A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Cyclin-Dependent Kinase (CDK) Inhibitor SCH 727965 Administered Weekly in Subjects With Advanced Malignancies
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Cyclin-Dependent Kinase (CDK) Inhibitor SCH 727965 Administered Weekly in Subjects With Advanced Malignancies
The study will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered as an intravenous infusion on Days 1, 8 and 15 of each 28 day cycle in participants with solid tumors, non Hodgkins lymphoma, multiple myeloma or chronic lymphocytic leukemia.
Inclusion Criteria:
Age >=18 years, either sex, any race.
Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
There must be no known standard therapy, or disease must be refractory to standard therapy
Adequate hematologic, renal, and hepatic organ function and laboratory parameters
For advanced solid tumors, non-Hodgkin's lymphoma, or multiple myeloma:
Subjects with multiple myeloma must have measurable disease defined as:
Serum monoclonal protein greater than 0.5 g/dL or urine light chain excretion of greater than 0.2 g/24-hour obtained within 4 weeks prior to the start of treatment.
Participants with lower M protein values or nonsecretory myeloma are eligible if measurable disease can be established within 4 weeks prior to start of treatment, such as:
For B-cell chronic lymphocytic leukemia (B-CLL):
Exclusion Criteria: