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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00502164
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : January 21, 2011
Information provided by:

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

Condition or disease Intervention/treatment Phase
Advanced Prostate Adenocarcinoma Drug: AZD2171 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00502164     History of Changes
Other Study ID Numbers: D8480C00003
First Posted: July 17, 2007    Key Record Dates
Last Update Posted: January 21, 2011
Last Verified: January 2009

Keywords provided by AstraZeneca:
Advanced Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action