A phase I study of the combination of daily oral pazopanib with intravenous ifosfamide in patients with advanced solid malignancies.
Recruiting
- Conditions
- advanced solid malignancysarcomaphase Ipazopanibifosfamidegevorderde solide tumorsarcoomfase Iifosfamide
- Registration Number
- NL-OMON28441
- Lead Sponsor
- Erasmus University Medical center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1. Subjects must provide written informed consent prior to performance of study
specific procedures or assessments, and must be willing to comply with treatment
and follow up assessments and procedures;
Exclusion Criteria
1. Unable to discontinue prohibited medications, as listed in Section 5.5.2, 14 days or
five half-lives (whichever is longer) of the drug prior to Visit 1 and for the duration
of the study;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the MTD of pazopanib in combination with standard doses of<br>ifosfamide, dosed according to two regimens (continuous ifosfamide infusion [Arm A]; short ifosfamide infusion [Arm B]), in subjects with solid malignancies.
- Secondary Outcome Measures
Name Time Method 1. To assess the safety and tolerability of the investigational combination of pazopanib and ifosfamide;<br /><br>2. To characterize the PK of pazopanib when administered alone and with ifosfamide,<br>and of ifosfamide and its metabolites when administered alone and with pazopanib<br>(with continuous and short ifosfamide regimens);<br /><br>3. To analyze biomarkers in blood associated with clinical outcome to treatment to<br>allow identification of markers useful for selecting subjects likely to benefit from<br>therapy;<br /><br>4. To explore the anti-tumor activity of the combination of pazopanib and ifosfamide<br>(continuous and short ifosfamide regimens) in solid tumors.