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

NCT00558272 | Completed Phase 2 Results DMC

• 1 other identifier: D8180C00034
• Study Type: interventional
• Target: 139
• Locations: 8 countries
• Sites: 28

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 4

Secondary Outcomes (16)

• Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase (bALP) at Week 4

  Baseline to Week 4

• Percentage Change From Baseline in Serum Cross-linked C-terminal Telopeptide of Type I Collagen (ICTP) at Week 4

  Baseline to Week 4

• Percentage Change From Baseline in Serum N-terminal Propeptide of Type I Procollagen (PINP) at Week 4

  Baseline to Week 4

• Percentage Change From Baseline in Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) at Week 4

  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

  Baseline to Week 4

Study Arms (2)

AZD0530 175 mg

EXPERIMENTAL

AZD0530 (saracatinib) 175 mg once daily

Drug: AZD0530

Zoledronic Acid 4 mg

EXPERIMENTAL

Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period

Drug: Zoledronic Acid

Interventions

AZD0530 DRUG

Daily oral dose

Also known as: Saracatinib

AZD0530 175 mg

Zoledronic Acid DRUG

Also known as: Zometa

Zoledronic Acid 4 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (28)

Research Site

Pleasant Hill, California, United States

Location

Research Site

Sacramento, California, United States

Location

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Middlebury, Connecticut, United States

Location

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Aventura, Florida, United States

Location

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Baltimore, Maryland, United States

Location

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Ann Arbor, Michigan, United States

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Poughkeepsie, New York, United States

Location

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Winston-Salem, North Carolina, United States

Location

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Hershey, Pennsylvania, United States

Location

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Edmonton, Alberta, Canada

Location

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Vancouver, British Columbia, Canada

Location

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Toronto, Ontario, Canada

Location

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

Location

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Arhus N, Denmark

Location

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Frederica, Denmark

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Herlev, Denmark

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Holstebro, Denmark

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Kristiansand, Norway

Location

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Oslo, Norway

Location

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Lisbon, Portugal

Location

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Barcelona, Catalonia, Spain

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Lleida, Catalonia, Spain

Location

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Valencia, Valencia, Spain

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Uppsala, Sweden

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Cardiff, United Kingdom

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Glasgow, United Kingdom

Location

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Manchester, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Bone Neoplasms; Bone Diseases

Interventions

saracatinib; Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Richard Finkelman, DDS, PhD

  AstraZeneca

  STUDY DIRECTOR

• Meabe Aklilu, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 14, 2007
• Study Start: February 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: August 1, 2012
• Last Updated: May 27, 2013
• Results First Posted: June 27, 2011

Record last verified: 2013-05

Locations

PT (1); SE (1); GB (3); ES (3); CA (5); NO (2); US (9); DK (4)