A Study in Subjects With Recurrent Malignant Glioma

Part of paid clinical trials in Tampa, Florida.

Sponsor
Eisai Inc.
Study ID
NCT01137604
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Lenvatinib — DRUG
    24 mg lenvatinib capsules orally, once daily continuously in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.
  • Bevacizumab — DRUG
    Bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.

Study Details

An open-label phase 2, multicenter study in participants with recurrent malignant glioma.

Key Dates

First listed
Jun 4, 2010
Start date
Nov 9, 2010
Status verified
May 2016
Primary completion
Mar 19, 2013
Completion
Oct 28, 2014

Study Design

Enrollment
151 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Cohort 1 assessed participants with recurrent Grade 4 malignant glioma (ie, glioblastoma \[GBM\]) who were bevacizumab-naive. Participants were planned to be accrued in Cohort 1 and randomized in a 1:1 ratio to receive lenvatinib (experimental) or bevacizumab (active comparator). Cohort 1 - Bevacizumab Cohort 1 - Lenvatinib
  • Experimental: Cohort 2
    Cohort 2 assessed participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive. Participants in Cohort 2 were planned to be treated with lenvatinib.
  • Experimental: Cohort 3
    Cohort 3 assessed participants with recurrent GBM who had disease progression following prior bevacizumab treatment. Participants in Cohort 3 were planned to be treated with lenvatinib.

Primary Outcome Measure

Progression Free Survival (PFS) Rate at Month 6 [ Time Frame: At Month 6 from randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) ]

Locations (3)

FacilityCityStateZIPSite coordinators
-TampaFlorida--
-BostonMassachusetts--
-DurhamNorth Carolina--

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By specialty
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