CompletedPhase 1

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

21 participantsStarted 2014-01-10

Plain-language 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.

Who can participate

Age range30 Years – 70 Years

SexFEMALE

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Exclusion criteria

✕. Hematocrit \< 30% or hemoglobin \< 9.5 gm/dL
✕. Fasting blood sugar \> 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

What they're measuring

Adverse Event (AE) Reporting of Q-122

Timeframe: 4 weeks

Serious Adverse Event (SAE) Reporting of Q-122

Timeframe: 4 weeks

Change in Frequency of Moderate to Severe Vasomotor Symptoms.

Timeframe: Baseline to 4 weeks

Percent Change in Frequency of Moderate to Severe Vasomotor Symptoms.

Timeframe: Baseline to 4 weeks

Trial details

NCT IDNCT04080297

SponsorQue Oncology

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-07-28

Results submitted2020-01-17

View on ClinicalTrials.gov More Vasomotor Symptoms (VMS) trials