A Phase 4 interventional study of Liposomal paclitaxel and Paclitaxel in Cancer, sponsored by Shandong Luye Pharmaceutical Co., Ltd.. Completed at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-02-10.
Sponsored by Shandong Luye Pharmaceutical Co., Ltd. (part of Luye Pharma Group Ltd.) · Phase 4 and Interventional
The purpose of this study is to determine whether there is any difference of the pharmacokinetics of two taxane formulations, paclitaxel injection and liposomal paclitaxel in Chinese cancer patients with solid tumors.
The pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) has never been studied in Chinese cancer patients. This clinical trial is designed to find out the pharmacokinetics of liposomal paclitaxel at the dose of 175mg/m2 and whether it has a different pharmacokinetic profile to paclitaxel.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's planned enrollment of 16 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Shandong Luye Pharmaceutical Co., Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Liposomal paclitaxel
Drug: Liposomal paclitaxel
Paclitaxel
Drug: Paclitaxel
Patients will be given Liposomal paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy.
Patients will be given paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy.
Pharmacokinetic parameters
Time frame: 72 hours after the infusion
This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Paclitaxel Liposome
Shandong Luye Pharmaceutical Co., Ltd. →