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.
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Advanced Prostate Adenocarcinoma
Male
Advanced Prostate Adenocarcinoma
Trial Information
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma
Principal Investigator
Nick Botwood, BSc, MBBS, MRCP, MFPM
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
D8480C00003
NCT ID:
NCT00502164
Start Date:
March 2004
Completion Date:
Related Keywords:
- Advanced Prostate Adenocarcinoma
- Advanced Prostate Cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Prostatic Neoplasms
Name | Location |
|---|---|
| Research Site | Anaheim, California |
| Research Site | Arlington Heights, Illinois |
| Research Site | Chattanooga, Tennessee |
