Clinical trial · Interventional

Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma

Phase 1 Trial Evaluating the Safety and Tolerability of NanoDoce® Intratumoral Injection in Subjects With Localized Renal Cell Carcinoma

NCT04260360CI-TRIAL-00046397withdrawnPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Not initiated

Summary

Brief summary (as posted)

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

Conditions

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Adenocarcinoma of Kidney	Renal Cell Carcinoma	ALIAS	0.90
Adenocarcinoma, Renal	Adenocarcinoma	ONTOLOGY_EXACT	0.85
Kidney Cancer	Malignant Kidney Neoplasm	CURATED_EXACT	0.92
Renal Cell Cancer	Renal Cell Carcinoma	CURATED_BROADER	0.80
Renal Cell Carcinoma	Renal Cell Carcinoma	CURATED_BROADER	0.80

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
NanoDoce
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.
interventionNames
1. Drug: NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension

Primary outcomes (1)

measure
Number of participants with treatment emergent adverse events
timeFrame
Day 1 to 180 days post-last NanoDoce injection
description
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)

Secondary outcomes (1)

measure
Concentration of docetaxel in the systemic circulation post-injection

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.