First In Human, Phase 1 Study of AG013736 In Patients With Solid Tumors
NCT01469052
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- Patients with cytologically or histologically confirmed solid tumor(s) and with at least one measurable disease site
- Patients with adequate bone marrow, liver and kidney function
- Patients with life expectancy of at least 12 weeks
- Patients who have received chemotherapy, immunotherapy, radiotherapy or any
investigational agent within 4 weeks of study entry
- Patients with have had a major surgical procedure within 4 weeks of study entry
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Descriptive Information | ||||
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Brief Title ICMJE | First In Human, Phase 1 Study of AG013736 In Patients With Solid Tumors | |||
Official Title ICMJE | Phase I, Open-Label, Multicenter, Dose-Escalation Study Of The Tyrosine Kinase Inhibitor Of VEGFR-2, AG013736, In Patients With Advanced Solid Tumors | |||
Brief Summary | The purpose of the study was to characterize the safety of investigational agent AG-013736, in patients with solid tumors in this First In Human trial. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Advanced Solid Tumors | |||
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 | Completed | |||
Actual Enrollment ICMJE | 36 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | August 2004 | |||
Actual Primary Completion Date | July 2004 (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 | NCT01469052 | |||
Other Study ID Numbers ICMJE | AG013736-001 A4060010 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | February 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |