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Sponsored by: |
Pfizer |
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00424632 |
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 |
ChemIDplus related topics: | Gelatin |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | December 2008 |
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer Oncology Clinical Trial Information Service | 1-877-369-9753 | PfizerCancerTrials@emergingmed.com |
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
United States, Tennessee | |||||
Pfizer Investigational Site | Recruiting | ||||
Nashville, Tennessee, United States, 37203 | |||||
Belgium | |||||
Pfizer Investigational Site | Recruiting | ||||
Leuven, Belgium, 3000 |
Pfizer |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
To obtain contact information for a study center near you, click here. 
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Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A9491001 |
First Received: | January 18, 2007 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00424632 |
Health Authority: | United States: Food and Drug Administration |