Phase 1
Completed N=21
Dose Escalation Study in Female Subjects With Breast Cancer Receiving Aromatase Inhibitor or Tamoxifen
Vasomotor Symptoms (VMS)
Source: ClinicalTrials.gov NCT04080297 ↗
Enrolled (actual)
21
Serious AEs
4.8%
Results posted
Feb 2020
Primary outcomePrimary: Adverse Event (AE) Reporting of Q-122 — 7; 7 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Event (AE) Reporting of Q-122 |
7; 7 | — |
| PRIMARY Serious Adverse Event (SAE) Reporting of Q-122 |
0; 1 | — |
| PRIMARY Change in Frequency of Moderate to Severe Vasomotor Symptoms. |
9.86; 8.58; -5.81; -5.60 | — |
| PRIMARY Percent Change in Frequency of Moderate to Severe Vasomotor Symptoms. |
-61.46; -67.55 | — |
| SECONDARY Change in Hot Flash Severity Score |
24.91; 20.64; 17.67; 10.09; 12.41; 9.51 | — |
| SECONDARY Percent Change in Hot Flash Severity Score |
-61.97; -67.55 | — |
| SECONDARY Symptoms Associated With Postmenopausal Status |
18.1; 19.1; 6.5; 4.5 | — |
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 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:
- Hematocrit 140 mg/dL
- Fasting serum triglycerides > 300 mg/dL
- 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)
- Creatinine > 2.0 mg/dL
Data sourced from ClinicalTrials.gov (NCT04080297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.