NCT00871910

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Solid Tumors
• Lymphoma, Non-Hodgkin
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	SCH 727965	SCH 727965 2 hour IV infusion on Day 1 of each 3 week cycle, administered in dose-escalating cohorts (Part 1 of the trial)
DRUG	SCH 727965	SCH 727965 8 hour IV infusion on Day 1 of each 3 week cycle,in dose-escalating cohorts
DRUG	SCH 727965	SCH 727965 24 hour IV infusion on Day 1 of each 3 week cycle, in dose-escalating cohorts
DRUG	SCH 727965	SCH 727965 29.6 mg/m2 2 hour IV infusion on Day 1 of each 3 week cycle
DRUG	Aprepitant	Oral aprepitant in Cycle 1 or Cycle 2, depending on the study arm: 125 mg 1 hour prior to the SCH 727965 infusion on Day 1, and 80 mg on Days 2 and 3.
DRUG	Ondansetron	Ondansetron 32 mg IV 30 minutes prior to the SCH 727965 infusion on Day 1 of Cycles 1 and 2.
DRUG	Dexamethasone	Oral dexamethasone in Cycles 1 and 2: 12 mg 30 minutes prior to the SCH 727965 infusion on Day 1, and 8 mg in the morning on Days 2, 3, and 4.

Timeline

• Start date: 2006-10-11
• Primary completion: 2010-02-22
• Completion: 2010-02-22
• First posted: 2009-03-30
• Last updated: 2017-10-23