Effect of paclitaxel protein-bound particles for injectable suspension in breast cancer patients.
- Conditions
- Health Condition 1: C50- Malignant neoplasm of breast
- Registration Number
- CTRI/2024/04/065727
- Lead Sponsor
- Dr Reddys Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Female patient of 18 to 65 years of age (both inclusive). 2. Breast cancer with both of the following: a. Histologically or cytologically confirmed diagnosis b. Failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy (Prior therapy should have included an anthracycline unless clinically contraindicated). 3. Adequate hematological, renal, and hepatic function as defined by the following screening laboratory values obtained at screening and 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 (1.5x109 /L) b. Platelet count = 100,000 cells/mm3 (100x109 /L) c. Hemoglobin = 9 g/dL d. Creatinine clearance more than 30 mL per minute minute (using Cockcroft Gault formula) Formula of creatinine clearance: Crcl equals to (140 - age) x body weight (Kilogram weight)/plasma creatinine (mg/dl) x 72 x 0.85 (considering female patients). e. Total bilirubin = 1.5 mg/dL, AST (SGOT) = 100 U/L, ALT (SGPT) = 100 U/L, Serum albumin = 3.0 gm/dL, Alkaline phosphatase = 300 U/L. 4. Eastern Cooperative Oncology Group (ECOG) performance status = 2 (Appendix II). 5. All other clinical laboratory values deemed normal or not clinically significant judged by the Investigator. 6. Body surface area (BSA) that is within 1.2 to 2.2 m2 , calculated using the Du Bois Formula (Appendix III). 7. Patient with life expectancy of at least 3 months at the time of enrollment. 8. Female patient with postmenopausal status or female patient of childbearing potential with negative pregnancy test [negative serum pregnancy test (ß-hCG) at screening, and negative urine pregnancy test prior to each dose of study drug] must agree to practice a medically acceptable method of contraception throughout the study period and for at least 6 months after last dose of study drug. No history of pregnancy in last 30 day prior to randomization. Women who are not postmenopausal = 52 weeks or surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation) are considered of child-bearing potential. 9. Patient who had taken COVID-19 vaccine, must have recovered from vaccine related adverse events before being screened for the study. 10. Patient willing and able to adhere to all protocol requirements and study procedures throughout the study. 11. Ability to comprehend and be informed of the nature of the study, as assessed by study clinic staff
1. History of allergy or hypersensitivity reactions to a paclitaxel or the components of paclitaxel protein-bound particles for injectable suspension (albumin-bound) including, albumin and PEG or any related compound at any dose. 2. Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal (e.g., intra-abdominal inflammation), cardiovascular (e.g., congestive heart failure, ventricular arrhythmia, myocardial infarction, unstable angina pectoris), cerebrovascular, pulmonary (e.g., interstitial lung disease), endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological (e.g., bleeding diathesis or coagulopathy) disease or condition other than breast cancer unless determined as not clinically significant by the Investigator. 3. Patient with presence of uncontrolled hypertension or diabetes mellitus. 4. History of any other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer. 5. Ongoing or planned lactation during study period. 6. Receipt of a taxane within the 30 days prior to randomization. 7. The patient receives treatment with any: a. Hormonal therapy 2 weeks prior to first dose b. Chemotherapy (except for palliative bisphosphonate therapy for bone pain which can be administered as clinically indicated) 4 weeks prior to first dose c. Investigational drug or immunotherapy within 4 weeks prior to first dose d. Concurrent radiation therapy (except for palliative radiotherapy for bone pain which can be administered as clinically indicated) 8. Incomplete recovery from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, or radiotherapies Grade 1 or higher by current version of CTCAE, with the exception of alopecia. 9. Patient with preexisting peripheral neuropathy of NCI toxicity scale greater than 2. 10. Major surgery within 30 days prior to randomization, or incomplete recovery from prior major surgery. 11. Known history or presence of any clinically significant disease or condition other than cancer unless determined as not clinically significant by the Investigator. 12. Known history or presence of: a. Infection with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C b. Alcohol or drug abuse or dependence within one year prior to randomization 13. Patient with known CNS metastasis. 14. Participation in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or the use of investigational devices with therapeutic intent within 30 days or period equivalent of 5 half-lives of the investigational intervention prior to randomization and while enrolled in this study. 15. Receipt of any known CYP2C8 and CYP3A4 inhibitor (e.g., ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) or inducer (e.g., rifampicin, carbamazepine, phenytoin, efavirenz, and nevirapine) in the previous 14 days before randomization. 16. Patient having signs and symptoms suggestive of COVID-19 (such as fever, dry cough, difficulty in breathing and fatigue). 17. Consumption of any grapefruit, star fruit, grape fruit juice, seville oranges, and seville orange juice and its products within 07 days prior to randomization. 18. Ingestion of any alcoholic food (e.g. plum pudding, cake, chocolate containing alcohol) or beverage containing alcohol or utilize recreational d
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, AUC0-t and AUC0-infTimepoint: Considering the minimum washout period, expected study duration of clinical part is 9 week from the day of screening <br/ ><br>
- Secondary Outcome Measures
Name Time Method Tmax, t1/2, Kel, AUC%Extrap_obs, Vd and ClTimepoint: Considering the minimum washout period, expected study duration of clinical part is 9 week from the day of screening <br/ ><br>