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

  • STATUS
    Recruiting
  • End date
    Nov 4, 2023
  • participants needed
    148
  • sponsor
    Pfizer
Updated on 29 November 2020
Investigator
Pfizer CT.gov Call Center
Primary Contact
Macquarie University (1.3 mi away) Contact
+50 other location
cancer
breast cancer
HER2
erbb2
palbociclib
her2/neu-positive breast cancer
letrozole

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.

Details
Treatment PF-06804103, PF-06804103 + Palbociclib +Letrozole
Clinical Study IdentifierNCT03284723
SponsorPfizer
Last Modified on29 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Esophagogastric Junction Neoplasm or Breast Cancer or Non-Small Cell Lung Cancer or Gastric Cancer or Stomach Cancer?
Do you have any of these conditions: breast tumor or Gastric Cancer or Stomach Cancer or Non-Small Cell Lung Cancer or Breast Cancer or Esophagogastric Junction Neoplasm or breast tumors ...?
Do you have any of these conditions: breast tumors or tumor of the breast or breast tumor or Esophagogastric Junction Neoplasm or Stomach Cancer or Gastric Cancer or Non-Small Cell Lung C...?
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
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