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

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ClinicalTrials.gov Identifier: NCT00558272
Recruitment Status : Completed
First Posted : November 14, 2007
Results First Posted : June 27, 2011
Last Update Posted : May 27, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE November 13, 2007
First Posted Date  ICMJE November 14, 2007
Results First Submitted Date  ICMJE May 27, 2011
Results First Posted Date  ICMJE June 27, 2011
Last Update Posted Date May 27, 2013
Study Start Date  ICMJE February 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2007)
To estimate the effect of AZD0530 plus standard of care (SoC) compared with Zoledronic acid plus SoC on bone resorption [ Time Frame: 4 weeks ]
Change History Complete list of historical versions of study NCT00558272 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2007)
To investigate the safety and tolerability of AZD0530 in patients with either breast cancer or prostate cancer who metastatic bone disease [ Time Frame: 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease
Official Title  ICMJE 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.
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Prostate Cancer
  • Bone Neoplasms
Intervention  ICMJE
  • Drug: AZD0530
    Daily oral dose
    Other Name: Saracatinib
  • Drug: Zoledronic Acid
    Other Name: Zometa
Study Arms  ICMJE
  • Experimental: AZD0530 175 mg
    AZD0530 (saracatinib) 175 mg once daily
    Intervention: Drug: AZD0530
  • Experimental: Zoledronic Acid 4 mg
    Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
    Intervention: Drug: Zoledronic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2011)
139
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2007)
122
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Denmark,   Norway,   Portugal,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00558272
Other Study ID Numbers  ICMJE D8180C00034
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Richard Finkelman, DDS, PhD AstraZeneca
Principal Investigator: Meabe Aklilu, MD Wake Forest University Health Sciences
PRS Account AstraZeneca
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP