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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: PF-00299804 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 11, 2005
Actual Primary Completion Date : April 3, 2007
Actual Study Completion Date : September 23, 2010

Arm Intervention/treatment
Experimental: 1
open label single arm trial
Drug: PF-00299804
investigational drug by oral route (escalating doses depending on safety) administered until progression




Primary Outcome Measures :
  1. Safety [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 6 months ]
  2. Pharmacodynamics [ Time Frame: 6 months ]
  3. Efficacy [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225121


Locations
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United States, California
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
UCLA Hematology/Oncology
Los Angeles, California, United States, 90095
UCLA Oncology Center
Los Angeles, California, United States, 90095
UCLA Hematology Oncology - Santa Monica
Santa Monica, California, United States, 90404
UCLA Santa Monica Hematology/Oncology
Santa Monica, California, United States, 90404
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Netherlands
Vereniging het Nederlandse Kanker Instituut
Amsterdam, Netherlands, 1066 CX
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00225121    
Obsolete Identifiers: NCT00276653, NCT00278291
Other Study ID Numbers: A7471001
2005-001140-23 ( EudraCT Number )
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
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.