EUCTR2007-005999-13-PT进行中（未招募）不适用
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 Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 122
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 value of >50 has been relaxed to = 30
- •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
排除标准
- •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) if bone metastases are present and liver function is otherwise considered adequate by the investigator the elevated ALP will not exclude the patient.
- •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 any bone fracture or surgery to bone, including the placement of prosthetic devices in bone, within 12 months of randomisation.
- •12. Evidence of severe or uncontrolled systemic conditions (eg, severe hepatic
- •impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) 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
- •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
研究者
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