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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

Page last updated: August 23, 2015

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