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Dose Escalation Study in Female Subjects With Breast Cancer Receiving Aromatase Inhibitor or Tamoxifen

2019-09-12 02:34:42 | BioPortfolio

Summary

Open-label, two dose study of Q-122, over a 4 week treatment period to explore the effect of Q-122 in a population of women with a history of breast cancer taking an aromatase inhibitor or Tamoxifen.

Description

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.

Study Design

Conditions

Vasomotor Symptoms (VMS)

Intervention

oral capsule of Q-122

Status

Completed

Source

Que Oncology

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-12T02:34:42-0400

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Medical and Biotech [MESH] Definitions

The use of hormonal agents with estrogen-like activity in postmenopausal or other estrogen-deficient women to alleviate effects of hormone deficiency, such as vasomotor symptoms, DYSPAREUNIA, and progressive development of OSTEOPOROSIS. This may also include the use of progestational agents in combination therapy.

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