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

Stopped early · Phase 1

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT03284723

Run by

Pfizer

People needed

95

Starts

2017-11-01

Expected to finish

2021-08-31

Last updated by the study team

2024-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner-University Medical Center Tucson — Tucson, Arizona, United States
• The University of Arizona Cancer Center - North Campus — Tucson, Arizona, United States
• The University of Arizona Cancer Center — Tucson, Arizona, United States
• Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute — Los Angeles, California, United States
• UCLA Health (main campus) — Los Angeles, California, United States
• UCLA Hematology/Oncology — Los Angeles, California, United States
• Santa Monica - UCLA Medical Center and Orthopaedic Hospital — Santa Monica, California, United States
• UCLA Dept of Medicine - Hematology/Oncology, Santa Monica — Santa Monica, California, United States
• UCLA Health, Santa Monica — Santa Monica, California, United States
• Northside Hospital Inc.- GCS/Athens — Athens, Georgia, United States
• Atlanta Cancer Care - Atlanta — Atlanta, Georgia, United States
• Northside Hospital, Inc. - GCS/Northside — Atlanta, Georgia, United States
• Northside Hospital — Atlanta, Georgia, United States
• Northside Hospital,Inc.-GCS /Blairsville — Blairsville, Georgia, United States
• Northside Hospital, Inc. - GCS/Canton — Canton, Georgia, United States
• Atlanta Cancer Care - Cumming — Cumming, Georgia, United States
• Northside Hospital, Inc.-GCS/Stemmer — Decatur, Georgia, United States
• Suburban Hematology-Oncology Associates - Duluth — Duluth, Georgia, United States
• Atlanta Cancer Care - Lake Spivey — Jonesboro, Georgia, United States
• Suburban Hematology-Oncology Associates- Lawrenceville — Lawrenceville, Georgia, United States
• Northside Hospital, Inc. - GCS/Macon — Macon, Georgia, United States
• Northside Hospital, Inc. GCS/Kennestone — Marietta, Georgia, United States
• Oncology Hematology West, PC dba Nebraska Cancer Specialists — Omaha, Nebraska, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Utah, Huntsman Cancer Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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