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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral capsule of Q-122 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event (AE) Reporting of Q-122 | Number of participants with indicated AE receiving Q-122 | 4 weeks |
| Serious Adverse Event (SAE) Reporting of Q-122 | Number of participants with indicated SAE receiving Q-122 | 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. | 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. | Baseline to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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].
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:
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| Name | Affiliation | Role |
|---|---|---|
| Rob Crombie | Que Oncology | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | 100 mg Q-122 | Dosage was 100 mg Q-122 administered orally as two 50 mg capsules once daily for 28 days. |
| FG001 | 200 mg Q-122 | Dosage was 200 mg Q-122 administered orally as four 50 mg capsules once daily for 28 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 100 mg Q-122 | Dosage was 100 mg Q-122 administered orally as two 50 mg capsules once daily for 28 days. |
| BG001 | 200 mg Q-122 | Dosage was 200 mg Q-122 administered orally as four 50 mg capsules once daily for 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Event (AE) Reporting of Q-122 | Number of participants with indicated AE receiving Q-122 | Analyses were performed using the results from the safety analysis population. | Posted | Count of Participants | Participants | 4 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 100 mg Q-122 | Dosage was 100 mg Q-122 administered orally as two 50 mg capsules once daily for 28 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast pain | Reproductive system and breast disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aspartate aminotransferase increase | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rob Crombie | Chief Exceutive Officer | +61 3 9657 0731 | rcrombie@queoncology.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C573792 | N,N'-(1,4-phenylenebis(methylene))dipyrimidin-2-amine |
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open-label, two dose study
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| 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. | 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. | Baseline and 4 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Serious Adverse Event (SAE) Reporting of Q-122 | Number of participants with indicated SAE receiving Q-122 | Analyses were performed using the results from the safety analysis population. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Primary | 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. | Analyses were performed using the intent-to-treat (ITT) population. | Posted | Mean | Standard Deviation | Hot flashes/day | Baseline to 4 weeks |
|
|
|
| Primary | 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. | Analyses were performed using the intent-to-treat (ITT) population. | Posted | Mean | Standard Deviation | Percent change | Baseline to 4 weeks |
|
|
|
| Secondary | 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. | Analyses were performed using the intent-to-treat (ITT) population. The ITT population was defined as all subjects who received at least one dose of study medication and have an evaluable primary or secondary efficacy measurement after baseline. | Posted | Mean | Standard Deviation | Hot flash severity score (HFSS)/day | Baseline to 4 weeks |
|
|
|
| Secondary | 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. | Analyses were performed using the intent-to-treat (ITT) population. | Posted | Mean | Standard Deviation | Percent change | Baseline to 4 weeks |
|
|
|
| Secondary | 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. | Analyses were performed using the intent-to-treat (ITT) population. The ITT population was defined as all subjects who received at least one dose of study medication and had an evaluable primary or secondary efficacy measurement after baseline. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 4 weeks |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 7 |
| 10 |
| EG001 | 200 mg Q-122 | Dosage was 200 mg Q-122 administered orally as four 50 mg capsules once daily for 28 days. | 0 | 11 | 1 | 11 | 7 | 11 |
| Blood thyroid stimulating hormone increased | Investigations | Systematic Assessment |
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| Blood triglycerides increased | Investigations | Systematic Assessment |
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| Blood uric acid increased | Investigations | Systematic Assessment |
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| Weight increased | Investigations | Systematic Assessment |
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| Coordination abnormal | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Insomnia | Nervous system disorders | Systematic Assessment |
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| Gastroenteritis viral | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Oral herpes | Gastrointestinal disorders | Systematic Assessment |
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| Contusion | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Euphoric mood | Psychiatric disorders | Systematic Assessment |
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| Flank pain | General disorders | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | Systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | Systematic Assessment |
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| Breast mass | Reproductive system and breast disorders | Systematic Assessment |
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| Vulvovaginal burning sensation | Reproductive system and breast disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Change from baseline |
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| Treatment - Week 1 |
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| Treatment - Week 2 |
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| Treatment - Week 3 |
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| Treatment - Week 4 |
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| Total Score - 4 weeks |
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