Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To test the safety of PD-0332991 when taken by people who have cancer
Outcome Time Frame:
2.5 years
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A5481001
NCT ID:
NCT00141297
Start Date:
September 2004
Completion Date:
June 2013
Related Keywords:
- Neoplasms
- Lymphoma, Non-Hodgkin
- Advanced cancer
- Neoplasms
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
Pfizer Investigational Site |
Detroit, Michigan 48201 |
Pfizer Investigational Site |
Bronx, New York 10461 |
Pfizer Investigational Site |
Kingston, Pennsylvania 18704-5535 |