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Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma

Thank you

Trial Information

Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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).

Outcome Time Frame:

baseline to measured progressive disease (PD)

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

9817

NCT ID:

NCT00295815

Start Date:

January 2006

Completion Date:

November 2013

Related Keywords:

  • Glioblastoma
  • Glioblastoma

Name

Location

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. Denver, Colorado  
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. Iowa City, Iowa  
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. Manhassaet, New York  
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. Durham, North Carolina  
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