Phase 2
Completed N=158
A Study in Recurrent Glioblastoma (GB)
Source: ClinicalTrials.gov NCT01582269 ↗Enrolled (actual)
158
Serious AEs
43.0%
Results posted
Nov 2025
Primary outcomePrimary: Overall Survival (OS) — 8.0; 6.7; 7.5 Months
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
8.0; 6.7; 7.5 | — |
| SECONDARY Progression Free Survival (PFS) |
1.8; 1.8; 1.9 | — |
| SECONDARY Percentage of Participants With Tumour Response |
0.0; 1.3; 0.0; 5.1; 0.0; 0.0 | — |
| SECONDARY Population Pharmacokinetics (PopPK): Absorption Rate Constant of Galunisertib (Arm A: Galunisertib and Arm B: Galunisertib + Lomustine) |
2.28 | — |
| SECONDARY Population Pharmacokinetics (PopPK): Mean Steady State Apparent Volume of Distribution (Vss) of Galunisertib (Arm A: Galunisertib and Arm B: Galunisertib + Lomustine) |
175 | — |
| SECONDARY Population Pharmacokinetics (PopPK): Mean Population Clearance of Galunisertib (Arm A: Galunisertib and Arm B: Galunisertib + Lomustine) |
37.5 | — |
| SECONDARY Change From Baseline in Neurocognitive Function Using Hopkins Verbal Learning Test-Revised (HVLT-R) |
-0.2; -0.2; -0.3; -0.8; 0.0; 0.1 | — |
| SECONDARY Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom and Interference Severity Scores: (Brain Tumor Symptoms, Core Symptoms, Interference Symptoms) |
0.0; 0.3; -0.3; 0.0; 0.3; 0.3 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01582269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.