CTRI/2022/07/043652已完成未知
A Randomized, Multi-Center, Open-Label, Single-Dose, Two-Way Crossover Study to Assess Bioequivalence of Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) of Intas Pharmaceuticals Limited, India Compared with Abraxane® in Female Participants with Advanced Breast Cancer
Intas Pharmaceuticals Ltd India0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
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研究概览
简要总结
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研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:1 Able to sign an ICF indicating that the participant understands the purpose of, and procedures required for the study in this protocol and is willing to participate in the study.2 Woman participant must be greater than or equal to 18 years of age at the time of signing the informed consent.3.Participant with breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated, 4 Participant has a life expectancy of at least 3 months. 5 Participant has an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. 6 A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of less than 1% per year), preferably with low user dependency when used consistently and correctly, during the intervention period and for at least 6 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for a period of 6 months. The investigator should evaluate the effectiveness and the potential for contraceptive method failure (e.g., noncompliance, recently initiated) of the contraceptive method in relationship to the first dose of study intervention. • A WOCBP must have a negative highly sensitive pregnancy test (serum) at screening visit and within 24 hours before the first dose of study intervention (urine). • If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. • Additional requirements for pregnancy testing during and after study intervention.7 Participant with hematologic, liver and renal function as following: a) ANC greater than or equal to 1500 per mm3 at screening visit; and prior to dosing in each period. b) Platelet count greater than or equal to 100,000 per mm3 at screening; and prior to dosing in each period. c) Hemoglobin greater than or equal to 9.0 g per dL at screening visit. d) Estimated glomerular filtration rate of greater than or equal to 30 mL per min per sq.m by CKD Epidemiology Collaboration (CKD-EPI) creatinine equation at screening visit. e) Aspartate transaminase (AST) less than or equal to 10 Ã? upper limit of normal (ULN) AND Total bilirubin less than or equal to 1.5 Ã? ULN at screening visit; and prior to dosing in each period. 8 Participant should have recovered from the toxicity or adverse effects of previous radiation, surgery and/or chemotherapy as per investigatorâ??s assessment before administration of study intervention. In case of irreversible toxicity, it should be clinically stable.
排除标准
- •Any potential participant who meets any of the following criteria will be excluded from participating in the study:
- •1 Documented medical history of clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- •2 Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components (paclitaxel or other taxanes) or excipients thereof (refer to the prescribing information of Abraxane) that, in the opinion of the investigator, are severe in intensity which contraindicates the use of study intervention.
- •3 Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of investigational intervention.
- •4 Positive hepatitis C antibody test result at screening or within 3 months prior to starting investigational intervention. NOTE, Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained.
- •5 Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody test at screening.
- •6 Presence of sensory neuropathy with severity greater than or equal to grade 2 by NCI-CTCAE v5.0 criteria based on clinical judgement.
- •7 Presence of an active infection requiring treatment with systemic antibiotics prior to the first dose of study medication.
- •8 Participant has received doses of any moderate or strong CYP2C8 or CYP3A4 inhibitor or inducer within 14 days prior to the first dose of study medication.
- •9 History of malignancy (except breast cancer) within the past 3 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years; carcinoma in situ of the cervix; or malignancy, which is considered cured with minimal risk of recurrence.
- •10 Current or chronic history of liver disease or known hepatic or biliary abnormalities. This includes but is not limited to active hepatitis virus infections, drug- or alcohol-related liver disease, non-alcoholic steatohepatitis, autoimmune hepatitis, hemochromatosis, Wilsons disease, alpha-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease considered clinically significant by the investigator with the exception of Gilberts syndrome or asymptomatic gallstones.
- •11 Participant with known history or current symptoms of any of the following clinically significant cardiac conditions: (a) Unstable angina or myocardial infarction within the past 6 months prior to Screening visit (b) Symptomatic congestive heart failure (CHF) (New York Heart Association (NYHA) functional classification for cardiac disease of Class II at Screening visit (c) Serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality at screening visit. (d) Electrocardiographic evidence of acute ischemic or active conduction system abnormalities at screening assessment. (e) Left ventricular ejection fraction (LVEF) less than 50 percent as measured by 2D ECHO at Screening.
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