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Tracking Information | |||||
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First Received Date † | September 17, 2004 | ||||
Last Updated Date | July 31, 2008 | ||||
Start Date † | August 2004 | ||||
Current Primary Outcome Measures † |
To evaluate the safety and PK of 2 dose schedules of panitumumab in subjects with advanced solid tumors, refractory to or with no available standard therapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00091806 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
To asses the immunogenicity and efficacy of 2 dose schedules of panitumumab in subjects with advanced solid tumors. [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors | ||||
Official Title † | An Open-Label, Clinical Trial Evaluating the Safety and Pharmacokinetics of Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors | ||||
Brief Summary | The purpose of this study is to evaluate the safety and pharmacokinetics of two dose schedules of panitumumab in subjects with advanced solid tumors. |
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Detailed Description | |||||
Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study | ||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 86 | ||||
Completion Date | October 2006 | ||||
Primary Completion Date | April 2006 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00091806 | ||||
Responsible Party | Global Development Leader, Amgen Inc. | ||||
Secondary IDs †† | |||||
Study Sponsor † | Amgen | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Amgen | ||||
Verification Date | July 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |