A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Q-122 for the Treatment of Vasomotor Symptoms in Female Breast Cancer Patients/Survivors Taking Tamoxifen or an Aromatase Inhibitor
Johns Hopkins Kimmel Cancer Center in Baltimore
Vasomotor symptoms (VMS) 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 often contraindicated and is not an option for women receiving endocrine therapy including tamoxifen (TAM) and aromatase inhibitors (AI). Breast cancer survivors, and women receiving endocrine therapy in particular, have a high rate of problematic hot flashes. In an open label Phase 1 study of the safety and activity of Q-122 in breast cancer patients taking TAM or an AI, 8 of 9 women who received at least 1 dose of 100 mg and 10 of 11 women who received at least 1 dose of 200 mg had a reduction in hot flashes of 2 or more per day, the FDA criteria for anti-VMS activity. This study will define the effect of Q-122 versus placebo in a population of women with a history of or current breast cancer who have an average of 50 or more moderate to severe hot flashes per week.
To be eligible, a participant must meet the following criteria:1. Be a female, aged between 18 to 70 years on the day of informed consent2. Have a history of or current breast cancer3. On a stable dose of TAM or an AI for a minimum of 30 days before the Screening Visit and no anticipated need to change the dose for the duration of the study.4. Experience an average of at least 50 moderate to severe hot flashes/week for the 2 weeks immediately preceding the Run-In Visit (i.e., during the Screening period).5. If on thyroid medication, on a stable dose for a minimum of 30 days before the Screening Visit and no anticipated need to change the dose for the duration of the study.6. If taking an SSRI or SNRI, on a stable dose for a minimum of 30 days before the Screening Visit and no anticipated need to change the dose for the duration of the study.7. Willing and able to complete the daily participant diary, attend all study visits, and participate in all study procedures8. Able to provide informed consent
This is a Phase 2 proof-of-concept (POC) study designed to determine the effectiveness of Q-122 for the treatment of VMS versus placebo. Participants who meet all eligibility criteria following the Screening/Run-In period will be randomized to 1 of 2 treatment arms; blinded Q-122 or placebo for a period of 28 days. All participants will be followed for a 2 week, drug-free, follow-up period after their last dose of blinded Q-122/placebo before termination from the study.
03/05/2019 05:03 AM