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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: July 13, 2007
Last updated: January 20, 2011
Last verified: January 2009
A study to assess safety and tolerability of AZD2171 after multiple doses in patients with advanced prostate cancer.

Condition Intervention Phase
Advanced Prostate Adenocarcinoma
Drug: AZD2171
Phase 1

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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma

Secondary Outcome Measures:
  • Explore the PK profile of AZD2171 at steady-state administration to subjects

Estimated Enrollment: 40
Study Start Date: March 2004

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00502164

United States, California
Research Site
San Francisco, California, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
Sponsors and Collaborators
Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM AstraZeneca
Principal Investigator: Eric Small, MD University of California, San Francisco
  More Information Identifier: NCT00502164     History of Changes
Other Study ID Numbers: D8480C00003 
Study First Received: July 13, 2007
Last Updated: January 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Advanced Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses processed this record on May 03, 2016