Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease. - Full Text View

Purpose

The purpose of this study is to determine the effect of AZD0530 on subjects with breast cancer or prostate cancer with metastatic bone disease in comparison to zoledronic acid.

Condition	Intervention	Phase
Breast Cancer Prostate Cancer Bone Neoplasms	Drug: AZD0530 Drug: Zoledronic Acid Drug: Calcium Drug: Vitamin D	Phase II

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Bone Cancer Bone Diseases Breast Cancer Cancer Prostate Cancer

ChemIDplus related topics:

Zoledronic acid Calcium gluconate Vitamin D Ergocalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Official Title:	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.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To estimate the effect of AZD0530 plus standard of care (SoC) compared with Zoledronic acid plus SoC on bone resorption by assessment of serum BCTx. [ Designated as safety issue: No ]

Secondary Outcome Measures:

To investigate safety and tolerability of AZD0530 in patients with either breast or prostate cancer who have metastatic bone disease by assessment of AEs, PE's, BP, pulse, ECF and lab findings.

Estimated Enrollment:	122
Study Start Date:	February 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Daily oral dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects 18 years or older with Prostate Cancer or Breast Cancer with Metastatic Bone DiseaseHave 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 liver function, renal function or low haemoglobin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558272

Contacts


Contact: AZD0530 Clinical Trials Mailbox		AZD0530ClinicalTrialsMailbox@astrazeneca.com

Show 25 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Richard Finkelman, DDS, PhD	AstraZeneca

Principal Investigator:	Meabe Aklilu, MD	Wake Forest University

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Mary Stuart, MD - Medical Science Director EPT1 )
Study ID Numbers:	D8180C00034
First Received:	November 13, 2007
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00558272
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Denmark: Danish Medicines Agency; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency; Portugal: National Pharmacy and Medicines Institute; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

breast cancer

prostate cancer

metastatic bone disease

Subjects with breast cancer or prostate cancer with metastatic bone disease

Study placed in the following topic categories:

Zoledronic acid

Bone Neoplasms

Bone Resorption

Skin Diseases

Genital Neoplasms, Male

Prostatic Diseases

Bone neoplasms

Ergocalciferols

Breast Neoplasms

Urogenital Neoplasms

Genital Diseases, Male

Bone Diseases

Vitamin D

Musculoskeletal Diseases

Prostatic Neoplasms

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Physiological Effects of Drugs

Bone Density Conservation Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00558272