Study to Assess Safety and Tolerability of AZD2171 After Multiple Doses in Patients With Advanced Prostate Cancer (AZD2171IL/0003)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Advanced Prostate Adenocarcinoma

Treatments: Drug: AZD2171

Study type: Interventional

Funder types: Industry

Identifiers

NCT00502164

D8480C00003

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)