Solid Tumor Clinical Trial
Official title:
A Phase Ⅰb Study Evaluating the Safety, Tolerability and Pharmacokinetics of Pegylated Recombinant Human Endostatin (PEG-ENDO) in Subjects With Advanced / Metastatic Non-small Cell Lung Cancer (NSCLC) or Other Solid Tumors
The primary purpose of this study is to examine the safety, tolerability and pharmacokinetics of PEG-ENDO in combination with docetaxel in subjects previously treated or untreated (standard therapy is not suitable or without standard therapy) for advanced or metatatic non-small cell lung cancer (NSCLC) or other solid tumors.
This is a multicenter, open-label, dose-escalation study in subjects with advanced or
metatatic non-small cell lung cancer (NSCLC) or other solid tumors.There will be five cohorts
planning as following:
cohort 1: PEG-ENDO 1 mg/kg+Docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 2: PEG-ENDO
2mg/kg+Docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 3: PEG-ENDO 4 mg/kg+Docetaxel 75
mg/m2,once every 3 weeks at day 1 cohort 4: PEG-ENDO 6 mg/kg+Docetaxel75 mg/m2,once every 3
weeks at day 1 cohort 5: PEG-ENDO 8 mg/kg+Docetaxel75 mg/m2, once every 3 weeks at day 1
* Every 3 weeks as a treatment cycle. Subjects received only PEG-ENDO in the first cycle. For
second cycle or the higher, they received a combination therapy of PEG-ENDO and docetaxel.
Docetaxel was limited in 4 or 6 cycles。 The observation period of DLT was the 21 days after
the first administration of PEG-ENDO. During the observation period of DLT (cycle 1),
subjects only receive the corresponding dose of PEG-ENDO , for the second cycle and higher
,they will treated with the combination of PEG-ENDO and Docetaxel until disease progression
(PD) or intolerance . Docetaxel was limited in 4 or 6 cycles。
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