A Multicenter Phase 2 Study of CI-1040 In Patients With Advanced Nonsmall-Cell Lung Cancer, Breast Cancer, Colon Cancer Or Pancreatic Cancer
- Determine the antitumor activity of CI-1040 in patients with non-small cell lung,
breast, colon, or pancreatic cancer.
- Determine the safety profile of this drug in these patients.
- Assess quality of life (overall and for each tumor type) of patients treated with this
- Determine the relationship between study drug concentration and antitumor response in
these patients and target suppression and safety of this drug.
- Correlate target suppression (pERK) with antitumor effects of this drug in these
- Correlate the mRNA expression profile of the tumors with antitumor effects of this drug
in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor type
(non-small cell lung vs breast vs colon vs pancreas).
Patients receive oral CI-1040 twice daily on days 1-21. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 28 days during the first 6 months of
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 52-172 patients (13-43 per stratum) will be accrued for this
Primary Purpose: Treatment
John J. Rinehart, MD
University of Alabama at Birmingham
United States: Food and Drug Administration
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|