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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00558272
First Posted: November 14, 2007
Last Update Posted: May 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Breast Cancer Prostate Cancer Bone Neoplasms Drug: AZD0530 Drug: Zoledronic Acid Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4 [ Time Frame: Baseline to 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.


Secondary Outcome Measures:
  • Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase (bALP) at Week 4 [ Time Frame: Baseline to 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.

  • Percentage Change From Baseline in Serum Cross-linked C-terminal Telopeptide of Type I Collagen (ICTP) at Week 4 [ Time Frame: Baseline to 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.

  • Percentage Change From Baseline in Serum N-terminal Propeptide of Type I Procollagen (PINP) at Week 4 [ Time Frame: Baseline to 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.

  • Percentage Change From Baseline in Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) at Week 4 [ Time Frame: Baseline to 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.

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

  • 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 [ Time Frame: Baseline to 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.

  • Saracatinib: Area Under the Curve at Steady State (AUCss) [ Time Frame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29 ]
    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.

  • Saracatinib: Plasma Clearance at Steady State (CLss/F) [ Time Frame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29 ]
  • Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max) [ Time Frame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29 ]
  • Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min) [ Time Frame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29 ]
  • Saracatinib: Time to Cssmax (Tmax) [ Time Frame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29 ]
  • N-desmethyl Metabolite of Saracatinib: Area Under the Curve at Steady State (AUCss) [ Time Frame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29 ]
  • N-desmethyl Metabolite of Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max) [ Time Frame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29 ]
  • N-desmethyl Metabolite of Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min) [ Time Frame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29 ]
  • N-desmethyl Metabolite of Saracatinib: AUCss Metabolite to Parent Ratio [ Time Frame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29 ]
  • N-desmethyl Metabolite of Saracatinib: Time to Cssmax (Tmax) [ Time Frame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29 ]

Enrollment: 139
Study Start Date: February 2008
Study Completion Date: August 2012
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD0530 175 mg
AZD0530 (saracatinib) 175 mg once daily
Drug: AZD0530
Daily oral dose
Other Name: Saracatinib
Experimental: Zoledronic Acid 4 mg
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
Drug: Zoledronic Acid
Other Name: Zometa

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00558272


  Show 28 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Richard Finkelman, DDS, PhD AstraZeneca
Principal Investigator: Meabe Aklilu, MD Wake Forest University Health Sciences
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00558272     History of Changes
Other Study ID Numbers: D8180C00034
First Submitted: November 13, 2007
First Posted: November 14, 2007
Results First Submitted: May 27, 2011
Results First Posted: June 27, 2011
Last Update Posted: May 27, 2013
Last Verified: May 2013

Keywords provided by AstraZeneca:
breast cancer
prostate cancer
metastatic bone disease
Subjects with breast cancer or prostate cancer with metastatic bone disease

Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms
Bone Diseases
Bone Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Musculoskeletal Diseases
Zoledronic acid
Diphosphonates
Saracatinib
Bone Density Conservation Agents
Physiological Effects of Drugs
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action