A Study of PF-04217903 in Patients With Advanced Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00706355

Purpose

PF-04217903 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-04217903 is a new member in a class of drugs called c-Met/hepatocyte growth factor receptor tyrosine kinase inhibitors. This research study is the first time PF-04217903 will be given to patients. PF-04217903 is taken by mouth daily.

Condition	Intervention	Phase
Neoplasms	Drug: PF-04217903	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Study of PF-4217903 in Patients With Advanced Cancer

Further study details as provided by Pfizer:

Primary Outcome Measures:

To test the safety of PF-04217903 when taken by people who have cancer [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To assess how the body handles blood concentrations of PF-04217903 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To find the dose of PF-04217903 that should be used in future clinical trials [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	August 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: PF-04217903 Escalating doses of PF-04217903 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 50 mg BID to 1000 mg BID. A cycle is considered to be 21 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Advanced solid tumors, histologically proven at diagnosis which is refractory to standard of care or for whom no standard of care therapy is available
Adequate blood cell counts, normal kidney function, and performance status of 0 or 1

Exclusion Criteria:

Major surgery, radiation therapy or anti-cancer therapy within 2 weeks of starting study treatment
Prior stem cell transplant
Active or unstable cardiac disease or heart attack within 12 months of starting study treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706355

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations

United States, Colorado
Pfizer Investigational Site	Not yet recruiting
Aurora, Colorado, United States, 80045
United States, Illinois
Pfizer Investigational Site	Recruiting
Chicago, Illinois, United States, 60637
United States, Massachusetts
Pfizer Investigational Site	Recruiting
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site	Recruiting
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site	Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Pfizer Investigational Site	Recruiting
Detroit, Michigan, United States, 48201

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B0331002
Study First Received:	June 25, 2008
Last Updated:	January 4, 2009
ClinicalTrials.gov Identifier:	NCT00706355
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009