A Study in Recurrent Glioblastoma (GB)

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Lomustine

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:

• 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