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A Phase II, Randomised, Open-Label, Pilot Study to Evaluate the Safety and Effects on Bone Resorption of AZD0530 in Patients With Prostate Cancer or Breast Cancer With Metastatic Bone Disease.


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Prostate Cancer, Bone Neoplasms

Thank you

Trial Information

A Phase II, Randomised, Open-Label, Pilot Study to Evaluate the Safety and Effects on Bone Resorption of AZD0530 in Patients With Prostate Cancer or Breast Cancer With Metastatic Bone Disease.


Inclusion Criteria:



- Subjects 18 years or older with Prostate Cancer or Breast Cancer with Metastatic Bone
Disease Have evidence of recurrence or disease progression

- At least one radiographically confirmed metastatic bone lesion

- No change of cancer therapy for at least 8 weeks before randomization

Exclusion Criteria:

- Have had any prior exposure to bisphosphonate

- Have had hip fractures or bilateral hip prothesis fracture of any kind or surgery to
bone within the past 12 months

- Inadequate renal function or low haemoglobin

- Inadequate liver function as demonstrated by serum bilirubin ≥2 times the upper
limits of reference range (ULRR) or by alanine aminotransferase (ALT), aspartate
aminotransferase(AST) or ALP ≥2.5 times the ULRR (≥5 times the ULRR in the presence
of liver metastases). If bone metastases are present and liver function is otherwise
considered adequate by the investigator then elevated ALP will not exclude the
patient.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4

Outcome Description:

Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.

Outcome Time Frame:

Baseline to Week 4

Safety Issue:

No

Principal Investigator

Richard Finkelman, DDS, PhD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D8180C00034

NCT ID:

NCT00558272

Start Date:

February 2008

Completion Date:

August 2012

Related Keywords:

  • Breast Cancer
  • Prostate Cancer
  • Bone Neoplasms
  • breast cancer
  • prostate cancer
  • metastatic bone disease
  • Subjects with breast cancer or prostate cancer with metastatic bone disease
  • Bone Diseases
  • Bone Neoplasms
  • Breast Neoplasms
  • Neoplasms
  • Prostatic Neoplasms

Name

Location
Research Site Anaheim, California  
Research Site Danbury, Connecticut  
Research Site Boca Raton, Florida  
Research Site Baltimore, Maryland  
Research Site Battle Kreek, Michigan  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Allentown, Pennsylvania