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Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-00299804 In Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00225121
First received: September 21, 2005
Last updated: April 6, 2012
Last verified: April 2012

September 21, 2005
April 6, 2012
October 2005
April 2007   (final data collection date for primary outcome measure)
Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Safety
Complete list of historical versions of study NCT00225121 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Pharmacodynamics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Pharmacokinetics Pharmacodynamics Efficacy
Not Provided
Not Provided
 
Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-00299804 In Patients With Advanced Solid Tumors
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

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
Drug: PF-00299804
investigational drug by oral route (escalating doses depending on safety) administered until progression
Experimental: 1
open label single arm trial
Intervention: Drug: PF-00299804
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. doi: 10.1158/1078-0432.CCR-10-1220. Epub 2011 Jan 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
September 2010
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Malignant solid tumor for which there is no currently approved treatment
  • Adequate bone marrow, liver, cardiac, and kidney function

Exclusion Criteria:

  • Cardiac disease
  • Anticancer therapy within 4-6 weeks (depending on therapy)
  • Pregnant or breast-feeding
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Netherlands
 
NCT00225121
A7471001
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP