CTRI/2025/02/079937已完成不适用
A multicenter, open label, randomized, balanced, two treatment, two sequence, two period, crossover, single dose, bioequivalence study of Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial of Hetero Labs Limited, India with ABRAXANE® for injectable suspension (Paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 100 mg/vial by Celgene Corporation Summit, NJ 07901 in metastatic breast cancer patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- To characterize the pharmacokinetic profiles of Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial (test product) to ABRAXANE® for injectable suspension (Paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 100 mg/vial (reference product) in breast cancer patients.
研究概览
简要总结
This study is a multicenter, open label, randomized, balanced, two treatment, two sequence, two period, crossover, single dose, bioequivalence study in breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
Treatments will be allocated to the patients as per the SAS generated randomization sequence (i.e. T-R or R-T). The Test (T) or Reference (R) products will be administered as a 30-minute (±2minutes window period) intravenous infusion on Day 1 of each treatment period per two Consecutive Cycles (i.e., Administration of the Investigational products will be done on Day 1 of each 21-day cycle).
During each treatment period, serial blood samples will be collected at pre-determined time-points. Patients will remain in the clinical research until 96 hours post-dose. Pharmacokinetic samples will be collected up to 96 hours after the start of the infusion. Sensory peripheral neuropathy as per the standard practice at each study visit. Plasma concentration of drug i.e. unbound and total paclitaxel will be quantified by using validated analytical method. Statistical analysis of pharmacokinetic parameters of test and reference formulations will be performed to assess bioequivalence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
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.
- •2.Meets one of the following criteria: a)Has histological or cytological confirmed metastatic breast cancer after failure of combination chemotherapy for metastatic disease.
- •OR b)Has had a relapse within 6 months of adjuvant chemotherapy.
- •OR c)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 a and b 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 investigators opinion.
- •4.ECOG performance status of less than or equal
- •5.Acceptable hemopoietic, renal and liver function( Bone marrow function: ANC greater than or equal 1500 cells per mm3 or 1500 cells per microliter, Platelet count greater than or equal 100,000per mm3, Hemoglobin greater than or equal 9.0g per dl.
- •Renal function: Serum Creatinine less than 1.5 times ULN, Hepatic function: AST and ALT less than 2.5 times ULN (less than 4 X ULN for liver metastasis), Alkaline phosphatase less than2 times ULN (5 X ULN for bone metastasis), Bilirubin less than 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 comply/adhere to the protocol requirements.
- •8.Female patients must fulfil at least one of the following: Be surgically sterile for a minimum of 6 months, Post-menopausal for a minimum of 1 year of study consent date; 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).
- •Medically acceptable methods of contraception include nonhormonal 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
- •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.History of any other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.
- •3.Sensory peripheral neuropathy of greater than Grade 2 at baseline.
- •4.Presence of any significant physical or organ abnormality or active opportunistic infection (mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis jiroveci) as determined by the Investigator.
- •5.Patients not completely recovered from any toxicities from previous chemo, hormone, immuno, or radiotherapies Grade
- •6.Patients who are, Pregnant or breast feeding, pr of childbearing potential without a negative pregnancy test at baseline had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery.
- •7.Known history or presence of Alcohol abuse or dependence within one year prior to first drug administration or Drug abuse or dependence or severe allergic reactions (e.g. anaphylactic reactions, angioedema) or History of difficulty with donating blood or difficulty in accessibility of veins.
- •8.Any clinically significant abnormal findings in 12 lead ECG, 2D ECHO, X ray findings, as judged by investigator.
- •9.Any other condition, that in the investigators judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
- •10.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.
- •11.Any chemotherapy, targeted therapy, major surgery, or irradiation must have been completed at least 4 weeks before enrolment (6 weeks for mitomycin C or nitrosurea).
- •Additional requirements include, Immune therapy or hormonal therapy (except palliative bisphosphonate therapy for bone pain) must be completed 2 weeks before enrolment, patients must have recovered from all toxicities resulting from previous therapy, except for alopecia, Use of targeted therapy or antibody therapy should have been completed for at least 5 half lives of the respective therapy before enrolment, Narcotic analgesics, such as dihydrocodeine, must have been discontinued at least 2 weeks before enrolment, Medicinal herbs, such as St. Johns Wort (which may act as inhibitors or inducers of CYP2C8 and CYP3A4), must have been discontinued at least 4 weeks before enrolment.
- •12.Presence of pleural or ascitic fluid which cannot be definitively treated prior to dosing and during the PK blood draws in each period (Period 1 and Period 2) and if there is re accumulation of fluid (greater than 5 percent ) greater than 2 weeks after definitive management.
- •13.Positive laboratory exclusion test (HIV, HBsAg, or HCV) 14.Treatment with investigational agents or participation in a clinical trial within 30 days of study entry.
- •15.Failure of prior taxane therapy for metastatic disease or for adjuvant therapy within previous 6 months of screening visit 16.Serious non-healing wound, ulcer or bone fracture 17.History of gastrointestinal perforation within 6 months prior to screening visit.
结局指标
主要结局
To characterize the pharmacokinetic profiles of Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial (test product) to ABRAXANE® for injectable suspension (Paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 100 mg/vial (reference product) in breast cancer patients.
时间窗: Pharmacokinetic blood sample time points will be collected at 0.00 and 0.16, 0.33, 0.50, 0.66, 0.83, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 6.00, 8.00, 12.00, 20.00, 24.00, 36.00, 48.00, 72.00, and 96.00 hours.
次要结局
- Assess the safety & tolerability(At baseline, 3 weeks & 6 weeks)
研究者
Dr Raju Lingumpelly
Clians Labs Private Limited
研究点 (5)
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