Phase 1 Study Of Aurora Kinase Inhibitor PF-03814735 In Patients With Advanced Solid Tumors - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00424632

Purpose

The purpose of this study is to determine the maximum tolerated dose and recommended phase 2 dose of PF-03814735 administered orally as single agent in patients with advanced solid tumors.

Condition	Intervention	Phase
Solid Tumors	Drug: PF-03814735	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Gelatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A Phase 1, Open Label, Multi-Center, Accelerated Dose-Escalation, Pharmacokinetic And Pharmacodynamic Trial Of The Oral Single Agent Aurora Kinase Inhibitor PF-03814735 In Patients With Advanced Solid Tumors For Whom No Standard Therapy Is Available

Further study details as provided by Pfizer:

Primary Outcome Measures:

Overall safety profile of PF-03814735 as characterized by type, frequency, severity, and relationship to study drug of adverse events and laboratory abnormalities in the first and the following cycles [ Time Frame: first and subsequent cycles ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Objective tumor response as measured using the RECIST Criteria every 2 cycles [ Time Frame: first cycle ] [ Designated as safety issue: No ]
Tumor metabolism assessed by FDG-PET at cycle 1 [ Time Frame: every 2 cycles ] [ Designated as safety issue: No ]
Serum and urine pharmacokinetics parameters at different time points during cycle 1 [ Time Frame: first cycle ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	November 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single arm dose escalation: Experimental	Drug: PF-03814735 1, 5, and 25 mg gelatin capsules administered orally once a day from day 1 to day 5, or from day 1 to day 10 every 3 weeks until disease progression or unacceptable toxicity.

Eligibility

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

Criteria

Inclusion Criteria:

Metastatic solid tumor resistant to standard therapy or for which no standard therapy is available
Adequate bone marrow, liver and kidney function

Exclusion Criteria:

Brain metastases that are symptomatic and/or require treatment with steroids and/or anticonvulsants, or brain metastases that have been treated within 3 months prior to study start
Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the previous 6 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424632

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, Tennessee
Pfizer Investigational Site	Recruiting
Nashville, Tennessee, United States, 37203
Belgium
Pfizer Investigational Site	Recruiting
Leuven, Belgium, 3000

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:	A9491001
Study First Received:	January 18, 2007
Last Updated:	January 4, 2009
ClinicalTrials.gov Identifier:	NCT00424632
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on January 16, 2009