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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.


Phase 1
18 Years
N/A
Not Enrolling
Male
Advanced Prostate Adenocarcinoma

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Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

Nick Botwood, BSc, MBBS, MRCP, MFPM

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D8480C00003

NCT ID:

NCT00502164

Start Date:

March 2004

Completion Date:

Related Keywords:

  • Advanced Prostate Adenocarcinoma
  • Advanced Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location

Research SiteAnaheim, California  
Research SiteArlington Heights, Illinois  
Research SiteChattanooga, Tennessee