Enzastaurin Versus Lomustine in Glioblastoma

Lilly

Status and phase: Completed; Phase 3

Conditions: Glioblastoma

Treatments: Drug: lomustine; Drug: enzastaurin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00295815

9817

H6Q-MC-JCBF (Other Identifier)

Details and patient eligibility

About

This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme).

Enrollment: 397 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient presents with histologically confirmed diagnosis of brain cancer (specifically glioblastoma multiforme).
2. Your cancer has returned following therapy.
3. Patient may have undergone prior surgery to remove cancer.
4. Patient must be able to care for self.

Exclusion criteria

1. Have a second type of cancer (except adequately treated basal cell carcinoma of the skin). Patient who has had another cancer in the past, must be free of cancer for more than 2 years.
2. Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of entry.
3. Patients receiving medication for seizures must discontinue 14 days prior to enrolling.
4. Cannot be on blood thinning medication at study enrollment.
5. Cannot be on other medicines to prevent cancer at study enrollment.
6. Patients are not allowed to enter the study if they have previously taken Enzastaurin, Lomustine and/or Bevacizumab.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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397 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: enzastaurin

B

Active Comparator group

Treatment:

Drug: lomustine