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Study record managers: refer to the Data Element Definitions if submitting registration or results information. This is a single arm Phase I study with multiple dosing cohorts as noted below:. Schedule B: Intravenous infusion on Days 1, 8, 15 for a day treatment cycle. Dose escalation stage Schedule A: Intravenous infusion on Days 1, 4, 8, 11 for a day treatment cycle. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Each participant must meet all of the following inclusion criteria to be enrolled in the study:. Female participants who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 4 months after the last dose of study drug, or agree to practice true abstinence. Male participants who agree to practice effective barrier contraception during the entire study treatment period through 4 months after the last dose of study drug or agree to practice true abstinence.
Participants meeting any of the following exclusion criteria are not to be enrolled in the study:. For participants where tumor biopsies are required or requested:.
Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms x.