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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 : April 9, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2005
Primary Completion Date : April 2007
Study Completion Date : September 2010
Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Contacts and Locations

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
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90095
Pfizer Investigational Site
Santa Monica, California, United States, 90404
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Netherlands
Pfizer Investigational Site
Amsterdam, Netherlands, 1066 CX
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00225121     History of Changes
Obsolete Identifiers: NCT00276653, NCT00278291
Other Study ID Numbers: A7471001
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: April 9, 2012
Last Verified: April 2012