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

July 19, 2021 updated by: Que Oncology

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Royal Adelaide Hospital
      • Brisbane, Australia, 4066
        • ICON Group, Icon Cancer Care Wesley
      • Melbourne, Australia, 3004
        • School of Public Health and Preventive Medicine, Monash University
      • Melbourne, Australia, 3052
        • The Royal Women's Hospital
      • Perth, Australia, 6009
        • Keogh Institute for Medical Research
      • Sydney, Australia, 2065
        • Royal North Shore Hospital
      • Sydney, Australia, 2000
        • Women's Health Research Institute of Australia
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Auckland, New Zealand, 1010
        • Optimal Clinical Trials
      • Christchurch, New Zealand, 8011
        • Christchurch Clinical Studies Trust Ltd
      • Havelock North, New Zealand, 4130
        • P3 Research - Hawkes Bay
      • Tauranga, New Zealand, 3110
        • P3 Research - Tauranga
  • United States
    • Georgia
      • Woodstock, Georgia, United States, 30189
        • North Georgia Clinical Research
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Nursing
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • John Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brighams and Women's Hospital
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University
    • Texas
      • Temple, Texas, United States, 76508
        • Baylor Scoot & White Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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. Willing and able to complete the daily participant diary, attend all study visits, and participate in all study procedures.
  7. Able to provide informed consent.

Exclusion Criteria:

  1. 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'.
  2. Currently experiencing undiagnosed vaginal bleeding.
  3. Women with advanced breast cancer (Stage 4).
  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.
  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 at PI discretion.
  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 on 3 consecutive readings within the screening visit.

  13. Abnormal laboratory findings:

    1. 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.
    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. 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.
  15. Any other reason which in the investigator's opinion makes the participant unsuitable for a clinical trial.
  16. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Que Oncology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Syneos Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 24, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 9, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Q122-2001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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