PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors
NCT03284723
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- 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
- 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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Descriptive Information | |||||
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Brief Title ICMJE | PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) 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 and Negative Solid Tumors | ||||
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 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE | Breast Neoplasms | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | 148 | ||||
Original Estimated Enrollment ICMJE | 95 | ||||
Estimated Study Completion Date ICMJE | February 11, 2024 | ||||
Estimated Primary Completion Date | February 11, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Australia, Italy, Korea, Republic of, Russian Federation, 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 Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |