A Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00783328

Purpose

To evaluate safety and tolerability of PF-00299804 in Japanese patients with advanced malignant solid tumors at doses up to the clinically recommended phase 2 dose in non-Japanese studies.

Condition	Intervention	Phase
Neoplasms	Drug: PF-00299804	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A Clinical Phase 1 Safety And Pharmacokinetic/Pharmacodynamic Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors

Further study details as provided by Pfizer:

Primary Outcome Measures:

Overall safety: type, grade and frequency of all adverse events and laboratory abnormalities [ Time Frame: End of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To explore PD markers [ Time Frame: End of study ] [ Designated as safety issue: No ]
To evaluate the plasma pharmacokinetics of PF-00299804 in Japanese patients following single and multiple dosing [ Time Frame: End of study ] [ Designated as safety issue: No ]
To assess any clinical evidence of anti-tumor activity of PF-00299804 per RECIST [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	November 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Open label single arm trial	Drug: PF-00299804 Dosage form: 5 mg and 20 mg tablet Dosage: 15 mg, 30 mg and 45 mg, orally, once daily Number of Cycles: until progression or unacceptable toxicity develops.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Malignant solid tumor with no currently approved treatment
Adequate functions Bone Marrow, Renal, Liver and Cardiac

Exclusion Criteria:

Any surgery, radiotherapy within 4 weeks of baseline disease assessments
Clinically significant abnormalities of the cornea
Patients with symptomatic brain/central nerve system metastases
Any clinically significant gastrointestinal abnormalities
Uncontrolled or significant cardiovascular disease
Patients with significant interstitial pneumonia or pulmonary fibrosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783328

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

Japan, Shizuoka
Pfizer Investigational Site	Recruiting
Sunto-gun, Shizuoka, Japan

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:	A7471005
Study First Received:	October 28, 2008
Last Updated:	December 20, 2008
ClinicalTrials.gov Identifier:	NCT00783328
Health Authority:	Japan: Institutional Review Board

Keywords provided by Pfizer:

solid tumor

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009