A Global, Multicenter, Three Arms, Open-label Randomized Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension Compared to Taxotere® (Docetaxel Injection Concentrate) in Triple-negative Breast Cancer Patients With Locally Advanced or Metastatic Breast Cancer After Failure to Prior Chemotherapy
Jina Pharmaceuticals Inc.
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.
Description
Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semi synthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. It acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. The Nanosomal Docetaxel Lipid Suspension (NDLS) consists of uniformly sized micro particles of docetaxel suspended in a lipid based formulation. Docetaxel Lipid Suspension for Injection 20 mg/80 mg was approved for marketing in India. Intas Pharmaceuticals Ltd., is marketing this drug in In…
Eligibility
- Age range
- 18–65 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. 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 (EC…
Interventions
- DrugNanosomal Docetaxel Lipid Suspension (75 mg/m2)
Each vial containing lyophilized Docetaxel lipid powder, equivalent to 20 mg or 80 mg of anhydrous Docetaxel.
- DrugNanosomal Docetaxel Lipid Suspension (100 mg/m2)
Each vial containing lyophilized Docetaxel lipid powder, equivalent to 20 mg or 80 mg of anhydrous Docetaxel.
- DrugTaxotere® (100 mg/m2)
Docetaxel Injection Concentrate; 20 mg/0.5 mL
Locations (4)
- Columbus Regional Research Institute, LLCColumbus, Georgia
- Cox Medical CenterSpringfield, Missouri
- Gabrail Cancer CenterCanton, Ohio
- Kailash Cancer Hospital & Research CentreVadodara, Gujarat