Vasomotor Symptoms (VMS)Phase 1NCT04080297
Dose Escalation Study in Female Subjects With Breast Cancer Receiving Aromatase Inhibitor or Tamoxifen
A Phase 1 study testing oral capsule of Q-122 in people with Vasomotor Symptoms (VMS), run by Que Oncology.
Trial summary
Open-label, two dose study of Q-122, over a 4 week treatment period to explore the effects of Q-122 in a population of women with a history of breast cancer taking an aromatase inhibitor or tamoxifen. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Vasomotor Symptoms (VMS)
- What is being tested?
- oral capsule of Q-122
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2014to 28 Jul 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be a female of any race between the ages of 30-70 years.
- History of breast cancer and presently taking an aromatase inhibitor or tamoxifen.
- Naturally menopausal: ≥ 12 months spontaneous amenorrhea or > 6 but < 12 months amenorrhea with a serum follicle stimulating hormone (FSH) level of > 40 mIU/mL (Milli-international Units Per Milliliter).
- Surgically menopausal with an FSH level > 40 mIU/mL.
- Have a minimum of 7 moderate to severe hot flushes/day or 50 moderate to severe hot flushes per week, as verified for both weeks during the 14-day Screening Phase, prior to enrollment into the treatment phase of the study.
- Able to read, understand and complete the required subject diary.
- Willing and able to complete the daily subject diary, attend all study visits, and participate in all study procedures, including PK blood draws.
Who cannot join
- Childbearing potential, including pregnancy, or lactation.
- Undiagnosed abnormal genital bleeding.
- Significant day-to-day variability in hot flushes.
- Participation in another clinical trial within 30 days prior to screening or during the study.
- Legal incapacity or limited legal capacity.
- Chronic renal (serum creatinine > 2.0 mg/dL) or hepatic disease [SGPT (ALT) or SGOT (AST) > 2X normal limits].
Show all 18Show fewer
- Gastrointestinal, liver, kidney or other conditions which could interfere with the absorption, distribution, metabolism or excretion of Q-122.
- Untreated overt hyperthyroidism.
- Use of thyroid medication of less than 12 weeks on a stable dose.
- Any clinically important systemic disease in the judgement of the investigator.
- Inability to complete all study visits and study assessments for scheduling or other reasons.
- Any other reason which in the investigator's opinion makes the subject unsuitable for a clinical trial.
- Abnormal laboratory findings including:
- Hematocrit < 30% or hemoglobin < 9.5 gm/dL
- Fasting blood sugar > 140 mg/dL
- Fasting serum triglycerides > 300 mg/dL
- Fasting SGOT, SGPT, GGT, or bilirubin greater than twice the upper limit of normal (a subject will not be excluded if a second measurement is less than twice the upper limit of normal)
- Creatinine > 2.0 mg/dL
About this study
Official title: A Two Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Effect on Vasomotor Symptoms of Q-122 in Female Subjects With Breast Cancer and Receiving an Aromatase Inhibitor or Tamoxifen
Open-label, two dose study of Q-122, over a 4 week treatment period to explore the effects of Q-122 in a population of women with a history of breast cancer taking an aromatase inhibitor or tamoxifen.
Read the detailed description
Vasomotor symptoms 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 problematic especially if their therapeutic regime involves an aromatase inhibitor. Therefore, this study will explore the effect of Q-122 in a population of women with a history of breast cancer taking an aromatase inhibitor or tamoxifen.
The study is an open-label, two dose study (Group 1: 100 mg once daily and Group 2: 200 mg once daily) of Q-122, over a 4 week treatment period. As eligible subjects are enrolled, they will be assigned to Group 1 until Group 1 is fully enrolled. Dose escalation to the 200 mg level will only occur following a review of the safety experience of at least 6 subjects treated with 100 mg Q-122 once daily for at least 2 weeks. Once Group 1 is fully enrolled, eligible subjects will be enrolled into Group 2.
