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PF-06804103 Dose Escalation in HER2 Positive Solid Tumors

Last updated on July 5, 2018

FOR MORE INFORMATION
Study Location
Banner- University Medical Center Tucson Campus LLC
Tucson, Arizona, 85719 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms, Stomach Neoplasms, Esophagogastric Junction Neoplasm, Non-small-cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

- Patients with previous history or active interstitial lung disease or pulmonary
fibrosis, or a history of other clinically significant lung diseases

NCT03284723
Pfizer
Recruiting
PF-06804103 Dose Escalation in HER2 Positive Solid Tumors

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PF-06804103 Dose Escalation in HER2 Positive Solid Tumors
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
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
Not Provided
Interventional
Phase 1
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Neoplasms
  • Stomach Neoplasms
  • Esophagogastric Junction Neoplasm
  • Carcinoma, Non-small-cell Lung
  • Drug: PF-06804103
    Dose Escalation Phase - Part 1
  • Drug: PF-06804103
    Dose Expansion Phase - Part 2
Experimental: PF-06804103
Study Treatment
Interventions:
  • Drug: PF-06804103
  • Drug: PF-06804103
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
95
August 19, 2020
August 19, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03284723
C0541001
2017-002538-22 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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