Status:
COMPLETED
Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
University of California, San Francisco
Conditions:
Glioblastoma
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
There will be 2 phases in this study. Patients will either be enrolled to the first phase or to the second phase, depending upon when they enroll into the study. The first phase of this study is done...
Eligibility Criteria
Inclusion
- Patients must have a histologically confirmed diagnosis of intracranial glioblastoma multiforme (GBM) or gliosarcoma (GS).
- Biopsy or resection must have been performed no more than 5 weeks prior to treatment.
- An MRI or CT scan must be obtained within 14 days prior to treatment.
- Patients must not have received prior drug therapy for brain tumors.
- Patients must have adequate organ function demonstrated by lab tests within 14 days prior to treatment.
Exclusion
- Patients will be excluded if unable to swallow tablets.
- Patients will be excluded if unable to discontinue use of enzyme inducing antiepileptic drugs or have been off of these agents less than 2 weeks prior to treatment (i.e. phenytoin (Dilantin®), carbamazepine, etc.).
- Patients will be excluded if have active infection.
- Patients will be excluded if have a significant medical illness that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
- Patients will be excluded if they have concurrent therapy with an anticoagulant. If the patient requires anticoagulant therapy after starting treatment, the patient may remain on study but should be monitored carefully.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00402116
Start Date
September 1 2006
End Date
December 1 2009
Last Update
August 6 2020
Active Locations (1)
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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
San Francisco, California, United States