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A Phase II Trial of Enzastaurin in Combination With Bevacizumab in Adults With Recurrent Malignant Gliomas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Recurrent Glioblastoma

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Trial Information

A Phase II Trial of Enzastaurin in Combination With Bevacizumab in Adults With Recurrent Malignant Gliomas


Inclusion Criteria:



- Patient must be at least 18 years old

- Patient must have been diagnosed with a recurrent brain tumor by MRI scan

- Patient must be willing to practice adequate contraception

- Patient must be able to swallow the Enzastaurin tablets whole and receive Bevacizumab
intravenously

- Patient must agree to use the study drug only as instructed by your study doctor and
staff.

Exclusion Criteria:

- Women who are pregnant or breastfeeding

- Patients who have significant heart, liver, kidney, or psychiatric disease

- Patients who have an active infection

- Patients who have any recent bleeding in the brain

- Patients who are taking any anti-coagulation or anti-platelet medication (including
aspirin, non-steroidal anti-inflammatories, COX-2 inhibitors)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progressive disease

Outcome Time Frame:

baseline to disease progression

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM 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:

11394

NCT ID:

NCT00586508

Start Date:

November 2007

Completion Date:

November 2014

Related Keywords:

  • Recurrent Glioblastoma
  • Glioblastoma
  • Glioma

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.Bethesda, Maryland  20817