Phase 2
N=139
Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease
Breast Cancer · Prostate Cancer · Bone Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00558272 ↗Enrolled (actual)
139
Serious AEs
11.0%
Results posted
Jun 2011
Primary outcome: Primary: Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4 — -71.1; -68.4 Percentage change in betaCTX
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD0530 (Drug); Zoledronic Acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4 |
-71.1; -68.4 | — |
| SECONDARY Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase (bALP) at Week 4 |
-13.2; -3.1 | — |
| SECONDARY Percentage Change From Baseline in Serum Cross-linked C-terminal Telopeptide of Type I Collagen (ICTP) at Week 4 |
-40.2; 7.4 | — |
| SECONDARY Percentage Change From Baseline in Serum N-terminal Propeptide of Type I Procollagen (PINP) at Week 4 |
-26.1; -29.5 | — |
| SECONDARY Percentage Change From Baseline in Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) at Week 4 |
-36.9; -43.4 | — |
| SECONDARY Percentage Change From Baseline in Urine N-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (NTx/Cr) at Week 4 |
-57.2; -70.1 | — |
| 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 |
-68.2; -82.8 | — |
| SECONDARY Saracatinib: Area Under the Curve at Steady State (AUCss) |
7261 | — |
| SECONDARY Saracatinib: Plasma Clearance at Steady State (CLss/F) |
24.10 | — |
| SECONDARY Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max) |
396.0 | — |
| SECONDARY Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min) |
229.0 | — |
| SECONDARY Saracatinib: Time to Cssmax (Tmax) |
4.0 | — |
| SECONDARY N-desmethyl Metabolite of Saracatinib: Area Under the Curve at Steady State (AUCss) |
1069 | — |
| SECONDARY N-desmethyl Metabolite of Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max) |
62.80 | — |
| SECONDARY N-desmethyl Metabolite of Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min) |
34.30 | — |
| SECONDARY N-desmethyl Metabolite of Saracatinib: AUCss Metabolite to Parent Ratio |
0.1420 | — |
| SECONDARY N-desmethyl Metabolite of Saracatinib: Time to Cssmax (Tmax) |
2.0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00558272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.