NCT00502164

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
Last Updated

January 21, 2011

Status Verified

January 1, 2009

First QC Date

July 13, 2007

Last Update Submit

January 20, 2011

Conditions

Advanced Prostate Adenocarcinoma

Keywords

Advanced Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma

Secondary Outcomes (1)

  • Explore the PK profile of AZD2171 at steady-state administration to subjects

Interventions

AZD2171DRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

San Francisco, California, United States

Location

Research Site

Chicago, Illinois, United States

Location

Research Site

Nashville, Tennessee, United States

Location

MeSH Terms

Interventions

cediranib

Study Officials

  • Nick Botwood, BSc, MBBS, MRCP, MFPM

    AstraZeneca

    STUDY DIRECTOR

  • Eric Small, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 13, 2007

First Posted

July 17, 2007

Study Start

March 1, 2004

Last Updated

January 21, 2011

Record last verified: 2009-01

Locations

US(3)