A Study in Recurrent Glioblastoma (GB)
Status: | Active, not recruiting |
---|---|
Conditions: | Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/6/2018 |
Start Date: | April 26, 2012 |
End Date: | December 31, 2019 |
A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate Plus Lomustine Therapy Compared to Lomustine Monotherapy in Patients With Recurrent Glioblastoma
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
plus lomustine therapy or lomustine plus placebo can help participants with brain cancer
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:
- 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
We found this trial at
6
sites
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