NCT01582269CompletedPhase 2
A Study in Recurrent Glioblastoma (GB)
A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate Plus Lomustine Therapy Compared to Lomustine Monotherapy in Patients With Recurrent Glioblastoma
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 158 (actual)
- First submitted
- 19 Apr 2012
- Start date
- 26 Apr 2012
- Primary completion date
- 26 Jul 2014
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Glioblastoma
- NCT number
- NCT01582269
- EudraCT number
- 2011-004418-40
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 158
- From 26 Apr 2012 to the primary completion date, 26 Jul 2014
- 29 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Serious concomitant systemic disorder
Other illness
- Moderate or severe heart disease based on New York Heart Association (NYHA) criteria
- Second primary malignancy that may affect the interpretation of results
Other
- Current acute or chronic myelogenous leukemia
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.