Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion:

Description

Summary

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive solid tumors. The study will expand to look at the selected dose in patients with breast cancer, gastric cancer and non-small cell lung cancer

Official Title

A Phase 1 Dose Escalation Study Evaluating The Safety And Tolerability Of Pf-06804103 In Patients With Human Epidermal Growth Factor Receptor 2 (her2) Positive Solid Tumors

Keywords

Breast Neoplasms Stomach Neoplasms Esophagogastric Junction Neoplasm Carcinoma, Non-small-cell Lung HER2 PF-06804103 ADC breast cancer gastric cancer esophagogastric cancer non-small cell lung cancer neoplasms solid tumors human epidermal growth receptor 2

Eligibility

You can join if…

Open to people ages 18 years and up

  • HER2 positive breast cancer or gastric cancer that is resistant to standard therapy or for which no standard therapy is available
  • Performance status of 0 or 1
  • Adequate bone marrow, kidney and liver function

You CAN'T join 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

Locations

  • (IRB#17-001086) Ronald Reagan UCLA Medical Center, Drug Information Center accepting new patients
    Los Angeles California 90095 United States
  • UCLA Hematology/Oncology accepting new patients
    Los Angeles California 90095 United States
  • Santa Monica - UCLA Medical Center and Orthopaedic Hospital accepting new patients
    Santa Monica California 90404 United States
  • UCLA Dept of Medicine - Hematology/Oncology, Santa Monica accepting new patients
    Santa Monica California 90404 United States
  • UCLA Hematology/Oncology - Santa Monica accepting new patients
    Santa Monica California 90404 United States
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute accepting new patients
    Los Angeles California 90048 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT03284723
Phase
Phase 1
Study Type
Interventional
Last Updated