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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00558272
Other study ID # D8180C00034
Secondary ID
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


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
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