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The study is an open-label, two dose study (Group 1: 100 mg once daily and Group 2: 200 mg once daily) of Q-122, over a 4 week treatment period. As eligible subjects are enrolled, they will be assigned to Group 1 until Group 1 is fully enrolled. No subjects will be enrolled into Group 2 until Group 1 is filled. Dose escalation tot he 200 mg level will only occur following a review of the safety experience of at least 6 subjects treated with 100 mg Q-122 once daily for at least 2 weeks.
Vasomotor symptoms are significant in postmenopausal women with the most effective medications for relief being hormonal preparations. Non-hormonal medications have demonstrated efficacy but at a far lower level than estrogen replacement therapy. For women with a history of breast cancer hormone replacement therapy is problematic especially if their therapeutic regime involves an aromatase inhibitor. Therefore, this study will explore the effect of Q-122 in a population of women with a history of breast cancer taking an aromatase inhibitor or Tamoxifen.
A two-week, study free screening phase will be used to establish a stable baseline of vasomotor symptoms and to establish study eligibility. Qualified subjects will be treated with Q-122 for four weeks either at 100 mg/day dose or the 200 mg/day dose, during which time they will be evaluated for safety, tolerability, and pharmacokinetics of Q-122 and Tamoxifen; subjects will continue to record their hot flashes in identical fashion to the screening period. A safety review will be conducted after 6 subjects have completed two weeks of dosing in the 100 mg dose group before any subjects are enrolled at the 200 mg daily dose.
Vasomotor Symptoms (VMS)
oral capsule of Q-122
Published on BioPortfolio: 2019-09-12T02:34:42-0400
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