An Open Label, Balanced, Randomized, Two Period, Two Treatment, Two Sequence,Crossover, Multicentric Study to Evaluate Safety and Pharmacokinetic Comparison of Intravenous Infusion of Docetaxel Lipid Suspension and TAXOTEREÂ® (Docetaxel Injection Concentrate) in Advanced Solid Tumor Patients

Intas Pharmaceuticals Limited India0 个研究点目标入组 32 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.The patient must have given written, personally signed and dated, informed consent to participate in the study before initiating any study related procedures.
•2. Male and Female ≥18 years and < 65 years of age and having a Body Mass Index (BMI) at least 17 calculated as weight in kg / height in m2.
•3. Must have histopathologically /cytologically confirmed following primary tumors:
•Breast cancer, Head and neck, Lung, Melanoma, or Prostate for which docetaxel is a viable treatment option.
•4.Able to comply with study requirement in opinion of Principal Investigator.

•1.Patient having hypersensitivity to Docetaxel injection
•2. Intolerance to any antineoplastic agents belonging to the taxoid family.
•3. Prior anticancer therapy within 21 days prior to the first day of study treatment.
•4. Participation in another experimental drug study within 30 days prior to the first day of study treatment.
•5.If bilirubin > ULN, or if SGOT and/or SGPT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN.
•6. If neutrophil counts are < 1500 cells/mm3
•7.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

发起方

Intas Pharmaceuticals Limited India