Dose Escalation Study in Female Subjects With Breast Cancer Receiving Aromatase Inhibitor or Tamoxifen

NCT04080297 | Completed Phase 1 Results FDA Drug

• 1 other identifier: Q-1001
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief 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.

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

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (3)

• Change in Hot Flash Severity Score

  Baseline to 4 weeks

• Percent Change in Hot Flash Severity Score

  Baseline to 4 weeks

• Symptoms Associated With Postmenopausal Status

  Baseline and 4 weeks

Study Arms (2)

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.

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.

Drug: oral capsule of Q-122

Interventions

oral capsule of Q-122 DRUG

100 mg Q-122; 200 mg Q-122

Eligibility Criteria

• Age: 30 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Hematocrit \< 30% or hemoglobin \< 9.5 gm/dL
• Fasting blood sugar \> 140 mg/dL

Sponsors & Collaborators

• Que Oncology: lead

MeSH Terms

Conditions

Breast Neoplasms; Hot Flashes

Interventions

N,N'-(1,4-phenylenebis(methylene))dipyrimidin-2-amine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Rob Crombie
• Organization: Chief Exceutive Officer

rcrombie@queoncology.com

+61 3 9657 0731

Study Officials

• Rob Crombie

  Que Oncology

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open-label, two dose study

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: September 6, 2019
• Study Start: January 10, 2014
• Primary Completion: July 28, 2014
• Study Completion: July 28, 2014
• Last Updated: February 28, 2020
• Results First Posted: February 28, 2020

Record last verified: 2020-02