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
18 Years
N/A
Both
Neoplasms, Lymphoma, Non-Hodgkin
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 Site | North Adams, Massachusetts 01247 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