A two-week screening phase will be used to establish a stable baseline of vasomotor symptoms and to establish study eligibility. Qualified subjects will be treated with Q-122 for four weeks either at 100 mg/day dose or the 200 mg/day dose, during which time they will be evaluated for safety, tolerability, and pharmacokinetics of Q-122 and tamoxifen levels; subjects will continue to record their hot flashes in identical fashion to the screening period. Following the 28 day treatment, period subjects who complete the study will continue to record their hot flashes for a two week follow up period.
- Conditions
- Vasomotor Symptoms (VMS)
- Being tested
- oral capsule of Q-122
- Keywords
- Vasomotor Symptoms, Breast Cancer, Hot Flashes, Tamoxifen, Aromatase Inhibitors, Estrogen Antagonists, Hormone Antagonists, Hormones, Hormone Substitutes, Hormone Antagonists, Physiological Effects of Drugs, Antineoplastic Agents, Hormonal Antineoplastic, Selective Estrogen Receptor Modulators, Estrogen Receptor Modulators, Bone Density Conservation Agents, Steroid Synthesis Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
- Medical subject headings
- Breast Neoplasms, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral capsule of Q-122Drug
| Study group | Role | What they receive |
|---|---|---|
| 100 mg Q-122 | Experimental | 10 patients treated with Q-122, 100 mg. Dosage was 100 mg Q-122 administered orally as two 50 mg capsules once daily for 28 days. Receives: Drug: oral capsule of Q-122 |
| 200 mg Q-122 | Experimental | 11 patients treated with Q-122, 200 mg. Dosage was 200 mg Q-122 administered orally as four 50 mg capsules once daily for 28 days. Receives: Drug: oral capsule of Q-122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event (AE) Reporting of Q-122
Number of participants with indicated AE receiving Q-122
Measured: 4 weeks
Serious Adverse Event (SAE) Reporting of Q-122
Number of participants with indicated SAE receiving Q-122
Measured: 4 weeks
Change in Frequency of Moderate to Severe Vasomotor Symptoms.
Mean change in frequency of moderate to severe vasomotor symptoms. Daily patient (paper) diaries will be used as the primary efficacy collection tool. Change from baseline represents the mean change from the daily average frequency calculated at baseline to the daily average frequency calculated for the last week the subject was on drug. The hot flash severity categories are defined clinically as follow: mild, sensation of heat without perspiration; moderate, sensation of heat with perspiration, but subject is able to continue with activity; and severe. sensation of heat with sweating, sufficiently severe to result in discontinuation of activity.
Measured: Baseline to 4 weeks
Percent Change in Frequency of Moderate to Severe Vasomotor Symptoms.
Percent reduction in frequency of moderate to severe vasomotor symptoms. Daily patient (paper) diaries will be used as the primary efficacy collection tool. The hot flash severity categories are defined clinically as follows: mild, sensation of heat without perspiration; moderate, sensation of heat with perspiration, but subject is able to continue with activity; and severe, sensation of heat with sweating, sufficiently severe to result in discontinuation of activity.
Measured: Baseline to 4 weeks
Secondary outcomes (3)
Change in Hot Flash Severity Score
For moderate-to-severe (mod/sev) hot flashes (HF), a score will be calculated by multiplying the number of moderate-to-severe HFs by their severity to determine the HF (mod/sev) index score, using the following formula: HFSSmod/sev = (number of moderate hot flashes/day × 2) + (number of severe hot flashes/day x 3). The Average Daily HFSSmod/sev for each week will be calculated by dividing the total of daily HFSSmod/sev by the number of days observations will be recorded in that week. The change in score is of clinical significance, with a lower score representing less moderate to severe hot flashes and a higher score representing a greater number of moderate to severe hot flashes.
