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 - MENZA
- Conditions
- Brain metastastases of non-small or small cell lung cancerMedDRA version: 9.1Level: LLTClassification code 10050017Term: Lung cancer metastatic
- Registration Number
- EUCTR2006-000889-36-PL
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 108
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 or 4 Gy x 5. Sites will decide which WBRT schedule will be used. 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 7 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 3 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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method