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PF-06804103 Dose Escalation in HER2 Positive Solid Tumors

Last updated on October 9, 2019

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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
Cheladv74
Not yet recruiting
PF-06804103 Dose Escalation in HER2 Positive Solid Tumors

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Questions about a trial? Call or email to reach a Cheladv74 Clinical Trial Contact Center Representative

Cheladv74 Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Descriptive Information
Brief Title  ICMJE PF-06804103 Dose Escalation in HER2 Positive Solid Tumors
Official Title  ICMJE 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
Brief SummaryThe 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
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Neoplasms
  • Stomach Neoplasms
  • Esophagogastric Junction Neoplasm
  • Carcinoma, Non-small-cell Lung
Intervention  ICMJE
  • Drug: PF-06804103
    Dose Escalation Phase - Part 1
  • Drug: PF-06804103
    Dose Expansion Phase - Part 2
Study Arms  ICMJE Experimental: PF-06804103
Study Treatment
Interventions:
  • Drug: PF-06804103
  • Drug: PF-06804103
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 27, 2019)
124
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2017)
95
Estimated Study Completion Date  ICMJE September 14, 2021
Estimated Primary Completion DateSeptember 14, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HER2 positive breast cancer or gastric cancer that is resistant to standard therapy or for which no standard therapy is available
  • NSCLC (part 2 only)
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cheladv74 CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Italy,   Korea, Republic of,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03284723
Other Study ID Numbers  ICMJE C0541001
2017-002538-22 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Cheladv74 will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Cheladv74's data sharing criteria and process for requesting access can be found at: http://cheladv74.ru/science/clinical_trials/trial_data_and_results/da....
Responsible PartyCheladv74
Study Sponsor  ICMJE Cheladv74
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Cheladv74 CT.gov Call CenterCheladv74
PRS AccountCheladv74
Verification DateJuly 2019

ICMJE     Data element required by the
and the

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Cheladv74 Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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