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 Panacea Biotec, India with ABRAXANEÂ® (Paclitaxel Protein-bound Particles for Injectable Suspension) (albumin-bound) manufactured for Celgene Corporation, Summit, NJ in Patients with Metastatic Breast Cancer under Fasting Conditions.

PANACEA BIOTEC LIMITED0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Female patients 18 to 70 years of age (both inclusive) having breast cancer who
•a. Has histologically confirmed diagnosis of breast cancer.
•b. Has metastatic breast cancer
•c. Has 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.
•2.Body surface area (BSA) that is within 1.2 to 2.2 m2
•3.Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
•4.Patient has adequate hematological, renal, and hepatic function.

•1.Patients with a history of other malignancies
•2.Patients who have previously received a taxane within the 30 days prior to randomization.
•3.Patients who have not completely recovered from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, or radiotherapies Grade 1 or higher by CTCAE, with the exception of alopecia.
•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 surgery.
•6.Sensory / Peripheral neuropathy of Grade 2 or higher by CTCAE version 4.03 at Screening.
•7.Abnormal ECG : QTc >470 msec in female patients at screening and randomization.
•8.Patients with known brain metastases.

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