Lymphoma, Non-Hodgkin, Neoplasms
Conditions
Brief summary
AG-024322 may work in cancer by stopping cancer cells from multiplying. AG-024322 is and intravenous drug from a new class of drugs call cyclin-dependent kinase (CDK inhibitors). This research study is the first time that AG-024322 will be given to people.
Detailed description
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.
Interventions
DRUGAG-024322
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test the safety of AG-024322 when taken by people who have cancer | — |
| To find the AG-024322 dose that should be used in future clinical trials that will study effectiveness | — |
| To assess how the human body handles blood concentrations of AG-024322 | — |
Countries
United States
Outcome results
None listed