A phase I study of the combination of daily oral pazopanib with intravenous docetaxel in patients with advanced solid malignancies.
Recruiting
- Conditions
- advanced solid malignanciescancer
- Registration Number
- NL-OMON24614
- Lead Sponsor
- Erasmus University Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 72
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;
2. Histologically or cytologically confirmed diagnosis of advanced solid tumor for which docetaxel-based systemic therapy is considered appropriate or for which there is no standard therapy;
Exclusion Criteria
1. Unable to discontinue prohibited medications, 14 days or five half-lives (whichever is longer) of the drug prior to Visit 1 and for the duration of the study;
2. Clinically significant gastrointestinal abnormalities which might interfere with oral dosing;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the MTD of pazopanib in combination with docetaxel, dosed according to two regimens (3-weekly [Arm A]; weekly [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 docetaxel;<br /><br>2. To characterize the PK of pazopanib when administered alone and with docetaxel, and of docetaxel when administered alone and with pazopanib;<br /><br>3. To explore the anti-tumor activity of the combination of pazopanib and docetaxel in solid tumors.