A Multicenter Phase 2 Study of Oral N-Acetyl Dinaline (CI-994) in the Treatment of Patients With Advanced Myeloma
OBJECTIVES: I. Determine the antitumor activity of CI-994 in patients with advanced myeloma.
II. Determine the response rate, response duration, and overall survival of this patient
population with this treatment regimen. III. Determine the safety of this treatment in these
OUTLINE: This is a multicenter study. Patients receive CI-994 orally daily. Treatment
continues in the absence of disease progression or unacceptable toxicity. Patients are
followed for 30 days and then every 2 months.
PROJECTED ACCRUAL: A total of 8-63 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (ORR)
Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Melissa Alsina, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|