Back to resultsStudy to Assess Safety and Tolerability of AZD2171 After Multiple Doses in Patients With Advanced Prostate Cancer (AZD2171IL/0003)
Primary Purpose
Advanced Prostate Adenocarcinoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AZD2171
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Prostate Adenocarcinoma focused on measuring Advanced Prostate Cancer
Eligibility Criteria
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.
Sites / Locations
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma
Secondary Outcome Measures
Explore the PK profile of AZD2171 at steady-state administration to subjects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00502164
Brief Title
Study to Assess Safety and Tolerability of AZD2171 After Multiple Doses in Patients With Advanced Prostate Cancer
Acronym
AZD2171IL/0003
Official Title
A Phase I Open-label Dose Escalation Study to Assess the Safety and Tolerability of AZD2171 Following Multiple Oral Doses in Subjects With Advanced Prostate Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
A study to assess safety and tolerability of AZD2171 after multiple doses in patients with advanced prostate cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Prostate Adenocarcinoma
Keywords
Advanced Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AZD2171
Primary Outcome Measure Information:
Title
To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma
Secondary Outcome Measure Information:
Title
Explore the PK profile of AZD2171 at steady-state administration to subjects
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Botwood, BSc, MBBS, MRCP, MFPM
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eric Small, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Assess Safety and Tolerability of AZD2171 After Multiple Doses in Patients With Advanced Prostate Cancer
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