Phase I Study With AZD2171 in Patients With Advanced Solid Malignant Tumors and Liver Metastases

Phase 1

Completed

• Conditions: Advanced Solid Tumor; Liver Metastases

• Registration Number: NCT00501605
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2005-04
• Study Completion: 2006-02
• Study First Submitted: 2007-07-13
• Study First Submitted QC: 2007-07-13
• Study First Posted: 2007-07-16
• Status Verified: 2009-01
• Last Update Submitted: 2011-01-20
• Last Update Posted: 2011-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Provision of written informed consent
• Male/female, 18 yr or over
• WHO status 0-2
• Refractory advanced solid tumor

Exclusion Criteria

• Radiotherapy within 4 weeks of starting AZD2171 treatment
• Low haemoglobin level
• Low platelet or neutrophil counts

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇩🇪 Freiburg, Germany