Effect of Amgen Investigational Product on Cellular Biomarkers in the Human Breast
Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteer, Female, Breast
Intervention: No treatment (Other); Denosumab - low dose (Drug); Denosumab - high dose (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s): MD, Study Director, Affiliation: Amgen
Summary
This study plans to enroll 72 healthy female volunteers. Subjects will be randomized into 1
of 3 treatment arms. The impact of the Investigational Prodcuct on relevant cellular
biomarkers in the human breast will be evaluated.
Clinical Details
Official title: A Randomized, Stratified, Open-label, No-treatment-controlled, Parallel Group, Multicenter Phase 1 Trial to Evaluate the Effect of Denosumab on Cellular Proliferation in the Human Breast
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Ratio of post-baseline to baseline Ki-67 index
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
INCLUSION CRITERIA:
- Willing to use, in combination with her partner, 2 non-hormonal methods of effective
contraception or practice sexual abstinence. Subjects who are surgically sterile (eg,
history of hysterectomy) or whose sexual partner is sterile (eg, history of
vasectomy) are not required to use contraceptive measures
- Laboratory tests are within clinically acceptable range
- Clinically acceptable physical exam and no history or evidence of any clinically
significant medical disorder that would pose a risk to subject safety or interfere
with study evaluations or procedures.
EXCLUSION CRITERIA:
- Female subject with a prior history of breast cancer; Breast implant in the breast to
be biopsied; Known history of fibrocystic breast disease
- Subject is unable or unwilling to provide breast biopsy tissue from the upper outer
quadrant of her breast
- Pregnant or plans to become pregnant while exposed to investigational product
- Lactating/breastfeeding or plans to breastfeed while exposed to investigational
product
- Recent use of any non-approved medications or devices
- Uncontrolled thyroid disorder
- Significant dental/oral disease
- Planned invasive dental procedures
- Positive urine screen for alcohol and/or drugs
Locations and Contacts
Research Site, Cypress, California 90630, United States
Research Site, Hollywood, Florida 33024, United States
Research Site, Miami, Florida 33143, United States
Additional Information
AmgenTrials clinical trials website
Starting date: April 2014
Last updated: March 7, 2015
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