CTRI/2023/11/059593尚未招募Unknown
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) of Qilu Pharmaceutical (Hainan) Co., Ltd., China with ABRAXANE® (Paclitaxel Protein-bound Particles for Injectable Suspension) (albumin-bound) manufactured for Celgene Corporation, Summit, NJ 07901 in Patients with Breast Cancer. - NI
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patient will be eligible for inclusion in this study only if all of the following criteria apply:
- •1. Female patient of 18 to 65 years of age (both inclusive).
- •2. Breast cancer with one of the following:
- •a. Has histological or cytological confirmed metastatic breast cancer after failure of combination chemotherapy for metastatic disease.
- •b. Has had a 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 (NCCN guidelines- Breast Cancer) as per PI judgement.
- •Note: In the case of items a and b above, prior therapy should have included an anthracycline, such as doxorubicin, daunorubicin, mitoxantrone or other related compounds 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 > 60 mL per minute (using Cockcroft-Gault formula)
- •Formula of creatinine clearance: Crcl equals to (140 - age) × body weight (Kilogram weight)/plasma creatinine (mg/dl) × 72 x 0.85 (considering female patients).
- •Total bilirubin = 1.5 x ULN (Upper Limit of Normal)
- •e. AST (SGOT) = 2.5 x ULN
- •f. ALT (SGPT) = 2.5 x ULN
- •g. Serum albumin = 3.0 gm/dL
- •h. Alkaline phosphatase < 2.5 x ULN
- •4. Eastern Cooperative Oncology Group (ECOG) performance status = 2
- •5. All other clinical laboratory parameters and ECG findings 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.
- •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 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 = 52 weeks or surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, bilateral tuballigation) prior to screening 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 to provide written informed consent 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.
排除标准
- •Exclusion Criteria:
- •Patient will not be eligible for inclusion in this study if any of the
- •following criteria apply:
- •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.
- •5. Ongoing or planned lactation during study period.
- •6. Acute active infection requiring treatment from screening till randomization.
- •7. Receipt of other taxane product within the 30 days prior to randomization.
- •8. 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)
- •9. 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.
- •10. Patient with preexisting peripheral neuropathy of NCI toxicity scale >2.
- •11. Major surgery within 30 days prior to randomization, or incomplete recovery from prior major surgery.
- •12. Known history or presence of any clinically significant disease or condition other than cancer unless determined as not clinically significant by the Investigator.
- •13. 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
- •14. Patient with known CNS metastasis.
- •15. 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.
- •16. 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) 14 days before randomization.
- •17. Patient having signs and symptoms suggestive of COVID-19 (such as fever, dry cough, difficulty in breathing and fatigue).
- •18. Consumption of any grapefruit, star fruit
研究者
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