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Trial record 1 of 1 for:    NCT00225121
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Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-00299804 In Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00225121
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 21, 2005
First Posted Date  ICMJE September 23, 2005
Last Update Posted Date December 21, 2018
Actual Study Start Date  ICMJE October 11, 2005
Actual Primary Completion Date April 3, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Safety [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2005)
Safety
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
  • Pharmacokinetics [ Time Frame: 6 months ]
  • Pharmacodynamics [ Time Frame: 6 months ]
  • Efficacy [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2005)
Pharmacokinetics Pharmacodynamics Efficacy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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, OPEN-LABEL, DOSE-ESCALATION STUDY TO EVALUATE 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.
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 Neoplasms
Intervention  ICMJE Drug: PF-00299804
investigational drug by oral route (escalating doses depending on safety) administered until progression
Study Arms  ICMJE Experimental: 1
open label single arm trial
Intervention: Drug: PF-00299804
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. 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2012)
121
Original Enrollment  ICMJE
 (submitted: September 21, 2005)
50
Actual Study Completion Date  ICMJE September 23, 2010
Actual Primary Completion Date April 3, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (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 Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00225121
Other Study ID Numbers  ICMJE A7471001
2005-001140-23 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
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