AZD2171IL/0003: Study to Assess Safety and Tolerability of AZD2171 After Multiple Doses in Patients With Advanced Prostate Cancer
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00502164
Collaborator
(none)
40
3
13.3
Study Details
Study Description
Brief Summary
A study to assess safety and tolerability of AZD2171 after multiple doses in patients with advanced prostate cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
40 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date
:
Mar 1, 2004
Outcome Measures
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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | San Francisco | California | United States | |
| 2 | Research Site | Chicago | Illinois | United States | |
| 3 | Research Site | Nashville | Tennessee | United States |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM, AstraZeneca
- Principal Investigator: Eric Small, MD, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00502164
Other Study ID Numbers:
- D8480C00003
First Posted:
Jul 17, 2007
Last Update Posted:
Jan 21, 2011
Last Verified:
Jan 1, 2009
Keywords provided by ,
,
Additional relevant MeSH terms: