Status:
TERMINATED
PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors
Lead Sponsor:
Pfizer
Conditions:
Breast Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2021
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT03284723
Start Date
November 1 2017
End Date
August 31 2021
Last Update
September 3 2024
Active Locations (46)
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1
Banner-University Medical Center Tucson
Tucson, Arizona, United States, 85719
2
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States, 85719
3
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
4
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048