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

NCT00920595 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2012-08-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Cephalon

    lead INDUSTRY

Principal Investigators

  • Sponsor's Medical Expert, MD · Cephalon France

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • France
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00920595 on ClinicalTrials.gov