Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Eli Lilly and Company
Study ID
NCT00586508
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • enzastaurin — DRUG
    1125 milligrams (mg) loading dose then 500 or 875 mg, orally, daily, 4-week cycles with participants evaluated after each cycle. The dose difference is for participants who are on enzyme-inducing antiepileptic drugs (EIAED) versus non-enzyme inducing antiepileptic drugs (NEIAED).
  • bevacizumab — DRUG
    10 milligrams per kilogram (mg/kg), intravenously (IV), every 2 weeks, participants are evaluated after each cycle (4-week cycles).
  • Enzyme-inducing antiepileptic drugs (EIAED) — DRUG
    Administered orally
  • Non-enzyme inducing antiepileptic drugs (NEIAED) — DRUG
    Administered orally

Study Details

The purpose of this study is to evaluate both enzastaurin and bevacizumab in the treatment of recurrent malignant gliomas.

Key Dates

First listed
Jan 4, 2008
Start date
Nov 30, 2007
Status verified
Sep 2020
Primary completion
Oct 31, 2013
Completion
Oct 31, 2013

Study Design

Enrollment
81 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Enzastaurin + Bevacizumab

Primary Outcome Measure

Progression-Free Survival at 6 Months (PFS-6) [ Time Frame: Registration to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
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.BethesdaMaryland--

Find similar trials in Bethesda, MD

By condition
Brain cancer
By specialty
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By research site
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, MD

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