Measured: Baseline to 4 weeks
Percent Change in Hot Flash Severity Score
For moderate-to-severe (mod/sev) hot flashes (HF), a score will be calculated by multiplying the number of moderate-to-severe HFs by their severity to determine the HF (mod/sev) index score, using the following formula: HFSSmod/sev = (number of moderate hot flashes/day × 2) + (number of severe hot flashes/day x 3). The Average Daily HFSSmod/sev for each week will be calculated by dividing the total of daily HFSSmod/sev by the number of days observations will be recorded in that week.
Measured: Baseline to 4 weeks
Symptoms Associated With Postmenopausal Status
Greene Climacteric Scale: A comprehensive assessment divided into psychological, physical and vasomotor areas. The scale includes 21 symptoms, subject will score the severity of each symptom with the following score system: 0 = not at all; 1 = a little; 2 = quite a bit; and 3 = extremely. The results represent the total combined score, which can range from 0 to 63. A lower score represents a better outcome.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start10 Jan 2014
- Primary completion28 Jul 2014
- Study completion28 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vasomotor Symptoms (VMS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- open-label, two dose study
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Que Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rob Crombie, Study chair, Que Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080297
- Sponsor's protocol ID
- Q-1001
- Status last verified
- Feb 2020
- First submitted
- 20 Aug 2019
- Last updated
- 28 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Effect on Vasomotor Symptoms of Q-122 in Female Subjects With Breast Cancer and Receiving an Aromatase Inhibitor or Tamoxifen
- ClinicalTrials.gov ID
- NCT04080297
- Acronym / sponsor ID
- Q-1001
- Conditions
- Vasomotor Symptoms (VMS)
- Keywords
- Vasomotor Symptoms, Breast Cancer, Hot Flashes, Tamoxifen, Aromatase Inhibitors, Estrogen Antagonists, Hormone Antagonists, Hormones, Hormone Substitutes, Hormone Antagonists, Physiological Effects of Drugs, Antineoplastic Agents, Hormonal Antineoplastic, Selective Estrogen Receptor Modulators, Estrogen Receptor Modulators, Bone Density Conservation Agents, Steroid Synthesis Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Que OncologyIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2014 (actual)
- Primary completion
- 28 Jul 2014 (actual)
- Study completion
- 28 Jul 2014 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Posted 28 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, two dose study of Q-122, over a 4 week treatment period to explore the effects of Q-122 in a population of women with a history of breast cancer taking an aromatase inhibitor or tamoxifen.
Detailed description
Vasomotor symptoms 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 problematic especially if their therapeutic regime involves an aromatase inhibitor. Therefore, this study will explore the effect of Q-122 in a population of women with a history of breast cancer taking an aromatase inhibitor or tamoxifen.
The study is an open-label, two dose study (Group 1: 100 mg once daily and Group 2: 200 mg once daily) of Q-122, over a 4 week treatment period. As eligible subjects are enrolled, they will be assigned to Group 1 until Group 1 is fully enrolled. Dose escalation to the 200 mg level will only occur following a review of the safety experience of at least 6 subjects treated with 100 mg Q-122 once daily for at least 2 weeks. Once Group 1 is fully enrolled, eligible subjects will be enrolled into Group 2.
A two-week screening phase will be used to establish a stable baseline of vasomotor symptoms and to establish study eligibility. Qualified subjects will be treated with Q-122 for four weeks either at 100 mg/day dose or the 200 mg/day dose, during which time they will be evaluated for safety, tolerability, and pharmacokinetics of Q-122 and tamoxifen levels; subjects will continue to record their hot flashes in identical fashion to the screening period. Following the 28 day treatment, period subjects who complete the study will continue to record their hot flashes for a two week follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open-label, two dose study
| Arm | Type | Receives |
|---|---|---|
| 100 mg Q-122 | Experimental | Drug: oral capsule of Q-12210 patients treated with Q-122, 100 mg. Dosage was 100 mg Q-122 administered orally as two 50 mg capsules once daily for 28 days. |
| 200 mg Q-122 | Experimental | Drug: oral capsule of Q-12211 patients treated with Q-122, 200 mg. Dosage was 200 mg Q-122 administered orally as four 50 mg capsules once daily for 28 days. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be a female of any race between the ages of 30-70 years.
