CTRI/2025/07/090966尚未招募不适用
A Randomized, Open-Label, Two Period, Two-Treatment, Two Sequence, Single-Dose, Crossover, Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound), 100 mg/vial of Alembic Pharmaceuticals Ltd, India with ABRAXANE for Injectable Suspension 100 mg/vial of Bristol-Myers Squibb Company, Princeton, NJ 08543 USA in Patients with Metastatic Breast Cancer Under Standard Diet (Non-High-Fat) Conditions.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- To evaluate the bioequivalence of Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound), 100 mg/vial of Alembic Pharmaceuticals Ltd, India with ABRAXANE® for Injectable Suspension 100 mg/vial of Bristol-Myers Squibb Company, Princeton, NJ 08543 USA in Patients with Metastatic Breast Cancer under standard diet (non-high-fat) conditions.
研究概览
简要总结
This study is being conducted to establish bioequivalence between Alembic product and the comparator product in Patients with Metastatic Breast Cancer under standard diet (non-high-fat) conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patient of 18 to 65 years of age (both inclusive).
- •Patient having histological or cytological confirmed breast cancer and who fulfill have the following; a. After failure of combination chemotherapy for metastatic disease OR b. Relapse within 6 months of adjuvant chemotherapy OR c. Patient who is a candidate for albumin bound Paclitaxel therapy in accordance with the standard of care as per PI judgement according to NCCN Guideline. Note: Prior therapy should have included an anthracycline unless clinically contraindicated for 2 a. and 2 b.
- •Body surface area (BSA) that is within 1.2 to 2.2 m2, calculated using the DuBois Formula (Appendix V).
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equals to 2 as per Appendix II.
- •Hematology/chemistry: Patient has adequate hematological, renal, and hepatic function as defined by the following 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) greater than or equals to 1,500 cells/mm3 b. Platelet count greater than or equals to 100,000 cells/mm3 c. Hemoglobin greater than or equals to 9 g/dL d. Creatinine clearance greater than 30 mL per minute (using Cockcroft-Gault formula) Formula of creatinine clearance: Crcl equals to (
- •age) x body weight (Kilogram weight)/plasma creatinine (mg/dl) x 72 x 0.85 (considering female patients). e. Total bilirubin less than or equals to 1.5 mg/dL f. AST (SGOT) less than or equals to 100 U/L g. ALT (SGPT) less than or equals to 100 U/L h. Alkaline phosphatase less than or equals to 300 U/L
- •Patient with Serum albumin greater than or equals to 3.0 gm/dL at screening.
- •Patient with life expectancy of at least 6 months at the time of enrollment.
- •Female with postmenopausal status or female of child-bearing 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. No history of pregnancy in last 30 days prior to randomization. Women who are not postmenopausal greater than or equals to 52 weeks or surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation) are considered of child-bearing potential.
- •Able and willing to adhere to all protocol requirements and study procedures throughout the study.
- •Patient/LAR willing to provide informed consent to participate in the study.
排除标准
- •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 greater than or equals to 5 years.
- •Patient who has previously received a taxane within 30 days prior to randomization.
- •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.
- •The patient receives treatment with any: a.
- •Hormonal therapy within 2 weeks prior to randomization b.
- •Chemotherapy within 4 weeks prior to randomization Note: Except for palliative bisphosphonate therapy for bone pain which can be administered as clinically indicated.
- •Investigational drug or immunotherapy within 4 weeks prior to randomization.
- •Concurrent radiation therapy (except for palliative radiotherapy for bone pain which can be administered as clinically indicated).
- •Patient had major surgery within 30 days prior to randomization, or Patient has not recovered from prior major surgery.
- •Sensory / Peripheral neuropathy of Grade 3 or higher by NCICTCAE Version 5.0 or higher at Screening.
- •Abnormal ECG: QTc greater than 470 msec in patient at screening [QTc interval will be calculated with Bazetts Formula] (Refer Appendix IV).
- •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.
- •Known history or presence of any clinically significant disease or condition other than cancer unless determined as not clinically significant by the Investigator.
- •Known history or presence of Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C.
- •Alcohol or drug abuse or dependence within one year prior to randomization.
- •Hypersensitivity or idiosyncratic reaction to Paclitaxel, its excipients, and/or related substances, including, albumin and PEG.
- •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.
- •Pregnant or lactating female.
- •Patient with presence of uncontrolled hypertension or diabetes mellitus.
- •History of any other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.
- •Use of any strong inhibitor or inducer of CYP2C8 and CYP3A4 in the previous 14 days before randomization.
- •Note: If Patient on stable dosage regimen of moderate OR weak inhibitors/inducers of CYP2C8 and CYP3A4 since at least 1 month before randomization can be allowed; and same stable dosage regimen should be ensured during the study period.
- •Acute active infection requiring treatment within 14 days prior to randomization.
- •Patient has consumed any caffeine, xanthine containing food or beverages (tea, coffee, chocolates or cola drinks), tobacco, tobacco containing products (like pan, pan masala, gutkha), beedi, cigarette, alcohol or recreational drugs within 24 hours prior to randomization.
- •Patient has consumed grapefruit or grapefruit products and pomelo-containing food or fluids within 07 days prior to randomization.
- •Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 90 days prior to randomization.
- •History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture.
- •Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the patients participation in this study.
- •Any other condition that, in the Investigators judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
结局指标
主要结局
To evaluate the bioequivalence of Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound), 100 mg/vial of Alembic Pharmaceuticals Ltd, India with ABRAXANE® for Injectable Suspension 100 mg/vial of Bristol-Myers Squibb Company, Princeton, NJ 08543 USA in Patients with Metastatic Breast Cancer under standard diet (non-high-fat) conditions.
时间窗: 96 hours
次要结局
- To evaluate the safety of study products.(96 hours)
研究者
Dr Dharmesh Domadia
Cliantha Research Limited
研究点 (5)
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