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

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501605
• Other study ID #: D8480C00001
• Status: Completed
• Phase: Phase 1
• First received: July 13, 2007
• Last updated: January 20, 2011
• Start date: February 2003
• Est. completion date: February 2006

Study information

• Verified date: January 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2006
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• AZD2171

Locations

Country	Name	City	State
Germany	Research Site	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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