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Study to Assess Safety and Tolerability of AZD2171 After Multiple Doses in Patients With Advanced Prostate Cancer

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.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00502164
Acronym
AZD2171IL/0003
Enrollment
40
Registered
2007-07-17
Start date
2004-03-31
Completion date
Unknown
Last updated
2011-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Prostate Adenocarcinoma

Keywords

Advanced Prostate Cancer

Brief summary

A study to assess safety and tolerability of AZD2171 after multiple doses in patients with advanced prostate cancer.

Interventions

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma

Secondary

MeasureTime frame
Explore the PK profile of AZD2171 at steady-state administration to subjects

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026