Phase 1 Every-3-Week Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04630)

A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Cyclin-Dependent Kinase (CDK) Inhibitor SCH 727965 Administered Every 3 Weeks in Subjects With Advanced Malignancies

Part 1 and Part 2 of this trial will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered every 3 weeks as a 2 hour intravenous (IV) infusion (Part 1), and as an 8-hour or 24-hour IV infusion (Part 2). Each 3-week period is considered one treatment cycle. Part 3 of this trial will evaluate the effect of coadministration of antiemetic drug aprepitant on the pharmacokinetics of SCH 727965 administered as a 2 hour IV infusion once every 3 weeks.

Inclusion Criteria:

• Age >=18 years, either sex, any race.
• Subjects must have histologically proven solid tumors, non-Hodgkin's lymphoma, or multiple myeloma.
• There must be no known standard therapy, or disease must be refractory to standard therapy.
• Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
• Adequate hematologic, renal, and hepatic organ function and laboratory parameters.

Exclusion Criteria:

• Symptomatic brain metastases or primary central nervous system malignancy.
• Previous radiation therapy to >25% of the total bone marrow.
• Previous treatment with SCH 727965.
• Known HIV infection.