A multicentric, open label, balanced, randomized, two stage, two-treatment, two-period, two-sequence, crossover, multiple oral dose, comparative bioavailability study of cyclophosphamide powder for oral solution (Test drug from Intas pharmaceutical Ltd., India) with Cyclophosphamide Tablets 50 mg (Reference drug from Baxter) in adult patients with breast cancer.

Intas Pharmaceuticals LtdIndia0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月29日

试验速览

阶段: 未知
状态: 已完成
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

•Participants are eligible to be included in the study only if all of the following criteria apply 1.Participant must sign an ICF indicating that she understands the purpose of, and procedures required for the study as described in this protocol and is willing to participate in the study.2.Participant must be female of weight more than or equal to 40 kg, aged between 18 to 55 years of age inclusive, at the time of signing the informed consent.3.Participants with documented medical history of histologically or cytologically confirmed breast cancer. 4.Participant must have of HER2 negative, ER/PR positive or negative breast cancer [as defined by American Society for Clinical Oncology (ASCO)- College of American Pathologists (CAP) guidelines] confirmed by local laboratory performed on primary tumor and/or metastatic lesion.5.Patients who are a. Neoadjuvant, adjuvant, recurrent, or metastatic setting AND b.To be initiated on cyclophosphamide 100 mg/m2(rounded within 5% of the prescribed dose but always in multiples of 50 mg per day) daily for at least 14 days by oral route with established treatment regimen either as a monotherapy or as part of combination therapy as per independent clinical judgement of a treating physician based on standard medical care.OR Already receiving stable dose of cyclophosphamide 100 mg/m2 (rounded within 5% of the prescribed dose in multiples of 50 mg per day) daily for at least 14 days by oral route with established treatment regimen either as a monotherapy or as part of combination therapy as per independent clinical judgement of a treating physician based on standard medical care.6 Documented disease progression (clinical or radiographic imaging) following most-recent anti-cancer systemic study intervention regimen before current cyclophosphamide therapy (not applicable for newly diagnosed patients/adjuvant patients)7.An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 at screening and baseline visit.8.Body mass index (BMI) within the range 18.5 â?? 30 kg/m2 (inclusive) at screening and baseline.9.Life expectancy of more than or equal to 12 weeks at screening and baseline.Patients are required to be in stable health status between the two periods of the study.10.Patient must have recovered from acute toxicity of radiotherapy or previous cycle of chemotherapy before baseline visit. Patients if have received radiotherapy (regardless of site & dose), a gap of 28 days must be maintained between the last dose of radiotherapy and baseline visit.11.A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies•Is not a woman of childbearing potential (WOCBP)OR .Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of more than 1 per year), with low user dependency when used consistently and correctly, during the intervention period and for at least 12 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for a period of at least 12 months. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.•A WOCBP must have a negative highly sensitive serum pregnancy test at screening; and urine pregnancy test before the first dose of study intervention at baseline visit.• If a urine test cannot be confirmed as negat

排除标准

•Any potential participant who meets any of the following criteria will be excluded from participating in the study
•1.History of clinically significant medical condition including but not limited to liver insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances any severe, acute, or chronic medical, psychiatric or social condition or laboratory abnormality that as per Investigator opinion may either a). not be in the best interest of the participant e.g compromise the well-being, b). interfere with the informed consent process and or with compliance with the requirements of the trial, or c). prevent, limit, or confound the protocol-specified assessments or d). result in the variation of absorption or metabolism of drug, i.e ulcerative colitis, or gastrointestinal disease.
•2.Known allergies, hypersensitivity, or intolerance to cyclophosphamide powder or tablet or its excipients
•3.Contraindications to the use of cyclophosphamide per SmPC at screening and at baseline.
•Participant with bladder urinary toxicity of cyclophosphamide
•Participant with urinary outflow obstructions or acute urothelial toxicity from cytotoxic chemotherapy or radiation therapy
•Participant with severe infection within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia OR Received oral or IV antibiotics within 2 weeks prior to Baseline visit. Patients receiving routine antibiotic prophylaxis e.g to prevent chronic obstructive pulmonary disease exacerbation or for dental extraction are eligible.
•Participant who have history of hypersensitivity to study drug formulation, alone or as part of combination chemotherapy or any sensitivity to alkylating agents.
•4.Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant, (e.g compromise the well-being)or that could prevent, limit, or confound the protocol specified assessments
•5 Had of major surgery,(e.g requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 30 days after the last dose of study intervention administration.
•NOTE Participants with planned surgical procedures to be conducted under local anesthesia may participate
•6.History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening Visit.
•7.History of human immunodeficiency virus HIV antibody positive, or tests positive for HIV at Screening Visit.
•8.History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders 5th edition DSM criteria within 1 year before Screening or positive test result for alcohol or drugs of abuse including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines at Screening Visit.
•9.Lymphoma, leukemia, or any malignancy within the past 5 years except for malignancy under study, basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years;carcinoma in situ of the cer

研究者

发起方

Intas Pharmaceuticals LtdIndia

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Comparative pharmacokinetics study (study to know the amount of study drug (cyclophosphamide) in your blood at specified time points – to understand what body does to this study drug) of two products of cyclophosphamide powder for oral solution and Cyclophosphamide Tablets 50 mg in adult patients with breast cancerAdult female patients with breast cancer.MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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