An Open-Labeled, Extended-Use of Human Corticotropin-Releasing Factor (hCRF) Intended for Patients Who Participate in Dexamethasone-Sparing Studies NTI 0302, NTI 0303, or Other Designated Studies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 32
- 主要终点
- Long Term Safety and Tolerability of hCRF
研究概览
简要总结
The purpose of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone (Decadron) to treat peritumoral brain edema. This open-label, extended-use study is open to all patients who participate in either of the blinded studies, NTI 0302, NTI 0303, or other designated studies, including patients who may have discontinued blinded study medication early but completed the protocol-stipulated follow-up periods.
详细描述
XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Participation in and completion of stipulated final follow-up periods for study NTI 0302, NTI 0303, or other designated studies.
- •Have a Karnofsky Performance of > 50 at Baseline
- •Capable of self-administration of subcutaneous injections twice daily or availability of assistance from caregiver.
- •Ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed consent.
- •For women of childbearing potential: a negative serum pregnancy test at Baseline
排除标准
- •Concurrent enrollment in any investigational drug or device study, other than NTI 0302, NTI 0303, or other designated studies.
- •Systemic steroid use for any indication other than peritumoral brain edema.
- •Use or intended use of dexamethasone as an anti-emetic during study.
- •Clinical signs and symptoms of cerebral herniation.
- •Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk during study participation.
- •Confounding previous or concurrent neurological disorders that would interfere with adequate clinical evaluation.
- •Clinically significant head injury or chronic seizure disorder, if the condition results in functional impairment or is likely to interfere with evaluations.(Maintenance anticonvulsant therapy is allowed)
- •Central nervous system (CNS) infection.
- •Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for women of childbearing potential.
研究组 & 干预措施
I
All patients will receive hCRF (XERECEPT) 2mg/day
干预措施: hCRF [XERECEPT (corticorelin acetate injection)] (Drug)
结局指标
主要结局
Long Term Safety and Tolerability of hCRF
时间窗: Prospective
Number of patients reporting adverse events
次要结局
未报告次要终点