Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Chemotherapy Induced Neutropenia in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Receiving First-Line Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 24
- 主要终点
- Duration of chemotherapy induced neutropenia
研究概览
简要总结
TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel.
详细描述
TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel.
After randomization, patients in Treatment Arm 1, chemotherapy with carboplatin and docetaxel will be administered on Day 1 of each cycle, followed by Telintra at a starting dose of 3000 mg total daily dose (1500 mg orally, twice daily) on Day 2 until the absolute neutrophil count improves as confirmed by two consecutive measurement at least 24 hours apart. In Treatment Arm 2 (control arm), chemotherapy alone consisting of carboplatin and docetaxel will be administered on Day 1 of each cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Histologically confirmed NSCLC
- •Stage IIIb-Stage IV NSCLC
- •ECOG performance status of 0-2
- •Adequate liver and renal function
- •Adequate bone marrow reserve
排除标准
- •Treatment with neoadjuvant or adjuvant chemotherapy within 1 year
- •Histologically confirmed mixed tumors containing small cell elements
- •Treatment with radiotherapy (except limited in nature) within 3 weeks of randomization
- •History of bone marrow transplantation or stem cell support
- •Known history of CNS metastasis unless the patient has had treatment with surgery or radiotherapy, is neurologically stable and does not require oral or IV steroids or anticonvulsants
- •History of HIV
- •Grade 3 or 4 peripheral neuropathy
- •Weightloss greater than 5% within 6 months
- •Uncontrolled pleural effusion
研究组 & 干预措施
ezatiostat hydrochloride (Telintra®)
Chemotherapy with docetaxel and carboplatin followed by Telintra until ANC recovery
干预措施: ezatiostat hydrochloride (Telintra®) (Drug)
结局指标
主要结局
Duration of chemotherapy induced neutropenia
时间窗: 6 weeks
次要结局
- Duration of chemotherapy induced severe neutropenia(6 weeks)
- Time to ANC recovery from ANC nadir(6 weeks)
- Incidence of febrile neutropenia(6 weeks)
- Incidence of G-CSF administration(6 weeks)
- safety assessments(6 weeks)
- FACT-N quality of life assessment(6 weeks)