NL-OMON54624招募中2 期
Individualized pemetrexed dosing in patients with non-small cell lung cancer or mesothelioma based on renal function to improve treatment response - The IMPROVE-I, -II and -III studies - - IMPROVE
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •IMPROVE-I,
- •1. >=18 years old
- •2. Eligible for treatment with pemetrexed-based chemotherapy based on indication
- •3A. For the first three patients (cohort 1): estimated creatinine clearance of
- •30-45 mL/min
- •3B. For every next patient (cohort 2): estimated creatinine clearance <45ml/min
- •4. ECOG performance score of 0-2
- •5. Subject is able and willing to sign the Informed Consent Form
- •IMPROVE-II
- •1. >=18 years old
- •2. Eligible for treatment with pemetrexed-based chemotherapy
- •3. Creatinine clearance >45ml/min
- •4. ECOG performance score of 0-2
- •5. Subject is able and willing to sign the Informed Consent Form,
- •IMPROVE-III
- •1. >=18 years old
- •2. Planned for treatment with pemetrexed-based chemotherapy
- •3. ECOG performance score of 0-2
- •4. Subject is able and willing to sign the Informed Consent Form
排除标准
- •IMPROVE-I, -II and -III
- •1. Conditions that affect haemostasis in a way that blood drawing is
- •complicated (to be assessed by physician)
- •2. Contraindications for treatment with pemetrexed in line with the SmPC
- •(except for creatinine clearance <45 ml/min in IMPROVE-I)
- •a.Hypersensitivity to the active substance or to any of the excipients
- •b.Pregnancy or lactation
- •c. Concomitant yellow fever vaccine
- •3. The presence of clinically relevant pharmacokinetic interactions, according
- •to the current SmPC
- •4. Obesity (defined as a body mass index (BMI) >40 kg/m2)
- •5. Limb amputation
- •6. Use of trimethoprim and/or cimetidine
- •additional for IMPROVE-I:
- •7. Baseline absolute neutrophil count <1.5*109/L
研究者
相似试验
进行中（未招募）
不适用
Pemetrexed monochemotherapy in patients with locally advanced or metastatic Non Small Cell Lung Cancer. A pilot study to define the best dosing schedule for a planned phase II randomized trial. - NDIIIB and IV non-small cell lung cancerMedDRA version: 9.1Level: LLTClassification code 10026532Term: Malignant neoplasm of thoraxEUCTR2006-001836-32-ITELI LILLY
已完成
2 期
A Phase 2 Study of Pemetrexed in Patients with Previously Treated Non-Squamous Non-Small-Cell Lung CancerJPRN-UMIN000002467Kobe Lung Cancer Study Group45
已完成
不适用
The combination therapy of pemetrexed and continued EGFR-TKIs beyond disease progression to first-line EGFR-TKIs treatments in elderly patients with advanced non-small-cell lung cancer harboring EGFR mutations: a phase 2 trial.non-small-cell lung cancerJPRN-UMIN000010935Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine22
招募中
不适用
Study of pemetrexed in previously-treated patients with advanced squamous cell lung carcinoma having low level of TSKCT0003518CC Hospital32
进行中（未招募）
不适用
A Phase II Dose-Finding Study of weekly pemetrexed in combination with Radiotherapy in locally advanced pancreatic adenocarcinoma - NDEUCTR2007-002936-27-ITISTITUTO ONCOLOGICO ROMAGNOLO