CTRI/2024/05/068024尚未招募Unknown
A Randomized Open label Single Dose Two Treatment Three Period Three SequencePartial Replicate Crossover Multicentre Bioequivalence Study of Capecitabine Biopharm500 mg film coated Tablets (Manufactured by Profam Algeria for Biopharm SPA Algeria) with Xeloda 500 mg Film Coated Tablets Capecitabine (Manufacturer Roche Registration GmbH Germany) in Adult Cancer Patients Under Fed Conditions - NI
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- BIOPHARM SPA
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 Males or non-pregnant or non-lactating females of age between greater than 18 to 60 years (both inclusive)
- •2 Patients in whom capecitabine therapy is indicated Dukes’ C colon cancer Single agent as adjuvant therapy or Metastatic colorectal cancer First line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred or
- •Metastatic Breast Cancer As monotherapy in patients resistant to both paclitaxel and an anthracycline containing regimen
- •3 Patients already receiving a stable twice-daily dosing regimen of capecitabine (1250 mg/m2 twice daily equivalent to 2500 mg/m2 total daily dose for two-weeks followed by a one-week
- •rest period given as three-week cycles)
- •4 Patients with Eastern Cooperative Oncology Group (ECOG) performance status = 2
- •5 Patients with life expectancy of at least 3 months
- •6 Adequate cardiac function [left ventricular ejection fraction LVEF = 50 %
- •7 Patient with adequate
- •- Bone marrow (ANC = 1500/mm3, Platelet count =
- •100,000/mm3 Hemoglobin = 9.0 g/dL)
- •- Renal (Serum Creatinine = 1.5 times ULN and creatinine clearance = 51 to 80 mL/min [Cockroft and Gault]) and
- •- Hepatic function (Bilirubin = 1.5 times ULN, ALT/AST = 3 times ULN (= 5 x ULN if liver metastases present))
- •8 Patients should be non-smokers
- •9 Patient willing and able to give written informed consent for participation in the study and comply with the study protocol
- •10 No persistent clinically significant toxicities from prior medications at screening.
- •11 Females of child-bearing potential must agree to use an acceptable method of birth control such as sexual abstinence or at least reliable modes of contraception from screening until 3 months after last dose of study drug
- •[Note Use of hormonal contraception(pills/hormonal
- •intrauterine device etc) is not allowed
- •OR Post-menopausal females defined as at least 12 consecutive months with no menses without an alternative medical cause
- •OR surgically sterilized females with documented evidence of hysterectomy/bilateral salpingectomy/bilateral oophorectomy
- •12 Male patient must agree to use an acceptable method of birth control such as sexual abstinence or barrier method of contraception (condom) from screening until 3 months after last dose of study drug Subject agrees to accept the risk that
- •pregnancy in female partner could still result despite using birth control devices
- •13 Cancer patients should preferably be on monotherapy However cancer patients receiving concomitant drug(s) are allowed to participate provided
- •- The concomitant medication is the same for all the study
- •period and clearly documented.
- •- Patients do not require any change in their concurrent
- •medications during the study period
排除标准
- •1 Patients with known hypersensitivity to capecitabine or to any of its components of formulation or 5-fluorouracil
- •2 Patients with known DPD (Dihydro pyrimidine
- •Dehydrogenase) deficiency
- •3 Prior unanticipated severe reaction to Capecitabine or metabolites and to fluoropyrimidine therapy
- •4 Patients with a prior history of coronary artery disease
- •5 Patients who are on oral-coumarin derivative anticoagulants such as warfarin or phenprocoumon at the time of screening or anticipated use of these drugs during the study period[If the
- •subject was on any of these drugs before screening a wash out
- •19 Patient having abnormal serum calcium level at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial period of at least 5 half-lives must have elapsed since the last
- •dose of such drug
- •6 Patients receiving concomitant therapy of Phenytoin Leucovorin and CYP2C9 substrates at the time of screening or anticipated use of these drugs during the study period [If the
- •subject was on any of these drugs before screening a wash out period of at least 5 half-lives must have elapsed since the last dose of such drug] Presence of active infections
- •7 Patients with known brain metastasis.
- •8 Pre-existing motor or sensory neurotoxicity of severity = 2 by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) criteria
- •9 Use of any recreational drugs or history of drug addiction
- •10 Have a history of alcohol or drug-dependence as per DSM-IV criteria during the 6-month period immediately prior to Screening
- •11 Consumption of grapefruit grapefruit-like or grapefruit containing products within 7 days prior to study drug administration
- •12 Use of enzyme modifying drugs within 30 days prior to study drug administration They can be allowed depending on Principal Investigator’s discretion if they are kept constant in
- •the last 30 days and are expected to remain constant during the study period
- •13 Major surgery to the gastrointestinal tract, liver or kidney within 3 months prior to study entry which may affect the pharmacokinetics of capecitabine
- •14 History of difficulty in swallowing or any gastrointestinal disease e.g. ulcerative colitis ulcerative stomatitis malabsorption syndrome and/or lack of physical integrity of the
- •upper intestinal tract which could affect drug absorption
- •15 History or presence of cardiac disease including myocardial infarction unstable angina coronary artery disease heart failure dysrhythmias cardiomyopathy significant pericardial
- •disease or any other cardiac illness that could affect patient safety
- •16 Electrocardiographic evidence of acute ischemic or active conduction system abnormalities
- •17 History or evidence of uncontrolled coagulopathy.
- •18 Patients with severe hepatic or renal impairment
- •19 Patient having abnormal serum calcium level at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial
- •20 Patients who have had experienced a severe mucocutaneous reaction during prior capecitabine treatment
- •21 History of difficulty with donating blood or difficulty in accessibil
研究者
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