NCT00993239已完成1 期
A Phase 1, Open-Label, Non-randomized, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TL32711 in Adults With Refractory Solid Tumors or Lymphoma
TetraLogic Pharmaceuticals3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Define the MTD
研究概览
简要总结
A Phase 1 open-label, non-randomized dose escalation study to determine the maximum tolerated dose (MTD) and characterize the safety and tolerability of Birinapant (TL32711).
详细描述
The purpose of this Phase 1 open-label, non-randomized dose escalation study is to determine the maximum tolerated dose (MTD) and characterize the safety and tolerability of Birinapant (TL32711) when administered as a 30 minute intravenous infusion once weekly for three weeks per repeated 4 week intervals in subjects with refractory solid tumors or lymphoma. Additionally study will assess anti-tumor activity, pharmacokinetics, and exploratory biomarkers as a measurement of pharmacodynamic effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Advanced metastatic or unresectable malignancy that is refractory to currently available standard therapies or no effective therapy exists. The subject's malignancy must be confirmed by prior pathologic study.
- •Evaluable disease (measurable or non-measurable) by Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1) or Revised Response Criteria for Malignant Lymphoma (RRCML) (Cheson 2007).
- •Life expectancy greater than 3 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- •Adequate renal function, defined as serum creatinine ≤ 1.5 X upper limit of normal (ULN), or calculated creatinine clearance ≥ 60 ml/min.
- •Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 3 X ULN and total bilirubin < 1.5 X ULN.
- •Adequate bone marrow function, defined as absolute neutrophil (ANC) ≥ 1,500/mm3 (≥1.5 X106/L), platelet count ≥ 75,000/mm3 (≥ 75 X106/L), and hemoglobin ≥ 10 mg/dL in the absence of transfusion.
排除标准
- •Recent anti-cancer treatment defined as:
- •Standard or investigational anti-cancer therapy within 4 weeks prior to first dose of TL
- •Exception: continued hormonal interventions for sensitive diseases.
- •Radiation therapy within 2 weeks prior to the first dose of TL
- •Clinically significant pulmonary illness resulting in Grade ≥ 2 hypoxia (National Cancer Institute Common Terminology criteria for Adverse Events [NCI CTCAE, v4]) or any requirement for supplemental oxygen, or pulse oximetry less than 90% saturation on room air.
- •Symptomatic or uncontrolled brain metastases requiring current treatment (less than 4 weeks from last cranial radiation or 2 weeks from last steroids).
- •Impaired cardiac function or clinically significant cardiac disease.
- •Ongoing auto-immune disease or with history of an auto-immune disease within the past 5 years. Auto-immune disease include but are not limited to systemic lupus erythematosis, scleroderma, rheumatoid arthritis, psoriasis, psoriatic arthritis, ulcerative colitis and regional enteritis (Crohn's disease).
- •Systemic or chronic topical corticosteroids or immunosuppressive therapy within 4 weeks prior to study entry or anticipated need of systemic corticosteroids or immunosuppressive therapy during study participation.
- •Skin lesions of Grade ≥ 2 severity (NCI CTCAE v4), except alopecia.
- •Lack of recovery of prior adverse events to Grade ≤1 severity (NCI CTCAE v 4) (except alopecia or neuropathy) due to medications administered prior to the first dose of TL32711.
研究组 & 干预措施
Birinapant (TL32711)
Experimental
干预措施: Birinapant (TL32711) (Drug)
结局指标
主要结局
Define the MTD
时间窗: 4 weeks (Cycle 1)
次要结局
- Translational biomarkers and pharmacokinetics(First and third dose of Cycle 1 and after every two cycles (biomarkers only) while on treatment)
- Tumor burden according to Response Evaluation Criteria in Solid Tumors (RECIST)/Revised Response Criteria Malignant Lymphoma(Every 8 weeks (2 cycles) while on treatment)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
1 期
Phase 1 Study of EZN-2968 Weekly in Adult Patients With Advanced Solid Tumors or LymphomaCarcinomaLymphomaNCT00466583Enzon Pharmaceuticals, Inc.52
已完成
1 期
Study of a c-Met Inhibitor PLB1001 in Patients With PTPRZ1-MET Fusion Gene Positive Recurrent High-grade GliomasGliomaNCT02978261Beijing Pearl Biotechnology Limited Liability Company18
终止
1 期
PF-07284892 in Participants With Advanced Solid TumorsSolid TumorNCT04800822Pfizer53
已完成
1 期
A Study of JAB-3312 in Adult Patients With Advanced Solid Tumors in ChinaPancreatic Ductal CarcinomaEsophageal Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaOther Solid TumorsBreast CancerColorectal CancerNon-small Cell Lung CancerNCT04121286Allist Pharmaceuticals, Inc.17
终止
1 期
Safety and Tolerability Study of AZD7762 in Combination With GemcitabineSolid TumorsAdvanced Solid MalignanciesCancerNCT00937664AstraZeneca24