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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00502164
First Posted: July 17, 2007
Last Update Posted: January 21, 2011
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.
Information provided by:
AstraZeneca
  Purpose
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
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.

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
  Eligibility

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
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00502164


Locations
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
AstraZeneca
Investigators
Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM AstraZeneca
Principal Investigator: Eric Small, MD University of California, San Francisco
  More Information

ClinicalTrials.gov Identifier: NCT00502164     History of Changes
Other Study ID Numbers: D8480C00003
First Submitted: July 13, 2007
First Posted: July 17, 2007
Last Update Posted: January 21, 2011
Last Verified: January 2009

Keywords provided by AstraZeneca:
Advanced Prostate Cancer

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