- History of breast cancer and presently taking an aromatase inhibitor or tamoxifen.
- Naturally menopausal: ≥ 12 months spontaneous amenorrhea or > 6 but < 12 months amenorrhea with a serum follicle stimulating hormone (FSH) level of > 40 mIU/mL (Milli-international Units Per Milliliter).
- Surgically menopausal with an FSH level > 40 mIU/mL.
- Have a minimum of 7 moderate to severe hot flushes/day or 50 moderate to severe hot flushes per week, as verified for both weeks during the 14-day Screening Phase, prior to enrollment into the treatment phase of the study.
Key exclusion criteria (18 listed)
- Childbearing potential, including pregnancy, or lactation.
- Undiagnosed abnormal genital bleeding.
- Significant day-to-day variability in hot flushes.
- Participation in another clinical trial within 30 days prior to screening or during the study.
- Legal incapacity or limited legal capacity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral capsule of Q-122 | Drug | 100 mg Q-122, 200 mg Q-122 |
Primary outcome
Adverse Event (AE) Reporting of Q-122
Time frame: 4 weeks
Number of participants with indicated AE receiving Q-122
Serious Adverse Event (SAE) Reporting of Q-122
Time frame: 4 weeks
Number of participants with indicated SAE receiving Q-122
Change in Frequency of Moderate to Severe Vasomotor Symptoms.
Time frame: Baseline to 4 weeks
Mean change in frequency of moderate to severe vasomotor symptoms. Daily patient (paper) diaries will be used as the primary efficacy collection tool. Change from baseline represents the mean change from the daily average frequency calculated at baseline to the daily average frequency calculated for the last week the subject was on drug. The hot flash severity categories are defined clinically as follow: mild, sensation of heat without perspiration; moderate, sensation of heat with perspiration, but subject is able to continue with activity; and severe. sensation of heat with sweating, sufficiently severe to result in discontinuation of activity.
Percent Change in Frequency of Moderate to Severe Vasomotor Symptoms.
Time frame: Baseline to 4 weeks
Percent reduction in frequency of moderate to severe vasomotor symptoms. Daily patient (paper) diaries will be used as the primary efficacy collection tool. The hot flash severity categories are defined clinically as follows: mild, sensation of heat without perspiration; moderate, sensation of heat with perspiration, but subject is able to continue with activity; and severe, sensation of heat with sweating, sufficiently severe to result in discontinuation of activity.
3 secondary outcomes
Change in Hot Flash Severity Score
Time frame: Baseline to 4 weeks
Percent Change in Hot Flash Severity Score
Time frame: Baseline to 4 weeks
Symptoms Associated With Postmenopausal Status
Time frame: Baseline and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Vasomotor Symptoms (VMS)
Not yet recruiting
Waning Moon: A Whole Person Health Intervention Designed by and for Urban Menopausal American Indian/Alaska Native Women
Menopause, Vasomotor Symptoms (VMS)
RecruitingPhase 2
Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).
Vasomotor Symptoms
Not yet recruitingObservational study
An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Symptoms in United States
Vasomotor Symptoms (VMS) Associated With Menopause
Not yet recruiting
ROSA-B: ALAN Exposure and Brain Health in Midlife Women With VMS
Women in the Menopausal Period
Recruiting
Impact of Lean Pork on Endothelial Function in Perimenopause
Cardiovascular Outcome, Overweight and Obese Women
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob Crombie study chair
Que Oncology
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing oral capsule of Q-122 in people with Vasomotor Symptoms (VMS), run by Que Oncology.
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 18 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 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adverse Event (AE) Reporting of Q-122 (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2020.