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NCT03671044 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients
A Phase 3 study of Triple Negative Breast Cancer, sponsored by Jina Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 657
- Enrollment target
- 4
- Study locations
NCT03671044 is a Phase 3 study of Triple Negative Breast Cancer that is actively recruiting participants, run by Jina Pharmaceuticals. The registered enrollment target is 657 participants, above the 241-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (173% higher). The trial reports 4 study locations across 4 states.
The verdict
NCT03671044, a Phase 3 study of Triple Negative Breast Cancer, is actively recruiting participants, sponsored by Jina Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 657 participants
- Enrollment target
- 4
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Nanosomal Docetaxel Lipid Suspension (75 mg/m2)
- DRUG Nanosomal Docetaxel Lipid Suspension (100 mg/m2)
- DRUG Taxotere® (100 mg/m2)
Study Locations (4)
Georgia
- Columbus Regional Research Institute, LLC - Columbus
Missouri
- Cox Medical Center - Springfield
Ohio
- Gabrail Cancer Center - Canton
Gujarat
- Kailash Cancer Hospital & Research Centre - Vadodara
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 657 participants |
| Start Date | 2018-07-10 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03671044
The ClinicalTrials.gov registry entry for NCT03671044 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 657 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 241-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (173% higher). The listed sponsor is Jina Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Nanosomal Docetaxel Lipid Suspension (75 mg/m2) is the first listed.
NCT03671044 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Georgia, Missouri, Ohio.
Frequently Asked Questions
What is clinical trial NCT03671044 about?
NCT03671044 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients". 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 ...
What is the current status of trial NCT03671044?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 657 participants. The study started on 2018-07-10. Estimated completion is 2025-12-31.
What conditions does trial NCT03671044 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer.
What interventions are being tested in trial NCT03671044?
The interventions under investigation include: Nanosomal Docetaxel Lipid Suspension (75 mg/m2) (DRUG), Nanosomal Docetaxel Lipid Suspension (100 mg/m2) (DRUG), Taxotere® (100 mg/m2) (DRUG).
Who is sponsoring clinical trial NCT03671044?
This trial is sponsored by Jina Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03671044 being conducted?
This trial has 4 study locations across Georgia, Missouri, Ohio, Gujarat. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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