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A Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of AG-024322, An Inhibitor Of Cyclin-Dependent Kinase 1, 2 And 4, Administered Intravenously Daily For 5 Days Every 3 Weeks To Patients With Advanced Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms, Lymphoma, Non-Hodgkin

Thank you

Trial Information

A Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of AG-024322, An Inhibitor Of Cyclin-Dependent Kinase 1, 2 And 4, Administered Intravenously Daily For 5 Days Every 3 Weeks To Patients With Advanced Cancer


The study was prematurely discontinued due to the inability of the compound to adequately
differentiate from other treatment options in the clinical endpoint and necessary product
profile on April 13, 2007. Safety profile was not the reason that led to the discontinuation
of the program.


Inclusion Criteria:



- Advanced solid tumors 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

- Adequate blood cell counts, kidney function and liver function and and ECOG score of
0 or 1.

Exclusion Criteria:

- Prior high-dose chemotherapy requiring hemapoietic stem cell rescue

- Previous radiation therapy to >25% of the bone marrow

- 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 AG-024322 when taken by people who have cancer

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A7091001

NCT ID:

NCT00147485

Start Date:

December 2004

Completion Date:

August 2007

Related Keywords:

  • Neoplasms
  • Lymphoma, Non-Hodgkin
  • Neoplasms
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535