A phase II, open label study to establish the safety and efficacy of intravenous loading dose of 3 x Bondronat 6 mg in 3 consecutive days in patients with breast cancer and skeletal metastases experiencing moderate to severe pain.

The BONiFIN study group0 个研究点目标入组 60 人开始时间: 2006年4月6日最近更新: 2012年3月19日

试验速览

暂无简介。

•-Histological or cytological evidence of breast cancer
•-Presence of bone metastases documented on bone x-ray, bone scintigram, CT scan or MRI scan before inclusion into the trial.
•-Worst pain score in movement or in rest of = 4 on the VAS during the previous 24 hours before the Screening visit.
•-After the optimization of the analgesic dose worst pain score in movement or in rest of = 4 on the VAS during the previous 24 hours before the visit on Day 1.
•-Bone pain must correspond to areas of metastases on bone x-ray, bone scintigram, CT scan or MRI scan; 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 ensure that each patient’s pain is primarily due to bone metastases.
•-The use of at least a weak opioid based on the WHO analgesic ladder (Appendix 7) during the baseline period
•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)
•F.1.3.1 Number of subjects for this age range

•Patients with an active infection or with a fever > 38.50 C within 3 days of the first scheduled day of ibandronate dosing
•Patients with an impending pathological fracture
•Patients with known medulla compression.
•Patients, who have received an intravenous bisphosphonate within 4 weeks before baseline/screening.
•Patients with known hypersensitivity to any of the components of ibandronate
•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 in any country.

发起方

The BONiFIN study group