EUCTR2009-009756-21-FR进行中（未招募）1 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.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 33
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
- •Hypercalcemia of Malignancy (HCM) as defined as documented histologically or cytologically confirmed cancer and a CSC > 12.5 mg/dL (3.1 mmol/L) at screening by local laboratory
- •Last IV bisphosphonate treatment must be = 7 days and = 30 days before the screening CSC
- •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 ULN
- •- serum total bilirubin = 2 x ULN
- •Before any study-specific procedure is performed, the appropriate written informed consent must be obtained
- •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
排除标准
- •Evidence of hyperparathyroidism, hyperthyroidism, adrenal insufficiency, vitamin D intoxication, milk alkali syndrome, sarcoidosis, or other granulomatous disease
- •Receiving dialysis for renal failure
- •Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
- •Active dental or jaw condition which requires oral surgery
- •Non-healed dental/oral surgery
- •Planned invasive dental procedure over the course of the study
- •Prior administration of denosumab
- •Treatment with thiazides, calcitonin, mithramycin, and gallium nitrate within 7 days 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 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
- •Subject (male or female) is not willing to use 2 highly effective methods of contraception during treatment and for 7 months (female) or 10 months (male) after the end of treatment
- •Male subject with a pregnant partner who is not willing to use a condom during treatment and for additional 10 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
研究者
相似试验
进行中（未招募）
不适用
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 - NDEUCTR2009-009756-21-ITAmgen Inc33
进行中（未招募）
不适用
Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum CalciumHypercalcemia of malignancy (HCM)MedDRA version: 15.0Level: LLTClassification code 10020588Term: Hypercalcemia of malignancySystem Organ Class: 10014698 - Endocrine disordersEUCTR2009-009756-21-PLAmgen Inc33
进行中（未招募）
不适用
A multicenter, single arm, proof of concept study to investigate in a first stage the efficacy of a combination therapy of Sandostatin® LAR® and Cabergoline, optionally followed by a combination of Sandostatin® LAR® and pegvisomant, in acromegalic patients only partially responsive to somatostatin analog monotherapy - PHOENIXMedDRA version: M15Level: LLTClassification code 10000599acromegalyEUCTR2005-002919-24-DEovartis Pharma GmbH100
已完成
3 期
A study to assess Efficacy and safety of Ayurvedic Kadha in health and immunity related parameters in mild COVID-19 patients.CTRI/2021/03/032072MARC Laboratories Ltd50
尚未招募
不适用
A prospective, single-arm, multicenter, investigator-initiated, interventional study to evaluate the efficacy and safety of switching from low- and moderate-intensity statin to Ezetimibe 10 mg and ROsuvastatIn 2.5 mg CombinAtion therapy in patients with type 2 diabetes mellitus with dyslipidemia. (EROICA)KCT0008224Hanyang University Guri Hospital665