Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
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 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.

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 and Negative Solid Tumors

Keywords

Breast Neoplasms HER2 PF-06804103 ADC breast cancer neoplasms solid tumors human epidermal growth receptor 2 Letrozole Palbociclib PF-06804103 + Palbociclib +Letrozole

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 (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 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