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

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ClinicalTrials.gov Identifier: NCT03518138
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Que Oncology

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vasomotor Symptoms (VMS) Drug: Q-122 Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tamoxifen

Arm Intervention/treatment
Experimental: Group 1, study drug
65 patients treated with Q-122, 100 mg BID
Drug: Q-122
oral capsule of Q-122

Placebo Comparator: Group 2, placebo
65 patients treated with placebo
Drug: Placebo
oral capsule of placebo




Primary Outcome Measures :
  1. Hot Flash Severity Score (HFSS) [ Time Frame: 4 weeks ]
    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)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518138


Locations
United States, Massachusetts
Brighams and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Aleta Wiley    617-525-9627    awiley1@bwh.hardvard.edu   
Principal Investigator: Hadine Joffe         
Australia
Royal Adelaide Hospital Not yet recruiting
Adelaide, Australia, 5000
Contact: Lisa Leopardi    61 0882226759    lisa.leopardi@sa.gov.au   
Principal Investigator: Robert Whitfield         
School of Public Health and Preventive Medicine, Monash University Recruiting
Melbourne, Australia, 3004
Contact: Corallee Morrow    61 0399030836    corallee.morrow@monash.edu   
Principal Investigator: Susan Davis         
Keogh Institute for Medical Research Recruiting
Nedlands, Australia, 6009
Contact: Lee Mahoney    61 0893464402    lee@kimr.org   
Contact: Smilja Gragovic    61 0864572475    smilja@kimr.org   
Principal Investigator: Bronwyn Stuckey         
The Royal Women's Hospital Not yet recruiting
Parkville, Australia, 3052
Contact: Shona Darby    61 0383452217    shona.darby@thewomens.org.au   
Contact: Soula Krejany    61 0383453719    soula.krejany@thewomens.org.au   
Principal Investigator: Martha Hickey         
Royal North Shore Hospital Not yet recruiting
Saint Leonards, Australia, 2065
Contact: Liza Nery    61 0294631864    liza.nery@health.nsw.gov.au   
Contact: Rhonda Siddall         
Principal Investigator: Rodney Baber         
Women's Health Research Institute of Australis Recruiting
Sydney, Australia, 2000
Contact: Jinzhu Liu    61 0293826278    jz.liu@unsw.ed.au   
Principal Investigator: John Eden         
Sponsors and Collaborators
Que Oncology
Syneos Health

Responsible Party: Que Oncology
ClinicalTrials.gov Identifier: NCT03518138     History of Changes
Other Study ID Numbers: Q122-2001
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tamoxifen
Aromatase Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action