EUCTR2005-002802-48-IT进行中（未招募）不适用
Evaluation of efficacy and safety of i.v. and oral ibandronate in elderly patients with bone metastases from solid tumors. A randomised phase II study - ND
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ROCHE
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
- •Histological or cytological evidence of solid tumor (breast cancer, hormone-refractory prostate cancer, lung cancer and all others). Patients with prostate cancer must have progressive neoplastic disease despite at least 3 months of hormonal therapy, defined as a rise in PSA on 3 separate occasions at least 2 weeks apart or clear evidence of new bone metastases
- •Presence of bone metastases documented on bone scan and bone x-ray or CT scan or MRI
- •Mean pain score of >5 over a 7-day Screening period on the WORST PAIN scale of the BPI
- •Bone pain must correspond to areas of metastases on bone scintigram and bone x-ray or CT scan or MRI; patients whose pain is primarily due to visceral disease (e.g., liver metastases) or to neuropathy should be excluded. It is the responsibility of the investigator to insure that each patient's pain is primarily due to bone metastatic disease.
- •Age >70 years
- •The use of at least a weak opioid based on the WHO Analgesic ladder
- •No change in systemic anti-neoplastic therapy for at least 6 weeks prior to Screening period
- •WHO Performance Score of 0 ? 2
- •Adequate renal function as evidenced by serum creatinine <2.0 mg/dL (168 ?mol/L)
- •Normal serum calcium level
- •Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •Patients with an active infection or with a fever >38.50 C within 3 days of the first scheduled day of dosing
- •Patients with an impending pathological fracture (erosion of at least 1/3 of the cortex by neoplastic process)
- •Patients with known symptomatic CNS or meningeal metastases
- •Patients who have received a bisphosphonate within 3 weeks of the start of the Screening period; however, use of bisphosphonates prior to this period is permitted
- •Patients with known hypersensitivity to any of the components of ibandronic
- •Patient requiring a dentistry intervention which planned duration is more than one month (Patient requiring a dentistry intervention which planned duration is less than one month can be enrolled only after dentistry intervention)
- •Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of dosing; investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication. ?Investigational therapy? does not refer to approved agents used in a clinical trial in an off-label manner, e.g., in a different dose or schedule, or in a non-approved tumor.
- •Radiotherapy to bone within 4 weeks of the Screening period
- •Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
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