EUCTR2013-002223-42-ES进行中（未招募）1 期
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB (PF-04383119) IN SUBJECTS WITH CANCER PAIN PREDOMINANTLY DUE TO BONE METASTASIS RECEIVING BACKGROUND OPIOID THERAPY
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 155
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. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- •2. Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •3. Male or female, 18 years of age or older.
- •4. Weight is at least 45 kg at Screening.
- •5. Subject has prostate cancer, breast cancer, renal cell cancer, lung cancer, colon cancer or multiple myeloma diagnosed as having metastasized to bone.
- •6. Imaging confirmation of bone metastasis at Screening or within 120 days prior to the Screening visit as specified in the protocol. Bone scan confirmation of bone metastasis is required at Screening Visit if radiographic confirmation of bone metastasis within 120 days prior to Screening is lacking.
- •7. Subject is expected to require daily opioid medication throughout the course of the study.
- •8. Subject willing to not use prohibited medications (including NSAIDs) throughout the duration of the study.
- •9. Average Pain Score 5 or higher at Screening for the index bone metastasis cancer pain site.
- •10. Patient's Global Assessment of Cancer Pain must be «fair», «poor» or «very poor» at Screening.
- •11. Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1, or 2 at Screening.
- •12. Adequate bone marrow function at Screening as defined in the protocol.
- •13. Adequate renal function at Screening as defined in the protocol.
- •14. Adequate liver function at Screening as defined in the protocol.
- •15. International Normalized Ratio (INR) or prothrombin time (PT) <1.5 x ULN at Screening (confirmed by a repeat test if needed), provided the subject is not being treated with anticoagulant medication. For subjects being treated with anticoagulants, the INR should be within the range recommended for the specific clinical indication.
- •16. Female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 112 days (16 weeks) after the last dose of assigned subcutaneous study medication.
- •17. Female subjects who are not of childbearing potential (ie, must meet at least one of the following criteria):
- •- Have undergone documented hysterectomy and/or bilateral oophorectomy;
- •- Have medically confirmed ovarian failure; or
- •- Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or
- •physiological cause and have a serum follicle stimulating hormone (FSH) level confirming the post-menopausal state.
- •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 161
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 94
排除标准
- •1. The subject's pain is related to an oncologic emergency.
- •2. The subject has brain metastasis or leptomeningeal metastasis.
- •3. The subject's pain is primarily classified as neuropathic, visceral or unknown in nature, has resulted from prior cancer therapy, is due to infection or is otherwise not predominantly related to a bone metastasis.
- •4. Systemic treatment for the primary malignancy or bone metastasis, including chemotherapy, hormonal treatment, bisphosphonates and denosumab started within 3 months of Screening or new systemic treatment is known to be needed at Screening.
- •5. Receipt of radiopharmaceutical treatment or radiotherapy for treatment of bone metastasis within 4 weeks of Screening.
- •6. Diagnosis of osteoarthritis of the knee or hip as defined by the American College of Rheumatology (ACR) combined clinical and radiographic criteria.
- •7. Subjects with symptoms and radiographic findings consistent with osteoarthritis in the shoulder.
- •8. History or radiographic evidence of orthopedic conditions that may increase the risk of joint safety conditions during the study as defined in the protocol.
- •9. Signs and symptoms of clinically significant cardiac disease within 6 months of the study as defined in the protocol or subjects with any other cardiovascular illness that in the opinion of the investigator would render a subject unsuitable to participate in the study.
- •10. Subjects with orthostatic hypotension or evidence for an autonomic neuropathy at Screening as defined in the protocol.
- •11. History, diagnosis, or signs and symptoms of clinically significant neurological disease as described in the protocol.
- •12. Planned surgical procedure during the duration of the study
- •13. Subjects considered unfit for surgery as defined in the protocol.
- •For the rest of the exclusion criteria, please refer to the protocol
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