A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients

Part of paid clinical trials in Columbus, Georgia.

Sponsor
Jina Pharmaceuticals Inc.
Study ID
NCT03671044
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Nanosomal Docetaxel Lipid Suspension (75 mg/m2) — DRUG
    Each vial containing lyophilized Docetaxel lipid powder, equivalent to 20 mg or 80 mg of anhydrous Docetaxel.
  • Nanosomal Docetaxel Lipid Suspension (100 mg/m2) — DRUG
    Each vial containing lyophilized Docetaxel lipid powder, equivalent to 20 mg or 80 mg of anhydrous Docetaxel.
  • Taxotere® (100 mg/m2) — DRUG
    Docetaxel Injection Concentrate; 20 mg/0.5 mL

Study Details

The Nanosomal Docetaxel Lipid Suspension (NDLS) consists of uniformly sized micro particles of docetaxel suspended in a lipid based formulation. The advantage of such a Lipid Based formulation of Docetaxel is an improvement of the safety profile by eliminating excipients, polysorbate 80 and ethanol which are present in conventional Docetaxel formulations (Taxotere®). This randomized, open-label study is designed to assess the efficacy and safety of Nanosomal Docetaxel Lipid Suspension at the dose of 75 mg/m2 and at the dose of 100 mg/m2 compared to Taxotere® at the dose of 100 mg/m2 in triple-negative breast cancer patients with Locally Advanced or Metastatic Breast Cancer. Patients will continue the treatment in the absence of disease progression and unacceptable toxicity. Disease status and tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines. 657 patients (219 patients per arm) will be randomized in the study. The trial will be conducted as per the ICH GCP Guidelines E6 (R1), Schedule Y (Amended Version 2013), Declaration of Helsinki (Fortaleza, Brazil, October 2013), ICMR Guidelines for Biomedical Research on Human subjects and in accordance with other applicable guidelines.

Key Dates

Start date
Jul 10, 2018
Status verified
Mar 2025
Primary completion
May 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
657 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nanosomal Docetaxel Lipid Suspension - 75 mg/m2
    Experimental: NDLS for Injection, 75 mg/ m2 Nanosomal Docetaxel Lipid Suspension for Injection; Dose: 75 mg/m2; Frequency: Every 3-weeks; Duration of treatment: Patient will be dosed with drug until disease progression and/or unacceptable toxicity
  • Experimental: T2, Nanosomal Docetaxel Lipid Suspension (100 mg/m2)
    Experimental: NDLS for Injection, 100 mg/ m2 Nanosomal Docetaxel Lipid Suspension for Injection; Dose: 100 mg/m2; Frequency: Every 3-weeks; Duration of treatment: Patient will be dosed with drug until disease progression and/or unacceptable toxicity
  • Active Comparator: R, Taxotere® (100 mg/m2)
    Active Comparator: Taxotere® Injection Concentrate Docetaxel Injection Concentrate; Dose: 100 mg/m2; Frequency: Every 3-weeks; Duration of treatment: Patient will be dosed with drug until disease progression and/or unacceptable toxicity

Primary Outcome Measure

Proportion of the patients with Objective Response Rate (i.e., CR + PR) as the Best Overall Response Rate (i.e., CR + PR) in the test arm (NDLS) compared to reference arm (Taxotere) [ Time Frame: Approximately 2 years after study initiation ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Columbus Regional Research Institute, LLCColumbusGeorgia31904
Heather Wicker
706-780-6201
Andrew Pippas, MD (PRINCIPAL_INVESTIGATOR)
Cox Medical CenterSpringfieldMissouri65807
Anna Young
(417) 269-7107
Srikant Nannapaneni, MD (PRINCIPAL_INVESTIGATOR)
Gabrail Cancer CenterCantonOhio44718
Carrie Smith, RN
[email protected]
Nashat Gabrail, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbus, GA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Columbus Regional Research Institute, LLC· Columbus, GACox Medical Center· Springfield, MOGabrail Cancer Center· Canton, OH

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