Clinical Trials /

Safety/Efficacy of Q-122 in Breast Cancer Patients Taking Tamoxifen or Aromatase Inhibitor

NCT03518138

Description:

This is a Phase 2 proof-of-concept (POC) study designed to determine the effectiveness of Q-122 for the treatment of Vasomotor Symptoms (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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Safety/Efficacy of Q-122 in Breast Cancer Patients Taking Tamoxifen or Aromatase Inhibitor
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: Q122-2001
  • NCT ID: NCT03518138

Conditions

  • Vasomotor Symptoms (VMS)

Interventions

DrugSynonymsArms
Q-122Group 1, study drug
PlaceboGroup 2, placebo

Purpose

This is a Phase 2 proof-of-concept (POC) study designed to determine the effectiveness of Q-122 for the treatment of Vasomotor Symptoms (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.

Detailed Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
Group 1, study drugExperimental65 patients treated with Q-122, 100 mg BID
  • Q-122
Group 2, placeboPlacebo Comparator65 patients treated with placebo
  • Placebo

Eligibility Criteria

        Inclusion Criteria:

          1. Be a female, aged between 18 - 70 years on the day of informed consent

          2. Have a history of or current breast cancer and currently taking tamoxifen or an
             aromatase inhibitor

          3. 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 procedures

          8. Able to provide informed consent

        Exclusion Criteria:

          1. Childbearing potential, pregnancy, or lactation. Non-childbearing potential is defined
             as physiologically incapable of becoming pregnant by one of the following:

               -  Has had a partial or complete hysterectomy or

               -  Has had a bilateral oophorectomy or

               -  Has had a bilateral tubal ligation or fallopian tube inserts or

               -  Is post-menopausal (amenorrhea > 1 year in women over 55) confirmed by levels of
                  follicle stimulating hormone (FSH)

          2. Currently experiencing undiagnosed vaginal bleeding

          3. Women with advanced breast cancer (Stage 4)

          4. Greater than 60% reduction in the frequency of hot flashes during the 1-week single
             blind Run-In period or inability to correctly record hot flashes and/or drug dosing in
             the participant diary

          5. Participation in another clinical or surgical trial within 30 days prior to screening
             or during the study without the prior written consent of the Medical Monitor

          6. Gastrointestinal, liver, kidney or other conditions which could interfere with the
             absorption, distribution, metabolism or excretion of Q-122

          7. Untreated overt hyperthyroidism

          8. Have any other medical condition, clinically important systemic disease or significant
             co-morbidities or any finding during Screening that in the judgment of the
             investigator puts the participant at increased risk by participation in this study, or
             that may affect the reliability of participant diary entries

          9. Known inability to complete all study visits and study assessments for scheduling or
             other reasons

         10. BMI > 40 kg/m2; Participants with a BMI greater than 40 kg/m2 may be enrolled on a
             case-by-case basis if approved by the Medical Monitor and if the participant is not
             deemed at increased risk of adverse effects based on body habitus and cardiovascular
             health

         11. Women with a history of, or current evidence of, abuse of alcohol or any drug
             substance, or who regularly drink more than 3 standard drinks per day

         12. Uncontrolled systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥95 mmHg
             confirmed following 3 individual readings

         13. Abnormal laboratory findings:

               1. Hemoglobin < 9.5 gm/dL (g/L); or any abnormal values that are deemed clinically
                  significant by the investigator

               2. Fasting ALT, AST, GGT, or bilirubin greater than twice the upper limit of normal
                  that is confirmed on a second sample.

               3. <60 eGFR mL/min/1.73 m2

         14. Any other reason which in the investigator's opinion makes the participant unsuitable
             for a clinical trial.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Hot Flash Severity Score (HFSS)
Time Frame:4 weeks
Safety Issue:
Description:The primary efficacy outcome measure will be the change from baseline in the HFSS for moderate and severe hot flashes (HFSS-m/s) calculated for each treatment week by multiplying the severity by the frequency using the following formula: (2 x number of moderate) + (3 x number of severe)

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Que Oncology

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