NCT00920595

Study of CEP-9722 as Single-Agent Therapy and as Combination Therapy With Temozolomide in Patients With Advanced Solid Tumors

An Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-9722 (a PARP-1 and PARP-2 Inhibitor) as Single-Agent Therapy and as Combination Therapy With Temozolomide in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Cephalon · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open-label study to evaluate the safety, pharmacokinetics, and pharmacodynamics of CEP-9722 as single-agent therapy and as combination therapy with temozolomide in patients with advanced solid tumors.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	CEP-9722	Starting dose of CEP-9722 is 150 mg/day (total dose). The study consists of a 14-day cycle of CEP-9722 alone, and at least one 28-day cycle of CEP-9722 plus temozolomide (150 mg/m2/day on Days 1-5). Patients who are receiving clinical benefit may receive subsequent cycles of study drug treatment.

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2009-06-15
• Last updated: 2012-08-16

Locations

2 sites across 2 countries: France, United Kingdom