Study of Enzastaurin Versus Placebo in the Treatment of Patients With Brain Metastases of Lung Cancer, After Whole Brain Radiation Therapy

Lilly

Status and phase: Completed; Phase 2

Conditions: Small Cell Lung Cancer; Non Small Cell Lung Cancer

Treatments: Drug: enzastaurin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00415363

H6Q-MC-S020 (Other Identifier)

10710

Details and patient eligibility

About

This study is a multinational study to compare enzastaurin versus placebo in the treatment of patients with brain metastases of lung cancer. Approximately 108 patients will be randomly assigned to receive either enzastaurin or placebo after having completed whole brain radiotherapy.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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
• Hemophilia
• Having had any systemic anti-cancer treatment within the last 2 weeks prior to enrolment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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109 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: enzastaurin

B

Placebo Comparator group

Treatment:

Drug: placebo