This study is in progress, not accepting new patients

A Study in Recurrent Glioblastoma (GB)

a study on Astrocytoma Glioblastoma Glioma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study start
estimated completion

Description

Summary

The purpose of the study is to see whether treatment with LY2157299 on its own, LY2157299 plus lomustine therapy or lomustine plus placebo can help participants with brain cancer

Official Title

A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate Plus Lomustine Therapy Compared to Lomustine Monotherapy in Patients With Recurrent Glioblastoma

Keywords

Glioblastoma, Lomustine, LY2157299 monohydrate, LY2157299 monohydrate plus lomustine

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histological confirmed diagnosis of relapsed intracranial GB
  • Progressive Disease (PD) following standard chemoradiation
  • Prior surgical resection allowed
  • Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1
  • Adequate hematologic, hepatic and renal function
  • Discontinued all prior cancer treatments for cancer & recovered from the acute effects of therapy
  • Tumor specimen must be available for a central pathology review and prognostic and predictive biomarker evaluation

You CAN'T join if...

  • Moderate or severe heart disease based on New York Heart Association (NYHA) criteria
  • Prior nitrosurea therapy (including lomustine or Gliadel)
  • Prior bevacizumab as 1st line treatment for GB (if treatment was concluded 12 months prior to enrollment, the patient may be eligible to participate in the trial)
  • Current acute or chronic myelogenous leukemia
  • Second primary malignancy that may affect the interpretation of results
  • Serious concomitant systemic disorder

Locations

  • San Francisco California 94143 United States
  • La Jolla California 92093 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT01582269
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 180 study participants
Last Updated