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Phase 2
18 Years
N/A
Not Enrolling
Male
Prostatic Neoplasms, Metastases, Neoplasm

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Trial Information


Inclusion Criteria:



- Men 18 years & older

- Confirmed diagnosis of prostate cancer with bone metastases

Exclusion Criteria:

- No more than 2 prior chemotherapy regimens

- No radiation, chemotherapy or bisphosphonates in the past 4 weeks

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Dose Limiting Toxicities (DLTs)

Outcome Description:

DLT is defined as experiencing Common Toxicity Criteria (CTC) grade 3 or 4 headache with onset within 24 h of receiving ZD4054, CTC grade 2 rhinitis leading to the withdrawal of the subject, or other CTC grade 3 or 4 toxicity that was considered to be related to ZD4054 treatment. The numbers of patients with a DLT are reported.

Outcome Time Frame:

Baseline to Day 29.

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

4054IL/0004

NCT ID:

NCT00055471

Start Date:

June 2003

Completion Date:

October 2005

Related Keywords:

  • Prostatic Neoplasms
  • Metastases, Neoplasm
  • prostate cancer
  • Metastatic prostate cancer
  • bone metastases
  • Neoplasms
  • Neoplasm Metastasis
  • Prostatic Neoplasms

Name

Location
Research Site Akron, Ohio  
Research Site Appleton, Wisconsin