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

• Status: Completed
• Trial end date: 2014-07-28
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Que Oncology
• Treatments: Aromatase Inhibitors; Tamoxifen

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