NCT00051779已完成1 期
A 24-Week Blinded Study Conducted at Multiple Centers, Evaluating the Safety and Effectiveness of Various Doses of the Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) When Randomly Assigned to Patients With Breast Cancer That Has Metastasized to Bone
Chugai Pharma USA74 个研究点 分布在 1 个国家开始时间: 2003年1月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 74
研究概览
简要总结
This study is intended to evaluate the safety, tolerability, and possible effectiveness of an investigational humanized monoclonal antibody (CAL) to the parathyroid hormone-related protein (PTHrP) when compared to zoledronic acid in patients with breast cancer metastatic to bone.
The study will also evaluate the possible effects of both study drugs on performance status, markers of bone metabolism, and skeletal events related to bone metastasis including elevated blood calcium levels, bone pain, metastatic lesions, complications and interventions. The levels of CAL in the blood will also be evaluated.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Major Inclusion Criteria - Others Stipulated within the Protocol
- •The study physician must assure you have/are:
- •Must be a female at least 18 years of age and be using an effective form of birth control.
- •A documented history of breast cancer and at least one bone metastasis that has not been previously treated by radiation or surgery, and is not anticipated to be treated within the next 24 weeks.
- •A total body bone scan and other radiographic scan(s) performed on you within 4 weeks prior to or during the screening period sufficient to image all sites of bone metastases.
- •You must be willing to perform a daily telephone diary and be willing to keep a paper diary and provide voluntary consent to participate in this study.
排除标准
- •Others Stipulated within the Protocol
- •The study physician must assure you do not have/are not:
- •A change in analgesic (pain relief) type medication during the screening period (example, non-narcotic to narcotic).
- •Received radiation therapy to any bone metastasis or started a new course of chemotherapy within 3 weeks prior to the screening visit or during the screening period.
- •Used any bisphosphonate type drug during the 30 days prior to the anticipated first dose of study drug
- •Vertebral spine or weight-bearing bone metastasis that would place you at imminent risk for fracture or surgical intervention.
- •Evidence of active infection or immune deficiency, renal failure, abnormal liver function, or a serum calcium level > 10.1 mg/dL.
- •Use of any investigational drug within 30 days prior to screening.
研究者
研究点 (74)
Loading locations...
相似试验
已完成
3 期
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)Diabetes Mellitus, Type 2NCT00094770Merck Sharp & Dohme LLC1,172
已完成
3 期
A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)Vitamin D DeficiencyOsteoporosisNCT00092066Organon and Co717
终止
2 期
A Randomized Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Effects of Alagebrium on Exercise in Subjects With Diastolic Heart FailureDiastolic Heart FailureNCT01913301Cardiovascular Clinical Studies134
已完成
3 期
A Study of MK0217A and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)OsteoporosisVitamin D DeficiencyNCT00092079Merck Sharp & Dohme LLC652
Unknown
不适用
Safety and Efficacy Study of the Z-Lig Medical Device Compared to AllograftRuptured Anterior Cruciate LigamentsNCT01245400Aperion Biologics, Inc.60