Enzastaurin Versus Lomustine in Glioblastoma

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00295815
• Date of registration: 22/02/2006
• Prospective Registration: No
• Primary sponsor: Eli Lilly and Company
• Public title: Enzastaurin Versus Lomustine in Glioblastoma
• Scientific title: Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma
• Date of first enrolment: January 2006
• Target sample size: 397
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00295815
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, France, Germany, India, Italy, Mexico, Netherlands, Poland, Spain, United Kingdom, United States

Contacts

• Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Glioblastoma

Intervention(s)

Drug: lomustine

Drug: enzastaurin

Primary Outcome(s)

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). [Time Frame: baseline to measured progressive disease (PD)]

Secondary Outcome(s)

To measure survival to see how the tumor responded to the therapy and how long the response lasted using MRI (a scanning technique). [Time Frame: time of response to progressive disease]

To determine through blood tests how long the medication is in the patient's body. [Time Frame: cycle 1, cycle 4]

To measure changes in patient's ability to care for themselves (this will be determined through a standard survey). [Time Frame: over entire study]

To measure changes from baseline and a neurologic exam. [Time Frame: baseline, each cycle]

To review the effect of the cancer on the patient's ability to care for themselves and on their general health status. [Time Frame: 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. [Time Frame: baseline, cycle 2, end of study]

To review all bad reactions reported by the patient and detected in blood tests. [Time Frame: each cycle]

Secondary ID(s)

9817

H6Q-MC-JCBF

Source(s) of Monetary Support

Please refer to primary and secondary sponsors