Breast CancerPhase 2NCT00558272

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

A Phase 2 study testing AZD0530 and Zoledronic Acid in people with Breast Cancer and Prostate Cancer, run by AstraZeneca at 28 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer, Prostate Cancer, Bone Neoplasms
What is being tested?: AZD0530 and Zoledronic Acid
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 139 participants
Where: 28 sitesin 8 countries
Study dates: Feb 2008to Aug 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

28 sites in 8 countries.

Country

City, postcode or hospital

28 sites in 8 countries

United States9 sites

Research Site
Ann Arbor, Michigan
Research Site
Aventura, Florida
Research Site
Baltimore, Maryland
Research Site
Hershey, Pennsylvania
Research Site
Middlebury, Connecticut
Research Site
Pleasant Hill, California
Research Site
Poughkeepsie, New York
Research Site
Sacramento, California
Research Site
Winston-Salem, North Carolina

Other trials in United States

Canada5 sites

Research Site
Edmonton, Alberta
Research Site
Montreal, Quebec
Research Site
Québec, Quebec
Research Site
Toronto, Ontario
Research Site
Vancouver, British Columbia

Other trials in Canada

Denmark4 sites

Research Site
Arhus N
Research Site
Frederica
Research Site
Herlev
Research Site
Holstebro

Other trials in Denmark

Spain3 sites

Research Site
Barcelona, Catalonia
Research Site
Lleida, Catalonia
Research Site
Valencia, Valencia

Other trials in Spain

United Kingdom3 sites

Research Site
Cardiff
Research Site
Glasgow
Research Site
Manchester

Other trials in United Kingdom

Norway2 sites

Research Site
Kristiansand
Research Site
Oslo

Other trials in Norway

Portugal1 site

Research Site
Lisbon

Other trials in Portugal

Sweden1 site

Research Site
Uppsala

Other trials in Sweden

About this study

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.

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: Breast Cancer, Prostate Cancer, Bone Neoplasms
Being tested: AZD0530, Zoledronic Acid
Keywords: breast cancer, prostate cancer, metastatic bone disease, Subjects with breast cancer or prostate cancer with metastatic bone disease
Medical subject headings: Breast Neoplasms, Prostatic Neoplasms, Bone Neoplasms, Bone Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD0530Drug
Also called Saracatinib
Daily oral dose
Zoledronic AcidDrug
Also called Zometa

Study groups in NCT00558272
Study group	Role	What they receive
AZD0530 175 mg	Experimental	AZD0530 (saracatinib) 175 mg once daily Receives: Drug: AZD0530
Zoledronic Acid 4 mg	Experimental	Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period Receives: Drug: Zoledronic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at 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.
Measured: Baseline to Week 4

Secondary outcomes (16)

Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase (bALP) at 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.
Measured: Baseline to Week 4
Percentage Change From Baseline in Serum Cross-linked C-terminal Telopeptide of Type I Collagen (ICTP) at 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.
Measured: Baseline to Week 4
Percentage Change From Baseline in Serum N-terminal Propeptide of Type I Procollagen (PINP) at 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.
Measured: Baseline to Week 4
Percentage Change From Baseline in Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) at 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.
Measured: Baseline to Week 4
Percentage Change From Baseline in Urine N-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (NTx/Cr) at 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.
Measured: Baseline to Week 4
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
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.
Measured: Baseline to Week 4
Saracatinib: Area Under the Curve at Steady State (AUCss)
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.
Measured: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
Saracatinib: Plasma Clearance at Steady State (CLss/F)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Aug 2012

First posted14 Nov 2007 (estimated)
Study startFeb 2008
Primary completionJan 2010
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00558272
Sponsor's protocol ID: D8180C00034
Status last verified: May 2013
First submitted: 13 Nov 2007
Last updated: 27 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00558272
Acronym / sponsor ID: D8180C00034
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
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 139 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Jan 2010 (actual)
Study completion: Aug 2012 (actual)
First posted: 14 Nov 2007 (estimated)
Results: Posted 27 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
AZD0530 175 mg	Experimental	Drug: AZD0530AZD0530 (saracatinib) 175 mg once daily
Zoledronic Acid 4 mg	Experimental	Drug: Zoledronic AcidZoledronic Acid 4 mg on Day 1 of the 4-week treatment period

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD0530Also: SaracatinibDaily oral dose	Drug	AZD0530 175 mg
Zoledronic AcidAlso: Zometa	Drug	Zoledronic Acid 4 mg

Primary outcome

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.

16 secondary outcomes

Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase (bALP) at Week 4
Time frame: Baseline to Week 4
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
Percentage Change From Baseline in Serum N-terminal Propeptide of Type I Procollagen (PINP) at Week 4
Time frame: Baseline to Week 4
Percentage Change From Baseline in Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) at Week 4
Time frame: Baseline to Week 4
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
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
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
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

Results and safety

Results posted to the registry on 27 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD0530 175 mg	69	56
Zoledronic Acid 4 mg	70	68

Primary outcome: 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. Geometric mean (95% Confidence Interval). Unit: Percentage change in betaCTX

Measure	AZD0530 175 mg n = 46	Zoledronic Acid 4 mg n = 65
Value	-71.1 (-75.9 to -65.4)	-68.4 (-73.0 to -63.2)

Population analysed: The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.

16 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD0530 175 mg	11 of 68 (16.2%)	51 of 68 (75%)	Not reported
Zoledronic Acid 4 mg	4 of 69 (5.8%)	46 of 69 (66.7%)	Not reported

Limitations and caveats (from the sponsor): Non-compliant patients were excluded from the biomarker analysis, in order to accurately assess effects due to treatment. The compliance criteria did not apply to the zoledronic acid arm, which led to an imbalance in the number of subjects analysed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard Finkelman, DDS, PhD study director

AstraZeneca

Meabe Aklilu, MD principal investigator

Wake Forest University Health Sciences

28 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD0530 and Zoledronic Acid in people with Breast Cancer and Prostate Cancer, run by AstraZeneca at 28 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States, Canada, Denmark, Spain, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00558272.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2013; AzTrials last refreshed its copy on 2 Nov 2026.