CTRI/2021/06/034321已完成未知
An open label, multicenter, balanced, randomized, two-treatment, four-period, two-sequence, full replicate crossover, single dose, comparative bioavailability study of Capecitabine Dispersible Tablets 1000 mg of Shilpa Medicare Limited, India with Xeloda�® 500 mg Film-Coated Tablets (Capecitabine) of Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany at a dose of 2000 mg in adult human cancer patients under fed conditions. - AMBRACA
ShilpaMedicareLimited0 个研究点目标入组 35 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 35
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
- •The patients will be considered eligible for the study based on the following criteria:
- •1. Willing and able to provide voluntary informed consent and able to comply with protocol requirements
- •2. Male or Female aged 18 to 65 years (both inclusive) having body mass index (BMI) at least 17.00 calculated as weight in kg/height in m2.
- •3. Patients having Body Surface Area between 1.27-1.92m2 (both inclusive) measured as per the Dubois formula.
- •4. Patients with histopathologically/cytologically confirmed colon or colorectal or breast cancer.
- •5. Patients with Dukesââ?¬• C colon cancer who have undergone complete resection of the primary tumor and when treatment with fluoropyrimidine therapy alone is preferred.
- •Patients with metastatic colorectal carcinoma in whom treatment with fluoropyrimidine therapy alone is preferred.
- •Patients with locally advanced or metastatic breast cancer, after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
- •6. Patients requiring a daily dose of Capecitabine monotherapy and stabilized at least one cycle of Capecitabine chemotherapy (i.e. twice daily at a dose of 1250 mg/m2 for 2 weeks followed by a one- week rest period).
- •7. Cardiac ejection fraction ââ?°Â¥ 50% by echocardiogram (ECHO) within 14 days prior to first dose of Investigational Product.
- •8. Eastern Cooperative Oncology Group (ECOG) performance status ââ?°Â¤ 2.
- •9. Acceptable hematology status:
- •a. Hemoglobin ââ?°Â¥ 9 g/dL
- •b. Absolute neutrophil count (ANC) ââ?°Â¥ 1500 cells/mm3
- •c. Platelet count ââ?°Â¥ 100,000 cells/mm3
- •10. Acceptable liver function:
- •d. Alanine aminotransferase (ALT) ââ?°Â¤ 2.5 X ULN (ââ?°Â¤5 x ULN if liver metastases present)
- •e. Aspartate aminotransferase (AST) ââ?°Â¤ 2.5 X ULN (ââ?°Â¤5 x ULN if liver metastases present)
- •f. Bilirubin ââ?°Â¤ 1.5 X ULN
- •g. Alkaline phosphatase ââ?°Â¤ 2.5 X ULN (ââ?°Â¤5 x ULN if liver metastases present)
- •11. Patients with Creatinine clearance ââ?°Â¥ 60 mL/minute.
- •12. Patients with life expectancy of at least 3 months at the time of enrolment.
- •13. Non-smokers and non-alcoholics
- •14. Female patients with negative serum pregnancy test at screening and negative urine pregnancy test on Day 0.
- •15. Patients who agree to use adequate contraception (e.g., hormonal, chemical, double-barrier methods such as condom or diaphragm with intra-vaginally applied spermicide, or abstinence) while in the study
- •16. No history of addiction to any recreational drug or drug dependence.
- •17. In case of male patients: Either partner or patient must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug or till next chemotherapy cycle.
排除标准
- •The patients will be excluded from the study based on the following criteria:
- •1.Known hypersensitivity or contraindication to fluoropyrimidine therapy or to any of the components of
- •Capecitabine.
- •2.Known hypersensitivity or contraindication to Ondansetron.
- •3.History or presence of any uncontrolled debilitating systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.)
- •4.Known CNS metastasis.
- •5.Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
- •6.Surgical or other non-healing wounds.
- •7.Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- •8.Patients with positive urine screen for Drugs of Abuse.
- •9.History of other malignancies in the last 5 years (except in situ cancer or basal or squamous cell skin cancer).
- •10.Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia (any grade is acceptable), fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V5.0)
- •11.Participation in any clinical study within 90 days prior to receiving the first dose of Investigational Product.
- •12.In patients with severe leukopenia, neutropenia, or thrombocytopenia
- •13.In patients with severe hepatic impairment
- •14.In patients with severe renal impairment (Creatinine clearance below 30 ml/min)
- •15.Severe liver and kidney diseases
- •16.Donation of blood ââ?°Â¥ 350 mL within 90 days prior to receiving the first dose of investigational product for the current study.
- •17.Patients taking or scheduled to receive any of the Cytochrome P450 2C9 substrates (As per appendix B)
- •18.Any other medical condition or serious inter current illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
- •19.Lactating women.
研究者
相似试验
进行中（未招募）
不适用
A study of Capecitabine 200 mg/ ml with Xeloda 500 mg (Capecitabine) at a dose of 2000 mg in adult human cancer patients under fed conditions.CTRI/2020/10/028417Shilpa Medicare Limited
进行中（未招募）
Unknown
euprolide acetate in the treatment of Prostate Cancer.CTRI/2023/09/057619Pharmathen S.A.
已完成
不适用
Imatinib Mesylate Oral Solution 400mg/5ml with Gleevec® (Imatinib mesylate) Tablets 400mg in adult human subjects with Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumors under fed condition.CTRI/2020/03/024404Shilpa Medicare Limited35
已完成
不适用
Open label multicenter randomized parallel single-period single dose bio equivalence study of Leuprolide acetate 30 mg in adult male subjects with advanced prostaticcancer undergoing initial therapy.CTRI/2020/10/028442Pharmathen SA32
已完成
不适用
Bioequivalence study of Capecitabine Tablets USP, 500 mg in adult human cancer patients under fed conditions.CTRI/2022/07/044491ovugen Oncology Sdn Bhd40