An open label, multicentric, dose ranging, single dose study to evaluate safety, tolerability & pharmacokinetics of Cabazitaxel lipid suspension for injection (Manufactured by Intas Pharmaceuticals Ltd.) in comparison with JEVTANAÂ® (Cabazitaxel) injection (Manufactured by Sanofi-aventis) in patients with advanced solid malignancies refractory to conventional treatment. - NA

Intas Pharmaceuticals Ltd0 个研究点目标入组 33 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Patient and /or LAR or impartial witness able to give written informed consent for participation in the trial.
•2.Male or female patients with age >= 18 years at the screening visit.
•3.Patients with histopathologically/cytologically confirmed following primary advanced solid tumors: Breast cancer, Head and neck, Lung, Melanoma, gastric, colon or Prostate for which Cabazitaxel monotherapy is a viable treatment option.
•4.Patients with advanced solid malignancies refractory to conventional treatment.
•5.Patient with an ECOG performance status of 0-2.
•6.Patient must have an adequate bone marrow, renal and hepatic function
•7.Patient should be able to comply with study procedures in the opinion of the investigator.
•8.Life expectancy should be >2 months

•1.Known hyper sensitivity to Cabazitaxel or any of its excipients or related group of drugs.
•2.Intolerance to any antineoplastic agents belonging to the taxane family.
•3.If the patient had undergone prior surgery, radiation, chemotherapy, or other anticancer therapy within 4 weeks (28 days) prior to dosing in the study
•4.Patients with known human immunodeficiency virus (HIV) infection.
•5.A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
•6.Use of any recreational drugs or history of drug addiction.
•7.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.
•8.Any other condition or abnormal baseline findings that, in the investigatorâ??s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.

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