Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00558272
• Other study ID #: D8180C00034
• Status: Completed
• Phase: Phase 2
• First received: November 13, 2007
• Last updated: May 23, 2013
• Start date: February 2008
• Est. completion date: August 2012

Study information

• Verified date: May 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaDenmark: Danish Medicines AgencySpain: Spanish Agency of MedicinesSweden: Medical Products AgencyNorway: Norwegian Medicines AgencyPortugal: National Pharmacy and Medicines InstituteUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: August 2012
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Bone Diseases
• Bone Neoplasms
• Breast Cancer
• Breast Neoplasms
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• AZD0530
Daily oral dose
• Zoledronic Acid

Locations

Country	Name	City	State
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Denmark	Research Site	Arhus N
Denmark	Research Site	Frederica
Denmark	Research Site	Herlev
Denmark	Research Site	Holstebro
Norway	Research Site	Kristiansand
Norway	Research Site	Oslo
Portugal	Research Site	Lisboa
Spain	Research Site	Barcelona	Cataluna
Spain	Research Site	Lerida	Cataluna
Spain	Research Site	Valencia	Comunidad Valenciana
Sweden	Research Site	Uppsala
United Kingdom	Research Site	Cardiff
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Manchester
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Aventura	Florida
United States	Research Site	Baltimore	Maryland
United States	Research Site	Hershey	Pennsylvania
United States	Research Site	Middlebury	Connecticut
United States	Research Site	Pleasant Hill	California
United States	Research Site	Poughkeepsie	New York
United States	Research Site	Sacramento	California
United States	Research Site	Winston-salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Norway,  Portugal,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4	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.	Baseline to Week 4	No
Secondary	Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase (bALP) at Week 4	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.	Baseline to Week 4	No
Secondary	Percentage Change From Baseline in Serum Cross-linked C-terminal Telopeptide of Type I Collagen (ICTP) at Week 4	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.	Baseline to Week 4	No
Secondary	Percentage Change From Baseline in Serum N-terminal Propeptide of Type I Procollagen (PINP) at Week 4	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.	Baseline to Week 4	No
Secondary	Percentage Change From Baseline in Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) at Week 4	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.	Baseline to Week 4	No
Secondary	Percentage Change From Baseline in Urine N-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (NTx/Cr) at Week 4	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.	Baseline to Week 4	No
Secondary	Percentage Change From Baseline in Urine Alpha-alpha C-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (aaCTx/Cr) at Week 4	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.	Baseline to Week 4	No
Secondary	Saracatinib: Area Under the Curve at Steady State (AUCss)	Previous studies have shown that saracatinib reduces osteoclast function and bone resorption. Bone turnover, the combined result of bone formation and bone resorption, can be assessed in real time by measuring specific markers of bone turnover in serum and in urine. These markers were assessed in a study of patients with metastatic bone disease treated with saracatinib. Specific assays are available to quantitate these markers in serum and urine. In this study the effects of saracatinib on bone turnover were compared with the effects of zoledronic acid, a marketed drug known to inhibit bone resorption in cancer patients with bone metastatses.	Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29	No
Secondary	Saracatinib: Plasma Clearance at Steady State (CLss/F)		Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29	No
Secondary	Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)		Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29	No
Secondary	Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)		Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29	No
Secondary	Saracatinib: Time to Cssmax (Tmax)		Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29	No
Secondary	N-desmethyl Metabolite of Saracatinib: Area Under the Curve at Steady State (AUCss)		Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29	No
Secondary	N-desmethyl Metabolite of Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)		Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29	No
Secondary	N-desmethyl Metabolite of Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)		Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29	No
Secondary	N-desmethyl Metabolite of Saracatinib: AUCss Metabolite to Parent Ratio		Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29	No
Secondary	N-desmethyl Metabolite of Saracatinib: Time to Cssmax (Tmax)		Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29	No

External Links

•   Cancer Study Locator (US and Canada only)