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

AstraZeneca139 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

139

Conditions

Breast Cancer Prostate Cancer Bone Neoplasms

Interventions

AZD0530DRUG

Daily oral dose

Zoledronic AcidDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (28)

Research Site

Pleasant Hill, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to Week 4

Secondary Outcomes

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.

Time frame: Baseline to Week 4

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.

Time frame: Baseline to Week 4

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.

Time frame: Baseline to Week 4

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.

Time frame: Baseline to Week 4

Percentage Change From Baseline in Urine N-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (NTx/Cr) at Week 4

Data from ClinicalTrials.gov

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Research Site

Sacramento, California, United States

Research Site

Middlebury, Connecticut, United States

Research Site

Aventura, Florida, United States

Research Site

Baltimore, Maryland, United States

Research Site

Ann Arbor, Michigan, United States

Research Site

Poughkeepsie, New York, United States

Research Site

Winston-Salem, North Carolina, United States

Research Site

Hershey, Pennsylvania, United States

Research Site

Edmonton, Alberta, Canada

...and 18 more locations

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.

Time frame: Baseline to Week 4

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.

Time frame: Baseline to Week 4

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.