Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Prostatic Neoplasms

Breast Neoplasms

Bone Resorption

Bone Diseases

Bone Neoplasms

Breast Diseases

Skin Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Bone Density Conservation Agents

All Drugs and Chemicals

Antineoplastic Agents

Zoledronic Acid

Saracatinib

Enzyme Inhibitors

Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period

AZD0530

Richard Finkelman, DDS, PhD

Meabe Aklilu, MD

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

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.

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.

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.

AstraZeneca

safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69

AZD0530 175 mg

Zoledronic Acid 4 mg

Total

Age Continuous

Sex: Female, Male

Non-compliant patients were excluded from the biomarker analysis, in order to accurately assess effects due to treatment. The compliance criteria did not apply to the zoledronic acid arm, which led to an imbalance in the number of subjects analysed.

Gerard Lynch

The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.

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

Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase (bALP) at Week 4

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

Percentage Change From Baseline in Serum N-terminal Propeptide of Type I Procollagen (PINP) at Week 4

Percentage Change From Baseline in Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) at 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

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

Saracatinib: Area Under the Curve at Steady State (AUCss)

Saracatinib: Plasma Clearance at Steady State (CLss/F)

Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)

Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)

Saracatinib: Time to Cssmax (Tmax)

N-desmethyl Metabolite of Saracatinib: Area Under the Curve at Steady State (AUCss)

N-desmethyl Metabolite of Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)

N-desmethyl Metabolite of Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)

N-desmethyl Metabolite of Saracatinib: AUCss Metabolite to Parent Ratio

N-desmethyl Metabolite of Saracatinib: Time to Cssmax (Tmax)

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease	NCT00558272	Breast Cancer Prostate Cancer Bone Neoplasms	AZD0530 Zoledronic Acid	18 Years -	AstraZeneca
Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease	NCT00558272	Breast Cancer Prostate Cancer Bone Neoplasms	AZD0530 Zoledronic Acid	18 Years -	AstraZeneca
Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease	NCT00558272	Breast Cancer Prostate Cancer Bone Neoplasms	AZD0530 Zoledronic Acid	18 Years -	AstraZeneca
Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease	NCT00558272	Breast Cancer Prostate Cancer Bone Neoplasms	AZD0530 Zoledronic Acid	18 Years -	AstraZeneca

Spots Global Cancer Trial Database for subjects with breast cancer or prostate cancer with metastatic bone disease