CTRI/2022/12/048030尚未招募未知
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 AlembicPharmaceuticals 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
Alembic Pharmaceuticals Limited,0 个研究点目标入组 0 人开始时间: 待定最近更新:
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- 状态
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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
- •. 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
- •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
- •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
排除标准
- •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
- •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
- •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
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