A Phase II, Randomised, Open-label, Pilot Study to Evaluate the Safety and the Effects on Bone Resorption of AZD0530 in Patients with Prostate Cancer or Breast Cancer with Metastatic Bone DiseaseEnsayo piloto, fase II, abierto y aleatorizado para evaluar la seguridad y los efectos de AZD0530 sobre la resorción ósea en pacientes con cáncer de próstata o de mama con metástasis óseas

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 122

Inclusion Criteria

1. Provision of signed, written informed consent
2. Age 18 years and older
3. Histologically or cytologically confirmed breast (female only) or prostate cancer
4. At least one radiographically confirmed metastatic bone lesion
5. No change of cancer therapy for at least 8 weeks before randomisation
6. Urinary NTx/Cr >50 nmol BCE/mmol creatinine
7. World Health Organisation (WHO) performance status 0 to 2
8. Life expectancy of more than 12 weeks
9. Negative pregnancy test if female and of child-bearing potential

For inclusion in this exploratory biomarker research, patients must:
1. Provide informed consent for exploratory biomarker research

For inclusion in this genetic research, patients must:
1. Provide informed consent for genetic research

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Brain metastases or risk of spinal cord compression, unless treated at least 4 weeks before entry, and stable without steroid treatment for 1 week OR
New neurological symptoms or signs consistent with acute or evolving spinal cord
compression confirmed with magnetic resonance imaging (MRI) (stable,
previously-treated patients are allowed) OR Other central nervous system metastatic involvement
2. Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count <1.5 x 10 to the power of 9/L or platelet count <100 x 10 to the power of 9/L
3. Haemoglobin = 9g/dL (5.59 mMol/L) (blood transfusion permitted following
discussion with AstraZeneca Study Physician)
4. 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)
5. Impaired renal function, defined by creatinine =1.5 times the ULRR or creatinine
clearance of = 50 mL/min determined by Cockcroft-Gault formula; or = +2
proteinuria on 2 consecutive dipsticks taken no less than 24 hours apart
6. Any prior exposure to bisphosphonate therapy
7. Have a planned change in cancer therapy before completion of the 4 week treatment period
8. Have received in the previous 4 weeks any of the following:
- cytotoxic chemotherapy
- chemotherapy with novel, molecularly targeted agents
9. Are receiving, or have received in the previous 12 months, any of the following:
- PTH/ PTH analogue
- Vitamin D analogues (eg, calcitriol)/ treatment with Vitamin D at doses of 1200 IU or greater for a period of three months or more
10. Prior treatment with radiopharmaceuticals or radiotherapy to bone (focal
radiotherapy of localised, non-target bone lesions would be permitted if completed
up to 4 weeks prior to study entry)
11. Have had hip fractures or bilateral hip prosthesis, fracture of any kind, or surgery to bone within 12 months of randomisation
12. Evidence of severe or uncontrolled systemic conditions (eg, severe hepatic
impairment) or current unstable or uncompensated respiratory or cardiac conditions
which makes it undesirable for the patient to participate in the study or which could
jeopardise compliance with the protocol
13. Pregnant or breast-feeding women
14. Unwillingness to use an acceptable method of contraception while on study (for
women and men where female partner is of child bearing potential). (Postmenopausal status will be considered adequate evidence of non-childbearing
potential and is defined as any 1 of the following: natural menopause with last
menses >1 year ago; radiation induced oophorectomy with last menses >1 year ago.
Women with prior bilateral oophorectomy or hysterectomy will also be considered
not of childbearing potential).
15. Unresolved toxicity = CTCAE grade 2 from previous anti-cancer therapy except
alopecia
16. Resting ECG with measurable QTc interval of >480 msec at 2 or more time points
within a 24 hour period of each other
17. Concomitant use of any medication or herbal supplement that may significantly
modulate CYP3A4 activity or the activity of which is significantly modified by
CYP3A4 (with special regard to those calcium channel antagonists that are
CYP3A4 substrates). Such drugs must have been discontinued for approximately 2
weeks or more prior to starting the study medication except for pimozide,
astemizole and amiodarone where the time inte

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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