Phase I Study With AZD2171 in Patients With Advanced Solid Malignant Tumors and Liver Metastases
Single centre recruiting approximately 80 patients who are given a rising single, followed by multiple, ascending oral dose of AZD2171, assessing the safety and tolerability of AZD2171 in patients with solid tumors and metastatic liver disease.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Single Centre 2-part Open Study to Assess the Safety and Tolerability of AZD2171 Following Single and Multiple Oral Doses in Patients With Advanced Solid Malignant Tumors and Liver Metastases|
- primary objective is to evaluate the safety and tolerability of ascending single&multiple oral doses of AZD2171 by assessment of AEs,BP,HR,RR,ECG,clinical chemistry,haematology,urinalysis incl 24hr collection for protein&creatinine and physical exam.
- PK,assess the effects of AZD2171 on surrogate markets of activity and to make a preliminary assessment of anti-tumor activity by measurement of tumor response and time to progression
|Study Start Date:||February 2003|
|Study Completion Date:||February 2006|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
|Study Director:||Nick Botwood, BSc, MBBS, MRCP, MFPM||AstraZeneca|
|Principal Investigator:||J. Drevs, PD||Klinik fur.Internistische Onkologie|