inc.

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 7, 2020

Study Start

April 1, 2020

Primary Completion

June 1, 2022

Study Completion

October 1, 2022

Last Updated

August 4, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share