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

NCT03671044 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 0063-17
• Study Type: interventional
• Target: 657
• Locations: 2 countries
• Sites: 4

Brief 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

Triple Negative Breast Cancer

Keywords

Triple Negative Breast Cancer; Docetaxel

Outcome Measures

Primary Outcomes (1)

• 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)

  Non-inferiority of NDLS (75 mg/m2, 100 mg/m2) compared to Taxotere (100 mg/m2)

  Approximately 2 years after study initiation

Secondary Outcomes (3)

• Progression free survival (PFS)

  Approximately 2 years after study initiation

• To evaluate the overall survival (OS) of the patients

  Approximately 2 years after study initiation

• Incidence of adverse events as assessed by clinical examination, and/or laboratory parameters

  Approximately 2 years after study initiation

Study Arms (3)

Nanosomal Docetaxel Lipid Suspension - 75 mg/m2

EXPERIMENTAL

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

Drug: Nanosomal Docetaxel Lipid Suspension (75 mg/m2)

T2, Nanosomal Docetaxel Lipid Suspension (100 mg/m2)

EXPERIMENTAL

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

Drug: Nanosomal Docetaxel Lipid Suspension (100 mg/m2)

R, Taxotere® (100 mg/m2)

ACTIVE COMPARATOR

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

Drug: Taxotere® (100 mg/m2)

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 - 75 mg/m2

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.

T2, Nanosomal Docetaxel Lipid Suspension (100 mg/m2)

Taxotere® (100 mg/m2) DRUG

Docetaxel Injection Concentrate; 20 mg/0.5 mL

R, Taxotere® (100 mg/m2)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient willing to give written signed and dated informed consent to participate in the study.
• Patient must have histopathologically or cytologically confirmed triple negative breast cancer.
• Patients may have received one prior chemotherapy regimen for adjuvant therapy and/or one chemotherapy treatment/regimen for firstline metastatic therapy
• Patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.
• Have at least one measurable lesion as per the RECIST criteria (version 1.1).
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to two
• Left Ventricular Ejection fraction (LVEF) greater than or equal to 50 percentage as per Echocardiography (ECHO).
• Patient must have recovered from any toxic effects of previous chemotherapy or radiotherapy as judged by the Investigator.
• Previous chemotherapy or radiotherapy should be completed 4 weeks prior to start of IMP administration.
• Patients with life expectancy of at least 6 months.
• Serum pregnancy test at screening and urine pregnancy test on Day 1 (before randomization) must be negative.
• Sexually active women, unless surgically sterile or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives \[any hormonal method in conjunction with a secondary method\], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile \[at least 6 months prior to Study drug administration\] sexual partner) for at least four weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
• Patient with adequate bone marrow, renal and hepatic function.

You may not qualify if:

• Patient who has a history of hypersensitivity reactions to Docetaxel or any other component of formulation or to any drugs formulated with polysorbate 80.
• Patients with a history of HER2 positive over expression and hormone receptor positive (ER or PR)
• Patient who is already exposed to Docetaxel injection in metastatic setting.
• Any of the cardiac conditions like Unstable angina, Myocardial infarction within the past six months, Severe uncontrolled ventricular arrhythmias, Clinically significant pericardial disease, Electrocardiographic evidence of acute ischemia, Patient with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) except in whom the disease has been stable for the past six months, History of cardiac disease that met the NYHA Classification class 2 or greater
• Uncontrolled diabetes or infection.
• Known history of drug addiction within last one year.
• Patients with known CNS lesions (brain metastasis or carcinomatous meningitis) except for asymptomatic brain metastases.
• The receipt of an investigational medicinal product or participation in other drug research study within a period of 30 days prior to the first dose of investigational medicinal Product for the current study.
• Pre-existing motor or sensory neurotoxicity of a severity greater than or equal to grade two as defined by NCI CTCAE 4.03 criteria.
• Known case of HIV infection.
• Any other condition that, in the investigator's judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
• Patients who are unwilling or unable to follow protocol requirements

Sponsors & Collaborators

• Jina Pharmaceuticals Inc.: lead
• Intas Pharmaceuticals, Ltd.: collaborator
• Lambda Therapeutic Research Ltd.: collaborator

Study Sites (4)

Columbus Regional Research Institute, LLC

Columbus, Georgia, 31904, United States

RECRUITING

Cox Medical Center

Springfield, Missouri, 65807, United States

RECRUITING

Gabrail Cancer Center

Canton, Ohio, 44718, United States

RECRUITING

Kailash Cancer Hospital & Research Centre

Vadodara, Gujarat, 391760, India

RECRUITING

Related Publications (1)

• Subramanian S, Prasanna R, Biswas G, Das Majumdar SK, Joshi N, Bunger D, Khan MA, Ahmad I. Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Breast Cancer: Results from a Multicenter Retrospective Study. Breast Cancer (Dove Med Press). 2020 May 22;12:77-85. doi: 10.2147/BCTT.S236108. eCollection 2020.

  PMID: 32547188 DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Dr. Ravi Alamchandani

  Lambda Therapeutic Research Ltd.

  STUDY CHAIR

Central Study Contacts

Mr. Prashant Modi

CONTACT

+917940202375; prashantmodi@lambda-cro.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Experimental: T1, 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.

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: September 14, 2018
• Study Start: July 10, 2018
• Primary Completion: May 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

US (3); IN (1)