Prostate Cancer or Breast Cancer with Metastatic Bone Disease Cáncer de próstata o de mama con metástasis óseas
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the effect of AZD0530 plus standard of care (SoC) compared with zoledronic acid plus SoC on bone resorption by assessment of serum beta Cterminal cross-linking telopeptide of Type I collagen (ßCTx) ;Secondary Objective: 1. To investigate the safety and tolerability of AZD0530 in patients with either breast cancer or prostate cancer who have metastatic bone disease by assessment of Adverse Events (AEs), physical examination, blood pressure (BP), pulse, electrocardiogram (ECG), and laboratory findings 2. To estimate the effect of AZD0530 plus SoC on bone turnover (bone resorption and bone formation) by assessment of serum markers bone-specific alkaline phosphatase (bALP), N-terminal propeptide of Type I collagen (PINP), cross-linked C-terminal telopeptide of Type I collagen (ICTP), and tartrate-resistant acid phosphatase 5b (TRAP5b) and urine markers N-terminal cross-linking telopeptide of Type I collagen normalised to creatinine (NTx/Cr) and alpha-alpha C-terminal cross-linking telopeptide of Type I collagen normalised to creatinine (aaCTx/Cr) 3. To investigate the steady state pharmacokinetics (PK) of AZD0530 in this patient population by assessment of appropriate PK parameters ;Primary end point(s): The absolute and percentage change from baseline in serum ßCTX | — |
Countries
Denmark, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed