NCT03671044 · Jina Pharmaceuticals Inc.
A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients
What this study is about
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®).
View original scientific description
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®).
Interventions
DRUG
Nanosomal Docetaxel Lipid Suspension (75 mg/m2)
Each vial containing lyophilized Docetaxel lipid powder, equivalent to 20 mg or 80 mg of anhydrous Docetaxel.
DRUG
Nanosomal Docetaxel Lipid Suspension (100 mg/m2)
Each vial containing lyophilized Docetaxel lipid powder, equivalent to 20 mg or 80 mg of anhydrous Docetaxel.
DRUG
Taxotere® (100 mg/m2)
Docetaxel Injection Concentrate; 20 mg/0.5 mL
Primary outcome measures
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
Non-inferiority of NDLS (75 mg/m2, 100 mg/m2) compared to Taxotere (100 mg/m2)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- The patient willing to give written signed and dated informed consent to participate in the study. 2. Patient must have histopathologically or cytologically confirmed triple negative breast cancer. 3. Patients may have received one prior chemotherapy regimen for adjuvant therapy and/or one chemotherapy treatment/regimen for firstline metastatic therapy 4. Patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. 5. Have at least one measurable lesion as per the RECIST criteria (version 1.1). 6. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to two 7. Left Ventricular Ejection fraction (LVEF) greater than or equal to 50 percentage as per Echocardiography (ECHO). 8. Patient must have recovered from any toxic effects of previous chemotherapy or radiotherapy as judged by the Investigator. 9. Previous chemotherapy or radiotherapy should be completed 4 weeks prior to start of IMP administration. 10
Where
- Columbus, Georgia
- Springfield, Missouri
- Canton, Ohio
Collaborators
Intas Pharmaceuticals, Ltd., Lambda Therapeutic Research Ltd.
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 21, 2025 · Source of record for eligibility and locations