A Study Of Oral PF-02341066, A c-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00585195

Purpose

PF-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-02341066 is a new class of drugs called c-Met/hepatocyte growth factor receptor tyrosine kinase inhibitors. This compound is also an inhibitor of the anaplastic lymphoma kinase (called ALK) tyrosine kinase. This research study is the first time PF-02341066 will be given to people. PF-02341066 is taken by mouth daily.

Condition	Intervention	Phase
Systemic Anaplastic Large-Cell Lymphoma Neoplasms Anaplastic Lymphoma Kinase, Human	Drug: PF-02341066	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of PF-02341066, A c-Met/HGFR Selective Tyrosine Kinase Inhibitor, Administered Orally To Patients With Advanced Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Tyrosine

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To test the safety of PF-02341066 when taken by people who have cancer [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
To assess how the body handles blood concentrations of PF-02341066 [ Time Frame: 2.0 years ] [ Designated as safety issue: No ]
To find the dose of PF-02341066 that should be used in future clinical trials [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Anti-tumor activity [ Time Frame: 4.0 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	175
Study Start Date:	May 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: PF-02341066 Escalating doses of PF-02341066 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 50 mg to 2000 mg/day administered either once or twice a day. A treatment cycle is considered to be 28 days.

Eligibility

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

Criteria

Inclusion Criteria:

Advanced malignancies (except leukemias), histologically proven at diagnosis which is refractory to standard of care therapy, or for whom no standard of care therapy is available
Solid tumors must have measurable disease
Adequate blood cell counts, kidney function, liver function and Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 (for the Recommended Phase 2 Cohort, a ECOG score of 2 may be allowed on a case-by-case basis)

Exclusion Criteria:

Major surgery, radiation therapy or anti-cancer therapy within 2 to 4 weeks of starting study treatment, depending on the dose level
Prior stem cell transplant except of patients with lymphoma or myeloma
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: NCT00585195

Contacts

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

Locations

United States, California
Pfizer Investigational Site	Recruiting
Orange, California, United States, 92868
United States, Colorado
Pfizer Investigational Site	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
United States, New York
Pfizer Investigational Site	Recruiting
New York, New York, United States, 10021
Pfizer Investigational Site	Recruiting
New York, New York, United States, 10022
Australia, Victoria
Pfizer Investigational Site	Recruiting
East Melbourne, Victoria, Australia, 3002
Korea, Republic of
Pfizer Investigational Site	Recruiting
Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A8081001
Study First Received:	December 29, 2007
Last Updated:	January 14, 2010
ClinicalTrials.gov Identifier:	NCT00585195 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Tumors positive for c-Met mutations or amplifications; or for ALK fusion gene or ALK amplifications Tumors with chromosomal translocations at the ROS gene

Additional relevant MeSH terms:

Lymphoma, B-Cell
Lymphatic Diseases
Lymphoma, Large B-Cell, Diffuse
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on February 08, 2010