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A Phase 1b/2 Randomized Study of MEDI-573 in Combination With an Aromatase Inhibitor (AI) Versus AI Alone in Women With Metastatic Breast Cancer (MBC)


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer

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Trial Information

A Phase 1b/2 Randomized Study of MEDI-573 in Combination With an Aromatase Inhibitor (AI) Versus AI Alone in Women With Metastatic Breast Cancer (MBC)


Inclusion Criteria:



- Histologically-confirmed MBC not deemed amenable to curative surgery or curative
radiation therapy

- Tumors are positive for ER, PgR, or both

- Tumors must be negative for HER2 (by FISH, CISH or IHC)

- Female gender and age ≥ 18 years at time of study entry

- Postmenopausal

- Karnofsky Performance Status ≥ 70

- Life expectancy of ≥ 6 months

Exclusion Criteria:

- Subjects who received prior chemotherapy, hormonal therapy, immunotherapy or biologic
therapy for advanced or metastatic disease with the following exceptions:

- Prior adjuvant therapy with an AI and/or tamoxifen is allowed, provided
treatment ended at least 2 weeks prior to the first dose of MEDI-573

- Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed

- Extensive symptomatic visceral disease including hepatic involvement and pulmonary
lymphangitic spread of tumor, or disease that is considered by the investigator to be
rapidly progressing or life threatening (eg, subjects who are intended for
chemotherapy)

- Active brain metastases with the exception of subject has been treated and are
asymptomatic and there has been no evidence of CNS progression for at least 4 weeks
of first dose of MEDI-573

- Evidence of ongoing spinal cord compression or leptomeningeal carcinomatosis

- Unresolved toxicities from prior therapy with the exception of alopecia that have not
resolved to ≤ Grade 1 at the time of starting study treatment

- Previous treatment with agents that target the IGF receptor

- History of allergy or reaction attributed to compounds of chemical or biologic
composition similar to those of MEDI-573 or AI

- History of another invasive malignancy within 5 years except for curatively resected
nonmelanoma skin cancer or carcinoma in situ of the cervix

- Poorly controlled diabetes mellitus

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase Ib: Safety and tolerability of 2 dose levels of MEDI-573 combined with AI

Outcome Description:

The primary objective of the dose-evaluation phase is to evaluate the safety and tolerability of 3 dose levels of MEDI 573 in combination with an AI in subjects with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative MBC. Specific endpoints: number of subjects with AEs, SAEs, and DLTs.

Outcome Time Frame:

5 months

Safety Issue:

Yes

Principal Investigator

Jennifer McDevitt, PharmD, Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

MedImmune LLC

Authority:

United States: Food and Drug Administration

Study ID:

CD-ON-MEDI-573-1030

NCT ID:

NCT01446159

Start Date:

June 2011

Completion Date:

August 2015

Related Keywords:

  • Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer
  • MEDI-573, breast cancer, metastatic, aromatase inhibitor, anti-IGF
  • Breast Neoplasms

Name

Location

Research SiteMesa, Arizona  
Research SiteAnaheim, California  
Research SiteDanbury, Connecticut  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteBangor, Maine  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteAlexandria, Minnesota  
Research SiteGrand Island, Nebraska  
Research SiteBelleville, New Jersey  
Research SiteAlbuquerque, New Mexico  
Research SiteAlbany, New York  
Research SiteAkron, Ohio  
Research SiteAllentown, Pennsylvania  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteAbington, Virginia