NCT00502164CompletedPhase 1
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.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 40
- Locations
- 3
- Primary Endpoint
- To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma
Study Overview
Brief Summary
A study to assess safety and tolerability of AZD2171 after multiple doses in patients with advanced prostate cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma
Secondary Outcomes
- Explore the PK profile of AZD2171 at steady-state administration to subjects
Investigators
Study Sites (3)
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