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

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

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Key information

Conditions

Advanced Prostate Adenocarcinoma

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, San Francisco, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD2171

Drug

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Acronym: AZD2171IL/0003

Important dates

Study start: 2004
First posted: Jul 17, 2007
Registry last updated: Jan 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed