A phase II study to assess the efficacy of intravenous loading doses of Bondronat 6 mg on metastatic bone pain in patients with breast cancer and skeletal metastases

Roche (Hellas) S.A.0 个研究点开始时间: 2006年8月9日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Patients with breast cancer and metastatic disease to bone
•- Mean Worst pain score on BPI = 4 over a baseline period of 3 consecutive days
•- Stable dose of analgesics over the 3-day baseline period, variation in daily dose
•remains below 25%
•- Creatinine Clearance = 50 ml/min
•- Karnofsky index > 50%
•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

•- Patients with impending pathological fracture defined as a greater than 50% involvement of a weight bearing bone by malignancy with a lytic or mixed lytic/blastic appearance
•- Patient with change in the type of systemic anti-neoplastic therapy for at least 6 weeks prior to baseline period
•- Patients who have received a bisphosphonate within 3 weeks from the signing of informed consent however, use of bisphosphonates prior to this period is permitted
•- Patients with known hypersensitivity to any of the components of ibandronic acid

发起方

Roche (Hellas) S.A.