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

Advanced Prostate Adenocarcinoma Clinical Trial

— AZD2171IL/0003  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502164
• Other study ID #: D8480C00003
• Status: Completed
• Phase: Phase 1
• First received: July 13, 2007
• Last updated: January 20, 2011
• Start date: March 2004

Study information

• Verified date: January 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Advanced Prostate Adenocarcinoma
• Prostatic Neoplasms

Intervention

Drug:
• AZD2171

Locations

Country	Name	City	State
United States	Research Site	Chicago	Illinois
United States	Research Site	Nashville	Tennessee
United States	Research Site	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma
Secondary	Explore the PK profile of AZD2171 at steady-state administration to subjects