Clinical trial · Interventional
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.
NCT00558272CI-TRIAL-00010430completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Neoplasms | Bone Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD0530 | Drug | — | UNRESOLVED |
| Zoledronic Acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AZD0530 175 mg
- description
- AZD0530 (saracatinib) 175 mg once daily
- interventionNames
- Drug: AZD0530
- type
- EXPERIMENTAL
- label
- Zoledronic Acid 4 mg
- description
- Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
- interventionNames
- Drug: Zoledronic Acid
Primary outcomes (1)
- measure
- Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4
- timeFrame
- Baseline to Week 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.