PHASE II OPEN-LABEL SAFETY EXTENSION STUDY OF TANEZUMAB IN CANCER PATIENTS WITH PAIN DUE TO BONE METASTASES

Pfizer Inc 235 East 42nd Street New York, NY 100170 个研究点目标入组 58 人开始时间: 2010年11月2日最近更新: 2013年5月27日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 58

研究概览入排标准研究者记录与标识符相似试验

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

•1. The patient must consent in writing to participate in the study by signing and dating an informed consent document indicating that the patient has been informed of all pertinent aspects of the study prior to conducting any study-related procedures.
•2. The patient met the eligibility criteria for, and was randomized and treated with intravenous study drug in Study A4091003.
•3. At least 8 weeks but no more than 16 weeks has elapsed since the intravenous study drug infusion in Study A4091003.
•4. Female patients must meet one of the following criteria:
•a. Female patients of non-childbearing potential: must be post menopausal, defined as women who are = 45 years old with amenorrhea for 24 consecutive months (regardless of FSH levels at Study A4091003 Screening) or women who are amenorrheic for at least 1 year AND have a serum follicle stimulating hormone (FSH) level greater than 30 IU/L at Study A4091003 Screening; or be surgically sterile, defined as having had a hysterectomy and/or bilateral oophorectomy;
•b. Female patients of child bearing potential: must not be pregnant or lactating and must be abstinent or use adequate contraception (2 forms of birth control, one of which must be a barrier method) from Baseline visit until 16 weeks after the last dose of study medication. Women of childbearing potential must have a negative erum pregnancy test at Study A4091003 Termination Visit or a negative urine regnancy test at Baseline prior to initial dosing.
•Male patients must agree that they and their female spouses/partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non childbearing potential.
•In the event of indeterminate or anomalous results on pregnancy/FSH testing or issues surrounding contraceptive requirements, study management should be contacted and will make the final decision as to the adequacy/need for contraception.
•5. The patient has a Karnofsky Performance Score =40% at Baseline;
•6. The patient has an anticipated life expectancy of =6 months at Baseline;
•7. The patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
•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

•Patients presenting with any of the following will not enter the study:
•1. The patient was withdrawn from Study A4091003 for an adverse event or serious adverse event.
•2. Use of any investigational medication within 30 days prior to Baseline or plans to receive an investigational medication other than the study medication during the course of this study.
•3. Patients who discontinued Study A4091003 prior to Week 8 because of lack of compliance, protocol violation, not meeting entrance criteria, withdrawal of consent, disease progression or patients who were lost to follow up will be excluded from Study A4091029.
•4. Occurrence of any adverse event or condition during Study A4091003 or since termination from that study that, in the opinion of the Investigator, would put the patient at increased safety risk or should exclude the subject from participating in the open-label extension.
•5. Known history of:
•a. Rheumatoid arthritis;
•b. Seronegative spondyloarthropathy (eg, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel disease-related arthropathy);
•c. Primary avascular necrosis of the bone in any location. Necrosis of the bone secondary to radiotherapy (ie, osteoradionecrosis) and in relation to metastatic disease of the bone (ie, involving the tumour-bone interface) is allowable.
•6. History of significant trauma to a major joint within one year prior to Screening;
•7. Known history or evidence of osteoarthritis (OA):
•a. Patients should be excluded if they have evidence of OA in the hips, knees or hands as defined by the American College of Rheumatology Criteria (clinical criteria alone or combined clinical and radiographic criteria).
•b. Patients with signs and symptoms consistent with osteoarthritis of the other joints such as shoulder, wrist, and ankle should be excluded. Investigators may obtain an X-ray of the joint if needed to establish the diagnosis of OA.
•c. Patients with persistent back pain and OA of the spine should be excluded. Intervertebral disc degeneration without accompanying bony changes consistent with osteoarthritis is allowable.

研究者

发起方

Pfizer Inc 235 East 42nd Street New York, NY 10017

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