NCT00896454已完成2 期
A Single-arm, Multicenter, Proof-of-concept Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium Despite Recent Treatment With IV Bisphosphonates
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a Response Within 10 Days of First Dose of Denosumab
研究概览
简要总结
The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia of Malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates by lowering corrected serum calcium </= 11.5 mg/dL (2.9 millimoles /L) by day 10.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Hypercalcemia of Malignancy (HCM) as defined as documented histologically or cytologically confirmed cancer and a corrected serum calcium (CSC) > 12.5 mg/dL (3.1 millimoles /L) at screening by local laboratory
- •Last IV bisphosphonate treatment must be >/= to 7 days and </= to 30 days before the screening corrected serum calcium
- •Adults (>/=18 years)
- •Adequate organ function as defined by the following criteria:
- •serum aspartate aminotransferase (AST) </= 5 x upper limit of normal (ULN)
- •serum alanine aminotransferase (ALT) </= 5 x upper limit of normal
- •serum total bilirubin </= 2 x upper limit of normal
排除标准
- •Evidence of benign hyperparathyroidism, hyperthyroidism, adrenal insufficiency, vitamin D intoxication, milk alkali syndrome, sarcoidosis, or other granulomatous disease
- •Receiving dialysis for renal failure
- •Treatment with thiazides, calcitonin, mithramycin, or gallium nitrate within their window of expected therapeutic effect (as determined by the physician) prior to the date of the screening CSC
- •Treatment with cinacalcet within 4 weeks prior to the date of the screening CSC
- •Thirty days or less since receiving an investigational product (other than denosumab) or device (ie, does not have marketing authorization; thalidomide use is allowed) in another clinical study
- •Known sensitivity to any of the products to be administered during the study (eg, mammalian derived products)
- •Female subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment
- •Female subject of childbearing potential is not willing to use 2 highly effective methods of contraception during treatment and for 7 months after the end of treatment
- •Subject will not be available for follow-up assessment.
- •Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
研究组 & 干预措施
denosumab
Experimental
Eligible subjects will receive denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study days 8 and 15.
干预措施: denosumab (Drug)
结局指标
主要结局
Percentage of Participants With a Response Within 10 Days of First Dose of Denosumab
时间窗: 10 days
Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was \< 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium \[mg/dL\] + (0.8 x (4 - serum albumin \[g/dL\]))
次要结局
- Percentage of Participants With a Response by Visit(Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57)
- Duration of Complete Response(From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.)
- Time to Response(From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.)
- Time to Complete Response(From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.)
- Time to Relapse/Nonresponse of Hypercalcemia of Malignancy(From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.)
- Change From Baseline in Corrected Serum Calcium(Baseline and Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57)
- Percentage of Participants With a Complete Response by Visit(Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57)
- Duration of Response(From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study of Denosumab in Multiple Myeloma Patients With Renal InsufficiencyMultiple MyelomaNCT02833610Massachusetts General Hospital55
已完成
2 期
Efficacy and Safety of Namilumab (MT203) for Plaque PsoriasisPlaque PsoriasisNCT02129777Takeda122
已完成
3 期
A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of DenosumabOsteoporosis, PostmenopausalNCT01495000GlaxoSmithKline250
已完成
3 期
A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of DenosumabOsteoporosis, PostmenopausalNCT01457950GlaxoSmithKline135
已完成
3 期
Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot StudyBone DensityBone LossEating DisorderAtypical Anorexia NervosaAnorexia NervosaNCT03292146Massachusetts General Hospital30