NCT00871663

Phase 1 Weekly Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04629AM6)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Solid Tumors
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Leukemia, Lymphocytic, Chronic. B-Cell

Interventions

Type	Name	Description
DRUG	SCH 727965	Dose escalation of SCH 727965 IV administered in 28-day cycles, on Days 1, 8, and 15 of each 28-day cycle.

Timeline

• Start date: 2006-08-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2009-03-30
• Last updated: 2015-04-20