Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Alembic Paclitaxel protein-bound particles for injectable suspension (albumin-bound): Pack size: 100 mg/vial Dose: 260 mg/m2 via IV infusion Single dose
Control Intervention1: Abraxane
Sponsors
Alembic Pharmaceuticals Limited,
Eligibility
Inclusion criteria
Inclusion criteria: . Female patient 18 to 70 years of age (both inclusive) 2. Patient with life expectancy of at least 6 months at the time of enrollment. 3. Patient having breast cancer a) after failure of combination chemotherapy for metastatic disease or b) relapse within 6 months of adjuvant chemotherapy c) has histological or cytological confirmed breast cancer who is a candidate for albumin bound Paclitaxel therapy in accordance with the standard of care as per PI judgement in discussion with the Medical Monitor (NCCN 2021). d) and prior therapy should have included an anthracycline unless clinically contraindicated 4. Body surface area (BSA) that is within 1.2 to 2.2 m2, calculated using the DuBois Formula (Appendix V). 5. Eastern Cooperative Oncology Group (ECOG) performance status = 2 as per Appendix II 6. Hematology/chemistry: Patient has adequate hematological, renal, and hepatic function as defined by the following screening laboratory values obtained within 21 days prior to randomization (patients should not have received a transfusion within 7 days before the screening laboratory assessments): a) Absolute neutrophil count (ANC) = 1,500 cells/mm3 (1.5 x 109/L) b) Platelet count = 100,000 cells/mm3 (100 x 109/L) c) Hemoglobin = 9 g/dL d) Serum creatinine = 1.5 x the upper limit of normal (ULN) e) Total bilirubin = 1.5 x ULN f) AST (SGOT) = 2.5 x ULN (= 5 x ULN in case of liver metastasis) g) ALT (SGPT) = 2.5 x ULN (= 5 x ULN in case of liver metastasis) 7. All other clinical laboratory values deemed normal or not clinically significant judged by the Investigator. 8. Female with postmenopausal status or female of childbearing potential with negative pregnancy test must agree to practice an acceptable method of contraception throughout the study period and for at least 6 months after last dose of study drug. 9. Able and willing to adhere to all protocol requirements and study procedures throughout the study
Exclusion criteria
Exclusion criteria: 1. Patient with a history of other malignancies, except for adequately treated non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, in situ carcinoma of the breast or other solid tumors with no evidence of recurrence for = 5 years. 2. Patient who has previously received a taxane within 30 days prior to randomization. 3. Patient who has not completely recovered from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, or radiotherapies Grade 1 or higher by (National Cancer Institute-Common terminology criteria for Adverse Events) NCI-CTCAE, with the exception of alopecia. 4. Prior chemotherapy must be completed at least 30 days prior to randomization (42 days for mitomycin C or nitrosoureas). Prior immunotherapy, prior antitumor hormonal therapy, and prior radiotherapy must be completed at least 14 days prior to randomization. 5. Patient had major surgery within 30 days prior to randomization, or Patient has not recovered from prior major surgery. 6. Sensory / Peripheral neuropathy of Grade 2 or higher by NCI-CTCAE Version 5.0 or higher at Screening. 7. Abnormal ECG: QTc >470 msec in female patient at screening and randomization [QTc interval will be calculated with Bazett’s Formula] (Refer Appendix IV) 8. Patient with known brain metastases, with the exception of patient who has completed surgery and/or radiotherapy at least 30 days prior to randomization, has completed any steroids as treatment for the metastases at least 30 days prior to randomization, and who is currently asymptomatic. 9. Known history or presence of any clinically significant disease or condition other than cancer unless determined as not clinically significant by the Investigator. 10. History of difficulty with vascular access. 11. Known history or presence of: a) Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C b) Alcohol or drug abuse or dependence within one year prior to randomization c) Hypersensitivity or idiosyncratic reaction to Paclitaxel, its excipients, and/or related substances, including, albumin and PEG. 12. Patient may not participate in any other clinical investigational trial that involves administration of experimental therapy and/or the use of investigational devices with therapeutic intent within 30 days prior to randomization and while enrolled in this study. 13. Pregnant, lactating or breastfeeding female 14. Use of any strong inhibitor or inducer of CYP2C8 and CYP3A4 in the previous 14 days before randomization. 15. Acute active infection requiring treatment within 14 days prior to randomization. 16. Any other condition that, in the Investigator’s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study 17. Patient has consumed any xanthine containing food or beverages (tea, coffee, chocolates or cola drinks), tobacco, tobacco containing products (like pan, pan masala, gutkha), beedi, cigarette within 24 hours prior to each IP administration. 18. Patient has consumed gra
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A study to evaluate the bioequivalence of Paclitaxel Protein bound Particles for Injectable Suspension (albumin-bound), 100 mg/vial of Alembic Pharmaceuticals Ltd, India with Abraxane 5 mg/ml powder for dispersion for infusion of Bristol-Myers Squibb Pharma EEIG, Ireland in Patients with Metastatic Breast Cancer under standard diet (non-high-fat) conditions Timepoint: 96 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of study products.Timepoint: 96 hours | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed