A Study Of Oral PD-0332991, A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00141297

Purpose

PD-0332991 may work in cancer by stopping cancer cells from multiplying. PD-0332991 is in a new class of drugs called cyclin-dependent kinase (CDK inhibitors). This research study is the first time that PD-0332991 will be given to people. PD-0332991 is taken by mouth daily.

Condition	Intervention	Phase
Neoplasms Lymphoma, Non-Hodgkin	Drug: PD-0332991	Phase I

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: PD 0332991

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A Phase I Clinical, Pharmacokinetic, And Pharmacodynamic Evaluation Of 2 Schedules Of Oral PD 0332991, A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer.

Further study details as provided by Pfizer:

Primary Outcome Measures:

To test the safety of PD-0332991 when taken by people who have cancer [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
To assess how the human body handles blood concentrations of PD-0332991 [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
To find the PD-0332991 dose that should be used in future clinical trials that will study effectiveness [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	September 2004
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PD-0332991: Experimental	Drug: PD-0332991 Dose ranging study - evaluating two oral schedule: (1) 3/1 Schedule - PD-0332991 administered days 1-21 of a 28-day schedule, doses ranging from 25 to 150 mg once daily; (2) 2/1 Schedule - PD-0332991 administered days 1-14 of a 21-days schedule, doses ranging from 100 to 225 mg once daily

Eligibility

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

Criteria

Inclusion Criteria:

Advanced solid tumors (excluding SCLC and retinoblastoma) or follicular of diffuse large cell non-Hodgkin's lymphoma, histologically or cytologically proven at diagnosis which is refractory to or intolerant of established therapy know to provide clinical benefit for their condition; tumors must express Rb
Adequate blood cell counts, kidney function and liver function and and ECOG score of 0, 1, or 2.
Patients may have to have tumor biopsy before and after treatment.

Exclusion Criteria:

Prior stem cell or bone marrow transplant
Uncontrolled infection, unstable or sever intercurrent medical condition, or current drug or alcohol abuse
Active or unstable cardiac disease or history of heart attack within 6 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141297

Locations

United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
Pfizer Investigational Site
New York, New York, United States, 10022
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104

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:	A5481001
Study First Received:	August 30, 2005
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00141297
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Advanced cancer

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Cyclin-Dependent Kinase Inhibitor Proteins

Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases

Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009