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

Primary Purpose

Triple Negative Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nanosomal Docetaxel Lipid Suspension (75 mg/m2)
Nanosomal Docetaxel Lipid Suspension (100 mg/m2)
Taxotere® (100 mg/m2)
Sponsored by
Jina Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring Triple Negative Breast Cancer, Docetaxel

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 (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. Patients with life expectancy of at least 6 months.
  11. Serum pregnancy test at screening and urine pregnancy test on Day 1 (before randomization) must be negative.
  12. 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.
  13. Patient with adequate bone marrow, renal and hepatic function.

Exclusion Criteria:

  1. Patient who has a history of hypersensitivity reactions to Docetaxel or any other component of formulation or to any drugs formulated with polysorbate 80.
  2. Patients with a history of HER2 positive over expression and hormone receptor positive (ER or PR)
  3. Patient who is already exposed to Docetaxel injection in metastatic setting.
  4. 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
  5. Uncontrolled diabetes or infection.
  6. Known history of drug addiction within last one year.
  7. Patients with known CNS lesions (brain metastasis or carcinomatous meningitis) except for asymptomatic brain metastases.
  8. 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.
  9. Pre-existing motor or sensory neurotoxicity of a severity greater than or equal to grade two as defined by NCI CTCAE 4.03 criteria.
  10. Known case of HIV infection.
  11. 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.
  12. Patients who are unwilling or unable to follow protocol requirements

Sites / Locations

  • Columbus Regional Research Institute, LLCRecruiting
  • Cox Medical CenterRecruiting
  • Gabrail Cancer CenterRecruiting
  • Kailash Cancer Hospital & Research CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Nanosomal Docetaxel Lipid Suspension - 75 mg/m2

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

R, Taxotere® (100 mg/m2)

Arm Description

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: 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: 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

Outcomes

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

Secondary Outcome Measures

Progression free survival (PFS)
PFS will be evaluated from the date of first dosing to the date of tumor progression (as per the RECIST 1.1 Criteria) or death (due to any cause) whichever occurred first
To evaluate the overall survival (OS) of the patients
OS will be evaluated from the date of first dosing to the date of tumor progression (as per the RECIST 1.1 Criteria) or death (due to any cause) whichever occurred first
Incidence of adverse events as assessed by clinical examination, and/or laboratory parameters
adverse events as assessed by CTCAE v4.0

Full Information

First Posted
August 3, 2018
Last Updated
February 9, 2023
Sponsor
Jina Pharmaceuticals Inc.
Collaborators
Intas Pharmaceuticals, Ltd., Lambda Therapeutic Research Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03671044
Brief Title
A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jina Pharmaceuticals Inc.
Collaborators
Intas Pharmaceuticals, Ltd., Lambda Therapeutic Research Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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 India under the Brand name of DOCEAQUALIP 20/80 (Nanosomal Docetaxel Lipid Suspension for Injection 20/80 mg/vial) since 2013. 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 reference product, Taxotere® at a dose of 100 mg/m2 in triple-negative breast cancer patients with Locally Advanced or Metastatic Breast Cancer. 657 patients (219 patients per arm) will be randomized in the study. To ensure consistent interpretation of measurable disease and objective endpoints for the study, all imaging studies performed throughout the study will be sent to an independent Central Radiological Facility for tumor measurement and evaluation of response. This independent review will have no impact on patient care. Continued participation in the study will be determined by assessment of clinical and radiological response by the Principal Investigator, and/or Radiologist. Efficacy evaluation will be done by CT scan/MRI and Bone scan at the end of treatment cycle 3 and will continue at every 3 cycles while the patient remains on treatment and compared to base line. Patient will continue study treatment until unacceptable toxicity or progression of disease. Patient will be screened up to 14 days prior to dosing and will be dosed on day 1. Patient will be advised to come in the facility at least 02 hours prior to dosing and will remain in the clinical facility until the completion of study drug administration. Dosing of patients will be done on ambulatory basis; hence patient hospitalization is optional. It is the responsibility of the PI to ensure that adequate medical supervision and care is available for the study patients during housing and entire duration of the study for utmost safety and wellbeing of the study patients. All safety analyses will be performed on the Safety set. Safety variables include AEs, clinical laboratory parameters, vital signs, physical examinations and electrocardiogram etc. Safety variables will be listed and summarized with descriptive statistics, as appropriate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer
Keywords
Triple Negative Breast Cancer, Docetaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
657 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nanosomal Docetaxel Lipid Suspension - 75 mg/m2
Arm Type
Experimental
Arm Description
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
Arm Title
T2, Nanosomal Docetaxel Lipid Suspension (100 mg/m2)
Arm Type
Experimental
Arm Description
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
Arm Title
R, Taxotere® (100 mg/m2)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Nanosomal Docetaxel Lipid Suspension (75 mg/m2)
Intervention Description
Each vial containing lyophilized Docetaxel lipid powder, equivalent to 20 mg or 80 mg of anhydrous Docetaxel.
Intervention Type
Drug
Intervention Name(s)
Nanosomal Docetaxel Lipid Suspension (100 mg/m2)
Intervention Description
Each vial containing lyophilized Docetaxel lipid powder, equivalent to 20 mg or 80 mg of anhydrous Docetaxel.
Intervention Type
Drug
Intervention Name(s)
Taxotere® (100 mg/m2)
Intervention Description
Docetaxel Injection Concentrate; 20 mg/0.5 mL
Primary Outcome Measure Information:
Title
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)
Description
Non-inferiority of NDLS (75 mg/m2, 100 mg/m2) compared to Taxotere (100 mg/m2)
Time Frame
Approximately 2 years after study initiation
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
PFS will be evaluated from the date of first dosing to the date of tumor progression (as per the RECIST 1.1 Criteria) or death (due to any cause) whichever occurred first
Time Frame
Approximately 2 years after study initiation
Title
To evaluate the overall survival (OS) of the patients
Description
OS will be evaluated from the date of first dosing to the date of tumor progression (as per the RECIST 1.1 Criteria) or death (due to any cause) whichever occurred first
Time Frame
Approximately 2 years after study initiation
Title
Incidence of adverse events as assessed by clinical examination, and/or laboratory parameters
Description
adverse events as assessed by CTCAE v4.0
Time Frame
Approximately 2 years after study initiation

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mr. Prashant Modi
Phone
+917940202375
Ext
2375
Email
prashantmodi@lambda-cro.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Ravi Alamchandani
Organizational Affiliation
Lambda Therapeutic Research Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Columbus Regional Research Institute, LLC
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Wicker
Phone
706-780-6201
First Name & Middle Initial & Last Name & Degree
Andrew Pippas, MD
Facility Name
Cox Medical Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Young
Phone
417-269-7107
First Name & Middle Initial & Last Name & Degree
Srikant Nannapaneni, MD
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie Smith, RN
Email
csmith@gabrialcancercenter.com
First Name & Middle Initial & Last Name & Degree
Nashat Gabrail, MD
Facility Name
Kailash Cancer Hospital & Research Centre
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
391760
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rakshit Shah
Phone
+919913771374
Email
rakshit.shah@greenashram.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
32547188
Citation
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.
Results Reference
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A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients

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