CTRI/2021/08/035583进行中（未招募）不适用
A multicenter, open label, randomized, balanced, two treatment, two-sequence, 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 ABRAXANE® 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 India20 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年10月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
- 试验地点
- 20
- 主要终点
- To compare and evaluate the single dose bioavailability of paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial by Cipla Ltd., India with ABRAXANE® for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 100 mg/vial by Celgene Corporation, USA
研究概览
简要总结
This study is being conducted to establish bioequivalence between Cipla product and the comparator product in breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female patients, 18 to 65 years of age (both inclusive) at the time of screening and capable of giving written informed consent prior to receiving any study medication.
- •Meets one of the following criteria: i.
- •Has histological or cytological confirmed metastatic breast cancer after failure of combination chemotherapy for metastatic disease ii.
- •Has had a relapse within 6 months of adjuvant chemotherapy iii.
- •Has histological or cytological confirmed breast cancer who is a candidate for albumin bound paclitaxel therapy in accordance with the standard of care (NCCN guidelines- Breast Cancer) as per PI judgement.
- •Note: In the case of items i and ii above, prior therapy should have included an anthracycline, such as doxorubicin, daunorubicin, mitoxantrone or other related compounds unless clinically contraindicated.
- •3.Patients with life expectancy of at least 6 months as per the investigator’s opinion.
- •4.ECOG performance status of less than equal to
- •Bone marrow function: ANC Greater than equal to 1500cells/mm3 or 1500cells/microlitre, Platelet count Greater than equal to 100,000/mm3, Hemoglobin Greater than equal to 9.0 g/dl Renal function:Serum Creatinine less than 1.5 times ULN, Hepatic function: AST and ALT less than equal to 2.5 times ULN (less than equal to 4 X ULN for liver metastasis) Alkaline phosphatase less than 2 times ULN (less than equal to 5 X ULN for bone metastasis) Bilirubin less than equal to 1.5 times ULN 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 adhere to the protocol requirements.
- •8.Women of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test (UPT) at baseline, must be using an adequate method of contraception and must be willing to avoid getting pregnant during the study period.
- •Female patients must fulfill at least one of the following: 8.1 Be surgically sterile for a minimum of 6 months of study consent date; 8.2 Post-menopausal for a minimum of 1 year of study consent date; 8.3 Agree to avoid pregnancy and use medically acceptable method of contraception from at least 30 days prior to dosing and until 6 months after the study has ended (last study procedure).
- •8.4 Medically acceptable methods of contraception include non-hormonal intrauterine device or double barrier method (condom with foam or vaginal spermicidal suppository, diaphragm with spermicide).
- •Complete abstinence alone can be used as a method of contraception.
排除标准
- •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.
- •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 Pneumonitis), 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 Greater than 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 less than equal to Grade
- •7.A positive HIV, Hepatitis B surface antigen, Hepatitis C, COVID-19 (COVID-19 testing will be handled as per government driven protocol if applicable), drugs of abuse or urine alcohol test.
- •8.Difficulty in fasting or consuming Non-high fat meals.
- •9.Patients who are: 9.1 pregnant 9.2 breast feeding 9.3 of childbearing potential without a negative pregnancy test at baseline 9.4 had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery 10.Known history or presence of: 10.1 Alcohol abuse or dependence within one year prior to first drug administration; 10.2 Drug abuse or dependence; 10.3 Severe allergic reactions (e.g. anaphylactic reactions, angioedema) 11.History of difficulty with donating blood or difficulty in accessibility of veins.
- •12.Any clinically significant abnormal findings in 12 lead ECG, 2D ECHO, X-ray findings, as judged by investigator.
- •13.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) 14.Any other condition, that in the investigator’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.
- •15.Participation in any clinical study, chemotherapy and/ or radiotherapy within the past 30 days of first IP administration or has less than 5 half-lives from previous therapy whichever is longer.
- •16.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
结局指标
主要结局
To compare and evaluate the single dose bioavailability of paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial by Cipla Ltd., India with ABRAXANE® for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 100 mg/vial by Celgene Corporation, USA
时间窗: 96 hours
次要结局
- To monitor the adverse events and to ensure the safety of patients(96 hours)
研究者
研究点 (20)
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