Study to Assess Safety and Tolerability of AZD2171 After Multiple Doses in Patients With Advanced Prostate Cancer (AZD2171IL/0003)
January 20, 2011 updated by: AstraZeneca
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.
A study to assess safety and tolerability of AZD2171 after multiple doses in patients with advanced prostate cancer.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States
- Research Site
-
-
Illinois
-
Chicago, Illinois, United States
- Research Site
-
-
Tennessee
-
Nashville, Tennessee, United States
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Explore the PK profile of AZD2171 at steady-state administration to subjects
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM, AstraZeneca
- Principal Investigator: Eric Small, MD, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Study Registration Dates
First Submitted
July 13, 2007
First Submitted That Met QC Criteria
July 13, 2007
First Posted (Estimate)
July 17, 2007
Study Record Updates
Last Update Posted (Estimate)
January 21, 2011
Last Update Submitted That Met QC Criteria
January 20, 2011
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D8480C00003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.