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PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors

Trial Status: Active

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2 positive only and gastric were studied in Part 1A only). The study will expand to look at selected doses in patients with HER2 positive and negative breast cancer.

Inclusion Criteria

  • HER2 positive breast cancer or gastric cancer that is resistant to standard therapy or for which no standard therapy is available (Part 1A only)
  • HER2 positive and negative breast cancer (Part 2A)
  • HER2 negative breast cancer (Part 1B & Part 2B)
  • Performance status of 0 or 1
  • Adequate bone marrow, kidney and liver function

Exclusion Criteria

  • Known CNS disease including, but not limited to, metastases
  • History of exposure to certain cumulative doses of anthracyclines
  • Grade 3 or higher hypersensitivity reaction to prior receipt of any antibody therapy
  • Active and clinically significant bacterial, fungal, or viral infection
  • Abnormal cardiac function defined by a LVEF <50% by ECHO or MUGA
  • Patients with previous history or active interstitial lung disease or pulmonary fibrosis, or a history of other clinically significant lung diseases

Arizona

Tucson
Banner University Medical Center - Tucson
Status: ACTIVE
Contact: Dana Lewallen
Phone: 520-626-2175

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Rose Estrada
Phone: 310-633-8400

Illinois

Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL

Kansas

Kansas City
University of Kansas Cancer Center
Status: IN_REVIEW

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Nancy S. Tait
Phone: 410-328-3546
Email: ntait@umm.edu

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: COMPLETED

Texas

Houston
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Pfizer Inc

  • Primary ID C0541001
  • Secondary IDs NCI-2017-02036, 2017-002538-22
  • Clinicaltrials.gov ID NCT03284723