Abstract | OBJECTIVE: METHODS: This phase I, single-center clinical trial had 2 phases of treatment: single-dose phase, followed by a fixed weekly dose. Subjects meeting the inclusion criteria were enrolled. The subjects were randomly assigned to receive 1 of 3 initial doses of CMAB009 (100, 250 & 400 mg/m(2)) for the purpose of single-dose pharmacokinetic evaluation. After a 28-day washout period of allowing for the characterization of pharmacokinetic end points, the eligible patients were permitted to undergo a successive multi-dose phase study. They were divided into 2 dose groups, group A with 4 weekly doses of 250 mg/m(2), group B with the initial dose of 400 mg/m(2), followed by 3 weekly doses of 250 mg/m(2). The subjects were closely monitored for adverse events throughout the trial. RESULTS: CONCLUSION:
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Authors | Xiao-Hui He, Yuan-Kai Shi, Yan Qin, Sheng Yang, Yan Sun |
Journal | Zhonghua yi xue za zhi
(Zhonghua Yi Xue Za Zhi)
Vol. 91
Issue 33
Pg. 2333-5
(Sep 06 2011)
ISSN: 0376-2491 [Print] China |
PMID | 22321747
(Publication Type: Journal Article)
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Chemical References |
- Antibodies, Monoclonal, Humanized
- Antineoplastic Agents
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Topics |
- Antibodies, Monoclonal, Humanized
(therapeutic use)
- Antineoplastic Agents
(therapeutic use)
- Carcinoma, Non-Small-Cell Lung
- Colorectal Neoplasms
(drug therapy)
- Fever
- Humans
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