Enzastaurin Versus Lomustine in Glioblastoma

Phase 3

Completed

• Conditions: Glioblastoma
• Interventions: Drug: enzastaurin; Drug: lomustine

• Registration Number: NCT00295815
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-02-22
• Study First Submitted QC: 2006-02-22
• Study First Posted: 2006-02-24
• Primary Completion: 2007-08
• Study Completion: 2014-05
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 397

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	enzastaurin	-
B	lomustine	-

Primary Outcome Measures

Name	Time	Method
The primary objective is to compare Enzastaurin versus Lomustine in patients who for the second time have brain cancer (specifically intracranial glioblastoma) to see what effect the drugs have on keeping the disease from progressing (worsening).	baseline to measured progressive disease (PD)

Secondary Outcome Measures

Name	Time	Method
To measure survival to see how the tumor responded to the therapy and how long the response lasted using MRI (a scanning technique).	time of response to progressive disease
To measure changes from baseline and a neurologic exam.	baseline, each cycle
To review all bad reactions reported by the patient and detected in blood tests.	each cycle
To review the effect of the cancer on the patient's ability to care for themselves and on their general health status.	over entire study
To review through testing of tumor and blood samples to see if there are reasons why some patients responded to the drugs better than other patients.	baseline, cycle 2, end of study
To determine through blood tests how long the medication is in the patient's body.	cycle 1, cycle 4
To measure changes in patient's ability to care for themselves (this will be determined through a standard survey).	over entire study

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇬🇧 Glasgow, Scotland, United Kingdom