A multicenter, open label, randomized, two treatment, four period, replicate crossover, single dose, bioequivalence study of paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial by Cipla Ltd., India with ABRAXANEÂ® for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 100 mg/vial by Celgene Corporation, USA in breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

Cipla Ltd India0 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

阶段: 未知
状态: 暂停
发起方

研究概览入排标准研究者记录与标识符相似试验

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. Patients who are capable of giving written informed consent prior to receiving any study medication.
•2. Has histological or cytological confirmed metastatic breast cancer after failure of combination chemotherapy for metastatic disease or has had a relapse within 6 months of adjuvant chemotherapy (Prior therapy should have included an anthracycline unless clinically contraindicated.).
•3. Patients with life expectancy of at least 3 months as per the investigators opinion.
•4. ECOG performance status of <= 2.
•5. Acceptable hemopoeitic, renal and liver function.
•6. All other clinical laboratory values deemed as not clinically significant by the principal investigator/sub-investigator.
•7. Availability for the entire study duration and willingness to comply/adhere to the protocol requirements.
•8. Women of childbearing potential must have a negative serum pregnancy test, must be using an adequate method of contraception and must be willing to avoid getting pregnant during the study.

排除标准

•1. History of allergy or hypersensitivity reactions to a paclitaxel or the components of paclitaxel protein-bound particles for injectable suspension (albumin-bound) 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 cancer unless determined as not clinically significant by the investigator.
•3. History of any other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.
•4. Sensory peripheral neuropathy of > Grade 2 at baseline.
•5. Presence of any significant physical or organ abnormality or active opportunistic infection (i.e. mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis jiroveci) as determined by the Investigator.
•6. Patients not completely recovered from any toxicities from previous chemo-, hormone-, immuno-, or radiotherapies <=Grade 1.
•7. A positive HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse or breath alcohol test.
•8. Difficulty in fasting or consuming standard meals.
•9. History of difficulty with donating blood or difficulty in accessibility of veins.
•10. Any clinically significant abnormal findings in 12 lead ECG, 2D ECHO, X-ray findings, as judged by investigator.
•11. Patient is taking inhibitor, or inducer of CYP2C8 or CYP3A4 enzymes and in whom these drugs are unable to be restricted for the entire study period. (Annexure IV)
•12. Any other condition, that in the investigatorâ??s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
•13. Patients who have not recovered from the side effects of previous therapy.

研究者

发起方

Cipla Ltd India

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