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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.


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasms, Lymphoma, Non-Hodgkin

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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 SiteDetroit, Michigan  48201
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535