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Vasomotor Symptoms (VMS)Phase 2NCT03518138

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

A Phase 2 study testing Q-122 in people with Vasomotor Symptoms (VMS), run by Que Oncology at 18 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Vasomotor Symptoms (VMS)
What is being tested?
Q-122
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
132 participants
Where
18 sitesin 3 countries
Study dates
24 Oct 2018to 9 Sep 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be a female, aged between 18 - 70 years on the day of informed consent.
  • Have a history of or current breast cancer and currently taking tamoxifen or an aromatase inhibitor.
  • 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.
  • 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).
  • 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.
  • Willing and able to complete the daily participant diary, attend all study visits, and participate in all study procedures.
  • Able to provide informed consent.

Who cannot join

  • Childbearing potential, pregnancy, or lactation except in patients who are on stable dose of AI in combination with luteinizing hormone releasing hormone agonists such as Zoladex, Leuprolide (Lupron) or equivalent. 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) confirmed by levels of follicle stimulating hormone (FSH). FSH levels may be lower in menopausal women treated with tamoxifen when compared with FSH levels appropriate for confirming menopause in women not treated with tamoxifen. For those patients who are on stable dose of tamoxifen, confirmation of menopause is based on the clinical opinion of the PI and medical monitor on a 'case-by-case basis'.
  • Currently experiencing undiagnosed vaginal bleeding.
Show all 23Show fewer
  • Women with advanced breast cancer (Stage 4).
  • Greater than 60% reduction in the frequency of moderate to severe 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.
  • 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.
  • Gastrointestinal, liver, kidney or other conditions which could interfere with the absorption, distribution, metabolism or excretion of Q-122 at PI discretion.
  • Untreated overt hyperthyroidism.
  • 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.
  • Known inability to complete all study visits and study assessments for scheduling or other reasons.
  • 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.
  • 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.
  • Uncontrolled systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥95 mmHg on 3 consecutive readings within the screening visit.
  • Abnormal laboratory findings:
  • Hemoglobin < 9.5 g/dL (g/L); or any abnormal values that are deemed clinically significant by the investigator should be discussed with the medical monitor before being deemed ineligible.
  • Fasting ALT, AST, GGT, or bilirubin greater than twice the upper limit of normal that is confirmed on a second sample.
  • <60 eGFR mL/min/1.73 m2.
  • In the opinion of the investigator, have substantial risk of disease progression within the 3 months following screening and/or who potentially may require further treatment for their breast cancer during the study period including follow-up.
  • Any other reason which in the investigator's opinion makes the participant unsuitable for a clinical trial.
  • On any medications, either prescription or over-the-counter that are being taken solely for the purpose of treating VMS including SSRI/SNRI, gabapentin or pregabalin.

Trial locations and contacts

18 sites in 3 countries.

18 sites in 3 countries

Australia7 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • ICON Group, Icon Cancer Care Wesley

    Brisbane, 4066

  • School of Public Health and Preventive Medicine, Monash University

    Melbourne, 3004

  • The Royal Women's Hospital

    Melbourne, 3052

  • Keogh Institute for Medical Research

    Perth, 6009

  • Women's Health Research Institute of Australia

    Sydney, 2000

  • Royal North Shore Hospital

    Sydney, 2065

Other trials in Australia

United States6 sites

  • John Hopkins

    Baltimore, Maryland, 21287

  • Brighams and Women's Hospital

    Boston, Massachusetts, 02115

  • Indiana University School of Nursing

    Indianapolis, Indiana, 46202

  • Stony Brook University

    Stony Brook, New York, 11794

  • Baylor Scoot & White Medical Center

    Temple, Texas, 76508

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

Other trials in United States

New Zealand5 sites

  • Optimal Clinical Trials

    Auckland, 1010

  • Auckland City Hospital

    Auckland, 1023

  • Christchurch Clinical Studies Trust Ltd

    Christchurch, 8011

  • P3 Research - Hawkes Bay

    Havelock North, 4130

  • P3 Research - Tauranga

    Tauranga, 3110

Other trials in New Zealand

About this study

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

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.

Read the 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.

Being tested
Q-122, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Q-122Drug

    oral capsule of Q-122

  • PlaceboDrug

    oral capsule of placebo

Study groups in NCT03518138
Study groupRoleWhat they receive
Group 1, study drugExperimental65 patients treated with Q-122, 100 mg BID
Receives: Drug: Q-122
Group 2, placeboPlacebo comparator65 patients treated with placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hot Flash Severity Score (HFSS)

    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)

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2018
  2. Study start24 Oct 2018
  3. Primary completion29 Jul 2020
  4. Study completion9 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03518138
Sponsor's protocol ID
Q122-2001
Status last verified
Jul 2021
First submitted
25 Apr 2018
Last updated
23 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Vrselja A, Latifi A, Baber RJ, Stuckey BGA, Walker MG, Stearns V, Hickey M, Davis SR. Q-122 as a novel, non-hormonal, oral treatment for vasomotor symptoms in women taking tamoxifen or an aromatase inhibitor after breast cancer: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2022 Nov 12;400(10364):1704-1711. doi: 10.1016/S0140-6736(22)01977-8.

    PubMed 36366886

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Q-122 in people with Vasomotor Symptoms (VMS), run by Que Oncology at 18 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Australia, United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hot Flash Severity Score (HFSS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03518138, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.

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