A Study Of PF-06263507 In Patients With Advanced Solid Tumors
NCT01891669
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- Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for which no standard therapy is available.
- Performance Status of 0 or 1.
- Adequate bone marrow, kidney, liver, and heart function.
- Brain metastases requiring steroids.
- Major surgery or anti-cancer therapy within 4 weeks of study treatment start.
- Active bacterial, fungal or viral infection.
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Descriptive Information | |||||
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Brief Title ICMJE | A Study Of PF-06263507 In Patients With Advanced Solid Tumors | ||||
Official Title ICMJE | A PHASE 1, DOSE ESCALATION STUDY OF PF-06263507 IN PATIENTS WITH ADVANCED SOLID TUMORS | ||||
Brief Summary | To assess the safety and tolerability at increasing dose levels of PF-06263507 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Part 1
Interventions:
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Publications * | Shapiro GI, Vaishampayan UN, LoRusso P, Barton J, Hua S, Reich SD, Shazer R, Taylor CT, Xuan D, Borghaei H. First-in-human trial of an anti-5T4 antibody-monomethylauristatin conjugate, PF-06263507, in patients with advanced solid tumors. Invest New Drugs. 2017 Jun;35(3):315-323. doi: 10.1007/s10637-016-0419-7. Epub 2017 Jan 9. | ||||
* 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 | Terminated | ||||
Actual Enrollment ICMJE | 26 | ||||
Original Estimated Enrollment ICMJE | 75 | ||||
Actual Study Completion Date ICMJE | June 29, 2015 | ||||
Actual Primary Completion Date | June 29, 2015 (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 | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01891669 | ||||
Other Study ID Numbers ICMJE | B4481001 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
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 | December 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |