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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PF-06804103 		Study Treatment
  • Drug: PF-06804103
    Dose Escalation Part - 1A Dose Expansion Part - 2A
  • Drug: PF-06804103 + Palbociclib +Letrozole
    Dose Escalation - Part 1B Dose Expansion - Part 2B
Experimental
PF-06804103+Combination Regimen 		Study Treatment
  • Drug: PF-06804103 + Palbociclib +Letrozole
    Dose Escalation - Part 1B Dose Expansion - Part 2B

More Details

Status
Completed
Sponsor
Pfizer

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.