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Phase 1/2 Study of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Glioblastoma, Glioblastoma Multiforme, Gliosarcoma

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Trial Information

Phase 1/2 Study of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma


Inclusion Criteria:



- 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 Criteria:

- 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.

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:

Phase 1 - To determine the maximum tolerated dose (MTD) of enzastaurin in patients with newly diagnosed GBM or GS

Outcome Time Frame:

until MTD can be deteremined

Safety Issue:

Yes

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:

9815

NCT ID:

NCT00402116

Start Date:

September 2006

Completion Date:

December 2009

Related Keywords:

  • Glioblastoma
  • Glioblastoma Multiforme
  • Gliosarcoma
  • Glioblastoma
  • Gliosarcoma

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 physicianSan Francisco, California