CTRI/2014/10/005128尚未招募未知
A MULTICENTER OPEN LABEL, BALANCED, RANDOMIZED, TWO-TREATMENT, TWO-PERIOD, TWO-SEQUENCE, SINGLE-DOSE, CROSSOVER BIOEQUIVALENCE STUDY OF PACLIALL(PACLITAXEL PROTEIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION MANUFACTURED BY PANACEA BIOTEC LTD., INDIA) WITH ABRAXANE® (PACLITAXEL PROTEIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION MANUFACTURED FOR CELGENE CORPORATION,USA) IN BREAST CANCER PATIENTS - PacliAll
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1.Female, non-pregnant and non-lactating patients between 18 and 65 years of age (both inclusive). If patient is of child bearing potential, as evident by regular menstrual periods, she must have a negative serum pregnancy test at screening and negative urine pregnancy test on the day of admission of each period and if sexually active should agree to utilize contraception considered adequate and appropriate by the investigator.
- •2.Histologically or cytologically confirmed breast cancer
- •3.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.ER/PR â??ve or ER/PR status unknown (defined as no histo-pathological evidence for confirmation of ER/PR status).
- •5.Patient has no other malignancy within the past 5 years except non-melanoma skin cancer, cervical intraepithelial neoplasia [CIN], or in situ cervical cancer [CIS].
- •6.Eastern Cooperative Oncology Group (ECOG)3 performance status of 0, 1 or 2 (refer annexure III)
- •7.Patiens who are suitable candidates for single agent paclitaxel treatment
- •8.Hematology levels at baseline of:
- •(i)ANC >= 1.5 Ã? 109/L (1,500 cells/mm3)
- •(ii)Platelets >= 100 Ã? 109/L (100,000 cells/mm3)
- •(iii)Hb >= 100 g/L (10 g/dL)
- •9.Adequate organ function at baseline as defined by:
- •(i)AST (SGOT), ALT (SGPT) <= 1.5 Ã? upper limit of normal range (ULN)
- •(ii)Total bilirubin within normal range
- •(iii)Creatiine within normal range
- •(iv)Alkaline phosphatase <= 5 ï?´ ULN
- •10.Expected survival of > 12 week
- •11.Patient is available for and able to comply with the study-specific blood sampling requirements for pharmacokinetic evaluations.
- •12.Patient must have recovered from all toxicities of prior treatments to NCI-CTCAE v4.0 <=Grade 1 before administration of study drug
排除标准
- 未提供
研究者
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