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
- Having radiologically proven brain metastases of lung cancer
- Having received whole brain radiotherapy with either 30 grays in 2 weeks or 20 grays
in one week. Treatment with enzastaurin must start within 14 days after the last
fraction of the whole brain radiotherapy
- No other previous radiotherapy to the brain except for radiosurgery at one occasion
- Adequate organ function as measured by appropriate laboratory tests.
- Age 18 years or older.
- Inability to swallow tablets or show conditions which could interfere with oral
medication intake (e.g. vomiting, partial bowel obstruction).
- Inability to discontinue use of certain anti-epileptic drugs such as, carbamazepine,
phenobarbital or phenytoin.
- Concurrent administration of warfarin
- Having had any systemic anti-cancer treatment within the last 2 weeks prior to
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
The primary objective of this study is to compare, in terms of time to worsening of the brain metastases enzastaurin versus placebo when administered to patients who have completed whole brain radiotherapy
Outcome Time Frame:
baseline to measured progressive disease
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Eli Lilly and Company
United States: Food and Drug Administration
- Non Small Cell Lung Cancer
- Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Neoplasm Metastasis
- Small Cell Lung Carcinoma