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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03518138




Registration number
NCT03518138
Ethics application status
Date submitted
25/04/2018
Date registered
8/05/2018

Titles & IDs
Public title
Safety/Efficacy of Q-122 in Breast Cancer Patients Taking Tamoxifen or Aromatase Inhibitor
Scientific 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
Secondary ID [1] 0 0
Q122-2001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vasomotor Symptoms (VMS) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Q-122
Treatment: Drugs - Placebo

Experimental: Group 1, study drug - 65 patients treated with Q-122, 100 mg BID

Placebo comparator: Group 2, placebo - 65 patients treated with placebo


Treatment: Drugs: Q-122
oral capsule of Q-122

Treatment: Drugs: Placebo
oral capsule of placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hot Flash Severity Score (HFSS)
Timepoint [1] 0 0
4 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/09/2020
Sample size
Target
Accrual to date
Final
132
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
ICON Group, Icon Cancer Care Wesley - Brisbane
Recruitment hospital [3] 0 0
School of Public Health and Preventive Medicine, Monash University - Melbourne
Recruitment hospital [4] 0 0
The Royal Women's Hospital - Melbourne
Recruitment hospital [5] 0 0
Keogh Institute for Medical Research - Perth
Recruitment hospital [6] 0 0
Women's Health Research Institute of Australia - Sydney
Recruitment hospital [7] 0 0
Royal North Shore Hospital - Sydney
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4066 - Brisbane
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3052 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Perth
Recruitment postcode(s) [6] 0 0
2000 - Sydney
Recruitment postcode(s) [7] 0 0
2065 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
New Zealand
State/province [7] 0 0
Auckland
Country [8] 0 0
New Zealand
State/province [8] 0 0
Christchurch
Country [9] 0 0
New Zealand
State/province [9] 0 0
Havelock North
Country [10] 0 0
New Zealand
State/province [10] 0 0
Tauranga

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Que Oncology
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Syneos Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03518138