Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-00299804 In Patients With Advanced Solid Tumors
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00225121
First received: September 21, 2005
Last updated: April 6, 2012
Last verified: April 2012
| Tracking Information | |||||
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| First Received Date ICMJE | September 21, 2005 | ||||
| Last Updated Date | April 6, 2012 | ||||
| Start Date ICMJE | October 2005 | ||||
| Primary Completion Date | April 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Safety | ||||
| Change History | Complete list of historical versions of study NCT00225121 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Pharmacokinetics Pharmacodynamics Efficacy | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-00299804 In Patients With Advanced Solid Tumors | ||||
| Official Title ICMJE | A Phase 1 Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of 2 Dosing Schedules Of PF-00299804 In Patients With Advanced Malignant Solid Tumors | ||||
| Brief Summary | The primary purpose of this study is to study the side effects of PF-00299804 and determine the highest dose that can be safely administered in patients with advanced cancer. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Neoplasms | ||||
| Intervention ICMJE | Drug: PF-00299804
investigational drug by oral route (escalating doses depending on safety) administered until progression |
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| Study Arm (s) | Experimental: 1
open label single arm trial
Intervention: Drug: PF-00299804 |
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| Publications * | Jänne PA, Boss DS, Camidge DR, Britten CD, Engelman JA, Garon EB, Guo F, Wong S, Liang J, Letrent S, Millham R, Taylor I, Eckhardt SG, Schellens JH. Phase I dose-escalation study of the pan-HER inhibitor, PF299804, in patients with advanced malignant solid tumors. Clin Cancer Res. 2011 Mar 1;17(5):1131-9. Epub 2011 Jan 10. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 121 | ||||
| Completion Date | September 2010 | ||||
| Primary Completion Date | April 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00225121 | ||||
| Other Study ID Numbers ICMJE | A7471001 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Pfizer | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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