Transcription of Dose Escalation Study Design Example Record
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Is a service of the National Institutes of Health. dose Escalation Study Design Example 1 of 22 September 2019 (With Results) dose Escalation Study Design Example (With Results) Disclaimer: The following information is fictional and is only intended for the purpose of illustrating key concepts for results data entry in the Protocol Registration and Results System (PRS). The safety and scientific validity of this Study is the responsibility of the Study sponsor and investigators. Listing a Study does not mean it has been evaluated by the Federal Government. Read our disclaimer for details. ! Identifier: NCT00055581 Recruitment Status: Completed First Posted: January 2, 2018 Results First Posted: July 31, 2019 Last Update Posted: July 31, 2019 Sponsor: PRS Results Training Information provided by (Responsible Party): PRS Results Training Study Description Brief Summary: The primary aim of the Study is to establish the maximum-tolerated dose (MTD) of Ender-G in participants with cancer.
Dose Escalation Study Design Example 2 of 22 September 2019 (With Results) 100 mg/m^2, via intravenous catheter (IV), twice a day for 4 weeks for the first cohort. Successive cohorts will be given doses of 125 and 150 mg/m^2 twice a day. Dose escalation will continue until the maximum-tolerated dose (MTD), defined as one dose level below
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