An Open-label, Phase I Study to determine the Safety and Pharmacokinetics of JNJ-26483327, a Multi-targeted Kinase Inhibitor, administered to Subjects with Advanced Stage and/or Refractory Solid Malignancies
Completed
- Conditions
- cancer10027655
- Registration Number
- NL-OMON29756
- Lead Sponsor
- Johnson & Johnson Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Male or female, Age 18 years or older, Histologically or cytologically confirmed solid malignancy that is advanced stage and/or refractory and progressing and for which standard treatments do not exist or are no longer effective , ECOG Performance Status 0 - 2, Life expectancy > 3 months.
Exclusion Criteria
Known central nervous system metastases, female patient who is pregnant or is breast-feeding, Chemotherapy, radiotherapy, immunotherapy within 4 weeks before dosing with JNJ-26483327, History of uncontrolled heart disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the safety [(adverse event profile, dose-limiting toxicity (DLT)<br /><br>and maximum tolerated dose (MTD)] of JNJ-26483327in male and female subjects<br /><br>with cancer.<br /><br>To determine the pharmacokinetics (PK) of JNJ-26483327 following oral<br /><br>administration in male and female subjects with cancer.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To monitor the anti-tumor activity of JNJ-26483327 subjects with cancer.<br /><br>To explore pharmacodynamic effects of JNJ-26483327 in skin/tumor biopsies and<br /><br>in blood/serum in subjects with cancer. </p><br>