EUCTR2006-000889-36-DK进行中（未招募）不适用
A Double-blind, Randomized, Placebo-controlled Multicentre Phase II Study of Maintenance Enzastaurin Following Whole Brain Radiation Therapy in the Treatment of Brain Metastases from Lung Cancer - N/A
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 108
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
- •Patients are eligible to be included in the study only if they meet all of the following criteria:
- •[1]Histologically or cytologically proven SCLC or NSCLC
- •[2]Brain metastases radiologically proven prior to start of WBRT.
- •If solitary brain metastasis: Surgery or radiosurgery should be considered first. If not eligible for surgery or radiosurgery, the patient may be included in the study.
- •[3]Having received WBRT with either 3 Gy x 10, 4 Gy x 5 or 5 Gy x 4. Sites will decide which WBRT schedule will be used. Preferably, one fractionation scheme should be used for all patients enrolled at each site.
- •[4]No other previous radiotherapy to the brain will be allowed except for radiosurgery at one occasion
- •[5]Patients must be able to start enzastaurin within 14 days after the last fraction of WBRT.
- •[6]ECOG performance status 0 to 2. (See protocol attachment S020.6)
- •[7]Patients must have adequate organ function, including the following:
- •Adequate bone marrow reserve: white blood cell (WBC) count ?3.0 ? 109/L, absolute neutrophil count (ANC) ?1.5 ? 109/L, platelet count ?75 ? 109/L and hemoglobin ? 9 g/dL.
- •Hepatic: bilirubin ?2 times the upper limit of normal (ULN); alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) ?3 ? ULN, or ?5 ? ULN with liver metastases
- •Renal: serum creatinine ?1.5 ULN.
- •[8]Age 18 years or older
- •[9]For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after the treatment period; Women with reproductive potential must have a negative serum or urine pregnancy test within 7 days before study enrollment and must not be breast-feeding.
- •For men: Must be surgically sterile, or compliant with a contraceptive method during and for 3 months after the treatment period.
- •[10]Written informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •[11]Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •[12]Have previously completed or withdrawn from this study or any other study investigating enzastaurin
- •[13]Are unable to swallow tablets or show conditions which could interfere with oral medication intake (e.g. vomiting, partial bowel obstruction.
- •[14]Are unable to discontinue use of carbamazepine, phenobarbital or phenytoin (refer to Section 5.7) prior to inclusion. The investigator may prescribe non-EIAEDs. However if the patient requires therapy with these drugs after starting enzastaurin treatment, the patient may remain on study therapy
- •[15]Having concurrent administration of warfarin
- •[16]Showing hemophilia
- •[17]Having had any systemic anti-cancer treatment within the last 2 weeks prior to enrolment.
- •[18]Showing conditions – medical, social, psychological – which could prevent adequate information and follow-up
- •[19]Showing serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) that in the opinion of the investigator, would compromise the safety of the patient or his/her ability to complete the study
- •[20]Having clinically active cancer other than the NSCLC / SCLC
研究者
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