Study to Assess Safety and Tolerability of AZD2171 After Multiple Doses in Patients With Advanced Prostate Cancer

Phase 1

Completed

• Conditions: Advanced Prostate Adenocarcinoma

• Registration Number: NCT00502164
• Lead Sponsor: AstraZeneca

Brief Summary

A study to assess safety and tolerability of AZD2171 after multiple doses in patients with advanced prostate cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2007-07-13
• Study First Submitted QC: 2007-07-13
• Study First Posted: 2007-07-17
• Status Verified: 2009-01
• Last Update Submitted: 2011-01-20
• Last Update Posted: 2011-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Men, 18yrs and older
• Histological or cytological confirmation of prostate adenocarcinoma (symptomatic or asymptomatic)
• Prior hormonal therapy, and/or no more than 1 prior chemotherapy regimen (including estramustine and/or corticosteroids) for treatment of prostate adenocarcinoma

Exclusion Criteria

• Prior radiotherapy to bone metastases within 4 weeks prior to screening
• any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy
• Brain metastases or spinal cord compression, unless treated at least 4 weeks before entry, and stable with steroid treatment for 1 week.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma

Secondary Outcome Measures

Name	Time	Method
Explore the PK profile of AZD2171 at steady-state administration to subjects

Trial Locations

Locations (1)

Research Site; 🇺🇸 Nashville, Tennessee, United States