NCT02101164撤回4 期
An Open-Label, Multicentre Trial to Evaluate the Time Associated With the Preparation and Administration of Denosumab and Pamidronate in Subjects With Solid Tumors and Metastatic Bone Disease in Canada
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Amgen
- 主要终点
- Total duration (in hours, minutes and seconds) for investigational product preparation and administration
研究概览
简要总结
This study will estimate the total time for the preparation and administration of denosumab and the total time for the preparation and administration of pamidronate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of metastatic bone disease secondary to a solid tumor (eg, breast cancer, lung cancer, etc).
- •An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Subject is one of the following:
- •being considered for pamidronate IV infusions or denosumab SC injections for treatment of metastatic bone disease (prescribed per Canadian product monograph); OR
- •scheduled to receive pamidronate IV infusions or denosumab SC injections for treatment of metastatic bone disease (prescribed per Canadian product monograph); OR
- •currently receiving pamidronate IV infusions or denosumab SC injections for treatment of metastatic bone disease AND has received no more than 4 prior administration of either product combined (prescribed per Canadian product monograph).
- •Subject has a serum calcium or albumin-adjusted serum calcium ≥ 2.0 mmol/L (8.0 mg/dL) and ≤ 2.9 mmol/L (11.5 mg/dL)
排除标准
- •Diagnosis with metastatic bone disease secondary to multiple myeloma or prostate cancer.
- •Severe renal impairment (creatinine clearance < 30 mL/min)
- •Subject is being considered for ambulatory pamidronate administration using an infuser device (ie, "baby bottle").
- •A known active infection with Hepatitis B virus or Hepatitis C virus.
- •Subject has known positive results for human immunodeficiency virus (HIV).Subject has a history of other malignancy within the past 5 years, other than:
- •Malignancy treated with curative intent and with no known active disease present for ≥ 5 years before enrollment and felt to be at low risk for recurrence by the treating physician
- •Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •Adequately treated cervical carcinoma in situ without evidence of disease
- •Adequately treated breast ductal carcinoma in situ without evidence of disease
- •Prostatic intraepithelial neoplasia without evidence of prostate cancer
- •Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
- •Subject has a history or current evidence of osteonecrosis/osteomyelitis of the jaw, active dental or jaw condition that requires oral surgery, non-healed dental/oral surgery, or planned invasive dental procedure over the course of the study.
研究组 & 干预措施
Treatment Group A
Active Comparator
1 dose of denosumab every 4 weeks for 2 doses, followed by 1 dose of pamidronate every 4 weeks for 2 doses.
干预措施: denosumab (Biological)
Treatment Group A
Active Comparator
1 dose of denosumab every 4 weeks for 2 doses, followed by 1 dose of pamidronate every 4 weeks for 2 doses.
干预措施: pamidronate (Drug)
Treatment Group B
Active Comparator
1 dose of pamidronate every 4 weeks for 2 doses, followed by 1 dose of denosumab every 4 weeks for 2 doses.
干预措施: denosumab (Biological)
Treatment Group B
Active Comparator
1 dose of pamidronate every 4 weeks for 2 doses, followed by 1 dose of denosumab every 4 weeks for 2 doses.
干预措施: pamidronate (Drug)
结局指标
主要结局
Total duration (in hours, minutes and seconds) for investigational product preparation and administration
时间窗: Week 13
次要结局
未报告次要终点
研究者
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