Dose Escalation Study in Female Subjects With Breast Cancer Receiving Aromatase Inhibitor or Tamoxifen
Condition: Vasomotor Symptoms (VMS)
MeSH terms: Breast Neoplasms
Intervention: oral capsule of Q-122
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: open-label, two dose study
Masking: None (Open Label)
Enrollment: 21.0
Sex: Female
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Vasomotor Symptoms, Breast Cancer, Hot Flashes, Tamoxifen, Aromatase Inhibitors, Estrogen Antagonists, Hormone Antagonists, Hormones, Hormone Substitutes; Hormone Antagonists, Physiological Effects of Drugs, Antineoplastic Agents, Hormonal Antineoplastic, Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators, Bone Density Conservation Agents, Steroid Synthesis Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action

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

Eligibility criteria:

        Inclusion Criteria:

          -  Be a female of any race between the ages of 30-70 years.

          -  History of breast cancer and presently taking an aromatase inhibitor or tamoxifen.

          -  Naturally menopausal: ≥ 12 months spontaneous amenorrhea or > 6 but < 12 months
             amenorrhea with a serum follicle stimulating hormone (FSH) level of > 40 mIU/mL
             (Milli-international Units Per Milliliter).

          -  Surgically menopausal with an FSH level > 40 mIU/mL.

          -  Have a minimum of 7 moderate to severe hot flushes/day or 50 moderate to severe hot
             flushes per week, as verified for both weeks during the 14-day Screening Phase, prior
             to enrollment into the treatment phase of the study.

          -  Able to read, understand and complete the required subject diary.

          -  Willing and able to complete the daily subject diary, attend all study visits, and
             participate in all study procedures, including PK blood draws.

        Exclusion Criteria:

          -  Childbearing potential, including pregnancy, or lactation.

          -  Undiagnosed abnormal genital bleeding.

          -  Significant day-to-day variability in hot flushes.

          -  Participation in another clinical trial within 30 days prior to screening or during
             the study.

          -  Legal incapacity or limited legal capacity.

          -  Chronic renal (serum creatinine > 2.0 mg/dL) or hepatic disease [SGPT (ALT) or SGOT
             (AST) > 2X normal limits].

          -  Gastrointestinal, liver, kidney or other conditions which could interfere with the
             absorption, distribution, metabolism or excretion of Q-122.

          -  Untreated overt hyperthyroidism.

          -  Use of thyroid medication of less than 12 weeks on a stable dose.

          -  Any clinically important systemic disease in the judgement of the investigator.

          -  Inability to complete all study visits and study assessments for scheduling or other
             reasons.

          -  Any other reason which in the investigator's opinion makes the subject unsuitable for
             a clinical trial.

          -  Abnormal laboratory findings including:

               1. Hematocrit < 30% or hemoglobin < 9.5 gm/dL

               2. Fasting blood sugar > 140 mg/dL

               3. Fasting serum triglycerides > 300 mg/dL

               4. Fasting SGOT, SGPT, GGT, or bilirubin greater than twice the upper limit of
                  normal (a subject will not be excluded if a second measurement is less than twice
                  the upper limit of normal)

               5. Creatinine > 2.0 mg/dL