A Study in Recurrent Glioblastoma (GB)
About the study
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
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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
EXCLUSION CRITERIA
Exclusion Criteria:
- 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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Glioblastoma
Age (in years)
18+
Phase
Phase 2
Participants needed
180
Est. Completion Date
Dec 31, 2023
Treatment type
Interventional
Sponsor
Eli Lilly and Company
ClinicalTrials.gov identifier
NCT01582269
Study number
H9H-MC-JBAL
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