Clinical trial NCT00558272: Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Prostate Cancer
Bone Neoplasms
Keywords: breast cancer
prostate cancer
metastatic bone disease
Subjects with breast cancer or prostate cancer with metastatic bone disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-11-14
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
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
Secondary outcomes:
measure: Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase (bALP) at Week 4
timeFrame: Baseline to Week 4
measure: Percentage Change From Baseline in Serum Cross-linked C-terminal Telopeptide of Type I Collagen (ICTP) at Week 4
timeFrame: Baseline to Week 4
measure: Percentage Change From Baseline in Serum N-terminal Propeptide of Type I Procollagen (PINP) at Week 4
timeFrame: Baseline to Week 4
measure: Percentage Change From Baseline in Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) at Week 4
timeFrame: Baseline to Week 4
measure: Percentage Change From Baseline in Urine N-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (NTx/Cr) at Week 4
timeFrame: Baseline to Week 4
measure: 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
timeFrame: Baseline to Week 4
measure: Saracatinib: Area Under the Curve at Steady State (AUCss)
timeFrame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
measure: Saracatinib: Plasma Clearance at Steady State (CLss/F)
timeFrame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
measure: Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)
timeFrame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
measure: Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)
timeFrame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
measure: Saracatinib: Time to Cssmax (Tmax)
timeFrame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
measure: N-desmethyl Metabolite of Saracatinib: Area Under the Curve at Steady State (AUCss)
timeFrame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
measure: N-desmethyl Metabolite of Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)
timeFrame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
measure: N-desmethyl Metabolite of Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)
timeFrame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
measure: N-desmethyl Metabolite of Saracatinib: AUCss Metabolite to Parent Ratio
timeFrame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
measure: N-desmethyl Metabolite of Saracatinib: Time to Cssmax (Tmax)
timeFrame: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
Other outcomes:
Locations:
city: Pleasant Hill
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: Middlebury
country: United States
facility: Research Site
state: Connecticut
city: Aventura
country: United States
facility: Research Site
state: Florida
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Poughkeepsie
country: United States
facility: Research Site
state: New York
city: Winston-salem
country: United States
facility: Research Site
state: North Carolina
city: Hershey
country: United States
facility: Research Site
state: Pennsylvania
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Arhus N
country: Denmark
facility: Research Site
city: Frederica
country: Denmark
facility: Research Site
city: Herlev
country: Denmark
facility: Research Site
city: Holstebro
country: Denmark
facility: Research Site
city: Kristiansand
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
state: Cataluna
city: Lerida
country: Spain
facility: Research Site
state: Cataluna
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Uppsala
country: Sweden
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Richard Finkelman, DDS, PhD
role: STUDY_DIRECTOR
affiliation: Wake Forest University Health Sciences
name: Meabe Aklilu, MD
role: PRINCIPAL_INVESTIGATOR
References: