Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma
- Registration Number
- NCT00681798
- Lead Sponsor
- Sanofi
- Brief Summary
The purpose of this study is to define th Maximum Tolerated Dose (MTD) and the recommended dose (RD) of ZD6474 in combination with a fixed standard dose of gemcitabine and capecitabine
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- Confirmed diagnosis of locally advanced unresectable or metastatic pancreatic adenocarcinoma
- ECOG performance status <1
- Measurable disease
Exclusion Criteria
- Severe or uncontrolled systemic disease
- Clinically significant cardiac event such as myocardial infarction
- Any concomitant medication that may cause OTc prolongation, include Torsades de Pointes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose level 1 Vandetanib Vandetanib 100mg/day plus Gemcitabine Dose level 2 Vandetanib Vandetanib 300mg/day plus Gemcitabine Dose level 3 Vandetanib Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose Dose level 4 Vandetanib Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose
- Primary Outcome Measures
Name Time Method Define Maximum Tolerated Dose (MTD) during whole study Define Recommended Dose (RD) during whole study
- Secondary Outcome Measures
Name Time Method Evaluate safety profile during whole study Determine antitumour activity as determined by overall response rate (RR), progression free survival (PFS), disease control rate and duration of response every 2 months
Trial Locations
- Locations (1)
Research Site
🇨🇭Bellinzona, Switzerland